Figure 1.
Figure 2.
Figure. 3-1.
Figure 4.
Figure 5.
j_aoj-2025-0015_UAtab_002
| Number | Article | Reason for exclusion |
|---|---|---|
| 1 | Levrini L, Salone GS, Ramirez-Yanez GO. Pre-Fabricated Myofunctional Appliance for the Treatment of Mild to Moderate Pediatric Obstructive Sleep Apnea: A Preliminary Report. J Clin Pediatr Dent. 2018;42(3):236-9. | Inclusion criterion for control not met |
| 2 | Dinkova M. Vertical Control of Overbite in Mixed Dentition by Trainer System. Journal of IMAB - Annual Proceeding (Scientific Papers). 2014;20:648-54. | Inclusion criterion for control not met |
| 3 | Levrini L, Persano R, Piantanida S, Carganico A, Deppieri A, Naboni G, et al. The Effects of the Myobrace(®) System on Peripheral Blood Oxygen Saturation (SpO(2)) in Patients with Mixed Dentition with Oral Dysfunction. Dent J (Basel). 2023;11(8). | Inclusion criterion for control not met |
| 4 | Alhasyimi AA, Syahfik I. Growth Modification of Developing Class II Division 1 Malocclusion Using Myofunctional Appliances. Case Rep Dent. 2023;2023:8201195. | Case report |
| 5 | Rezky Oktaviyani R, Harun A, Wesley K, Iriani F, Nurwahidah A, Sulfina H, et al. Myobrace versus twin block in the treatment of class II malocclusion in Children: A systematic review. Saudi Dent J. 2024;36(5):661-4. | Review article |
| 6 | Ahn ES, Kim AH, Shim YS, An SY. Oropharyngeal Airway Three-dimensional Changes after Treatment with Myobrace in Class II Retrognathic Children. Iran J Public Health. 2017;46(2):265-7. | Case report |
| 7 | Cheng HW, Ho CT, Kao CT. A useful method to correct early unilateral posterior crossbite. J Dent Sci. 2022;17(3):1401-2. | Case report |
| 8 | Aggarwal I, Wadhawan MC, Dhir V, Kumar A. Myobraces: Say No to Traditional Braces. Int J Oral Care Res. 2016;4(1):82-5. | Review article |
| 9 | Achmad H, Auliya N. Management of Malocclusion in Children Using Myobrace Appliance: A Systematic Review. F1000Research. 2024;13:53. | Review article |
| 10 | Mohammed H, C̈irgić E, Rizk MZ, Vandevska-Radunovic V. Effectiveness of prefabricated myofunctional appliances in the treatment of Class II division 1 malocclusion: a systematic review. Eur J Orthod. 2020;42(2):125-34. | Review article |
| 11 | Achmad H, Horax S, Singgih M, Samad R, Sumintarti S, Rieuwpassa I, et al. The effectiveness of myobrace on the treatment of Malocclusion and bad habits in children. Int J Health Sci. 2022:4073-82. | Review article |
| 12 | Anastasi G, Dinnella A. Myobrace System: a no-braces approach to malocclusion and a myofunctional therapy device. Webmed Cent Orthod. 2014;5:WMC004492. | Review article |
| 13 | Ramirez-Yañez GO, Flutter J, editors. Facial Symmetry Improves After Treating Malocclusions with the Myobrace™ System. Ec Dental Science. 2016; 712. | Inclusion criterion for control not met |
| 14 | Rautela M, Aeran H, Dhawan P. Myobrace: From braces to no braces. Guident. 2017;10(9),28. | Case report |
| 15 | Elnaili SA, Bushwigeer SS, Alzway AA, editors. Myobrace as an alternative to conventional orthodontics treatment. 2019. | Not a clinical study |
| 16 | Wishney M, Darendeliler MA, Dalci O. Myofunctional therapy and prefabricated functional appliances: an overview of the history and evidence. Australian dental journal. 2019;64(2):135-44. | Review article |
| 17 | Ahn ES, Kim AH, Shim YS, An SY. Oropharyngeal Airway Three-dimensional Changes after Treatment with Myobrace in Class II Retrognathic Children. Iran. J. Public Health. 2017;46(2):265-7. | Not a clinical study |
| 18 | Dinkova M. Vertical control of overbite in mixed dentition by Trainer system. J IMAB. 2014 Oct-Dec;20(5):648-54. | Case report |
| 19 | Tripathi NB, Patil SN. Treatment of class II division 1 malocclusion with myofunctional trainer system in early mixed dentition period. The journal of contemporary dental practice. 2011;12(6):497-500. | Case report |
| 20 | Uysal T, Yagci A, Kara S, Okkesim S. Influence of pre-orthodontic trainer treatment on the perioral and masticatory muscles in patients with Class II division 1 malocclusion. Eur J Orthod. 2012;34(1):96-101. | Focus on muscle activity |
| 21 | Quinzi V, Gallusi G, Carli E, Pepe F, Rastelli E, Tecco S. Elastodontic Devices in Orthodontics: An In-Vitro Study on Mechanical Deformation under Loading. Bioengineering. 2022;9(7). | Focus on material properties |
| 22 | Yagci A, Uysal T, Kara S, Okkesim S. The effects of myofunctional appliance treatment on the perioral and masticatory muscles in Class II, Division 1 patients. World J Orthod. 2010;11(2):117-22. | Focus on muscle activity |
| 23 | Cheng HW, Ho CT, Kao CT. A useful method to correct early unilateral posterior crossbite. J Dent Sci. 2022;17(3):1401-2. | Case report |
| 24 | Dinu S, Buzatu R, Macasoi I, Popa M, Vlad CS, Marcovici I, et al. Toxicological Profile of Biological Environment of Two Elastodontic Devices. Processes. 2021;9(12):2116. | Focus on material properties |
| 25 | Satygo EA, Silin AV, Ramirez-Yañez GO. Electromyographic muscular activity improvement in Class II patients treated with the pre-orthodontic trainer. J Clin Pediatr Dent. 2014;38(4):380-4. | Focus on muscle activity |
| 26 | Tripathi NB, Patil SN. Treatment of class II division 1 malocclusion with myofunctional trainer system in early mixed dentition period. J Contemp Dent Pract. 2011;12(6):497-500. | Case report |
| 27 | Saccomanno S, Antonini G, D’Alatri L, D’Angelantonio M, Fiorita A, Deli R. Patients treated with orthodontic-myofunctional therapeutic protocol. Eur J Paediatr Dent. 2012;13(3):241-3. | Case report |
| 28 | Pachori Y, Navlani M, Gaur T, Bhatnagar S. Treatment of skeletal class II division 1 malocclusion with mandibular deficiency using myofunctional appliances in growing individuals. J Indian Soc Pedod Prev Dent. 2012;30(1):56-65. | Case report |
j_aoj-2025-0015_UAtab_001
| Table A. Search strategy for Medline via PubMed (n=55) | |
| #1 | “Myobrace” [Title/Abstract] |
| #2 | “The Trainer System” [Title/Abstract] |
| #3 | “Trainer for Kids” [Title/Abstract] |
| #4 | “T4K”[Title/Abstract] |
| #5 | #1 or #2 or #3 or #4 |
| Table B. Search strategy for EMBASE (n=40) | |
| #1 | ‘Myobrace’ |
| #2 | ‘The Trainer System’ |
| #3 | ‘Trainer for Kids’ |
| #4 | ‘T4K’ |
| #5 | #1 OR #2 OR #3 OR #4 |
| Table C. Search strategy for Web of Science (n=155) | |
| #1 | TI: (Myobrace) |
| #2 | TI: (The Trainer System) |
| #3 | TI: (Trainer for Kids) |
| #4 | TI: (T4K) |
| #5 | #1 or #2 or #3 or #4 |
| Table D. Search strategy for CENTRAL (The Cochrane Library) (n=9) | |
| #1 | Myobrace:ti,ab,kw |
| #2 | “The Trainer System”:ti,ab,kw |
| #3 | “Trainer for Kids”):ti,ab,kw |
| #4 | T4K:ti,ab,kw |
| #5 | #1 or #2 or #3 or #4 |
| Table E. Search strategy for ClinicalTrials.gov (n=30) | |
| #1 | Myobrace |
| #2 | “The Trainer System” |
| #3 | “Trainer for Kids” |
| #4 | T4K |
| #5 | #1 OR #2 OR #3 OR #4 |
| Table F. Search strategy for China National Knowledge Infrastructure (n=73) | |
| #1 | |
| #2 | |
| #3 | |
| #4 | #1 OR #2 OR #3 |
Characteristics of the 13 included studies
| Study (Author year) | Country | Study design | Sample size | Age (years) | Myobrace group | Compa rison group | Treatment time | Outcomes | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Dentoalveolar | Skeletal | Soft tissue | |||||||||
| 1 | Ramirez-Yañez 200725 | USA | NRS | 120 | 8.3 ± 1.0 | T4K® (n=60) | No treatment (n = 60) | 6 months | U6-6(mm), U3-3(mm), L6-6(mm), L3-3(mm) | N/A | N/A |
| 2 | C̈rgić 201530 | Sweden | RCT | 97 | 7-14 | Myobrace® (n=57) | Activator (n=40) | 12 months | Overjet, Overbite | sagittal relation, | lip seal |
| 3 | Sun 201821 | China | RCT | 20 | 8-11 | Myobrace® (n=10) | Activator (n=10) | 6 months | L1-NB(mm), L1-NB(°), U1-NA(mm), U1-NA(°), Co-Pg, Overjet, Overbite | SNA, SNB, ANB | N/A |
| 4 | Idris 201922 | Syria | RCT | 60 | 10.3 ± 1.4 | T4K® (n=30) | Activator (n=30) | 12-18 months | Overjet, Overbite, Ls to E, Li to E, U1-SN | SNA, SNB, ANB, N-Me, N-ANS, ANS-Me, MP-FH | N/A |
| 5 | Elhamouly 202026 | Egypt | RCT | 20 | 9-12 | T4K® (n=10) | Twin-Block (n=10) | 18-24 months | Overjet, U1-FHP, L1-MP, Is-APog(mm), li-NB(mm), U6-PL.P (mm), L6-MP(mm), mi-PtV(mm), UAP(mm), LAP(mm) | N/A | N/A |
| 6 | Hanoun 202023 | America | RCT | 43 | 11-14 | T4F (n=21) | Twin-Block (n=22) | 10-12 months | Overjet, Overbite, Sv_is (mm), Sv_ii (mm), Sv_ii (mm) | SNA, SNB, ANB, Sn-Man(°), MMPA(°) | N/A |
| 7 | Ji 202027 | China | RCT | 25 | 9.1 ± 1.3 | Myobrace® (n=13) | Twin-Block (n=12) | 12 months | U1-SN(mm), U1-SN(°), L1-NB(mm), L1-NB(°), L1-MP, Overjet, Overbite | SNA, SNB, ANB, FH-MP, NP-FH | N/A |
| 8 | Xie 202019 | China | RCT | 22 | 9.7 ± 1.3 | Myobrace® (n=11) | Twin-Block (n=11) | 12 months | U1-NA mm), U1-NA (°), L1-NB (mm), L1-NB (°), Po-NB (mm), | SNA, SNB, ANB, FMA, FH-MP, Y-axis (°), NP-FH (°), SN-FH (°) | N/A |
| 9 | Chen 202128 | China | NRS | 40 | 12.43 ± 0.76 | Myobrace® (n=20) | Twin-Block (n=20) | 6 months | U1-SN, L1-MP | SNA, SNB, ANB, FH-MP, Y axis, NP-FH | CmSnLs( ° ), A’Ls-FH(°), IMsLs-FH(°), IMsLs-FH(°), LiB’Pg’(°), GSnPg’(°) |
| 10 | Johnson 202131 | UAE | RCT | 20 | 10.40 ± 1.89 | Myobrace® (n=10) | Twin-Block (n=10] | 9 months | U1-NA (mm), U1-NA (°), L1-NB (mm), L1-NB (°), U1-SN, Overjet, Overbite, U6-6(mm), L6-6(mm) | SNA, SNB, ANB, NA-Pog, PP-MP, Ar-Gn, Go-Ar, Go-Me | N/A |
| 11 | Habumugisha 202224 | China | NRS | 145 | 7.41 ± 1.21 | Myobrace® (n=75) | No treatment (n=70) | 12 months | U1-NA (°), L1-NB(°), Overjet, Overbite, U6-6(mm), U3-3(mm), L6-6(mm), L3-3(mm) | SNA, SNB, ANB, FH-MP, SN-GoGn, S-Go | N/A |
| 12 | Çoban Büyükbayraktar and Camci (2023)13 | Turkey | NRS | 36 | 12.14 ± 1.23 | Myobrace® (n=18) | Twin-Block (i=18) | 12-16 months | U1-NA (mm), U1-NA (°), L1-NB (mm), L1-NB (°), U1-SN (°), Overjet, Overbite, Pg-NB (mm), FMA (°) | SNA, SNB, ANB, FMA (°), FMIA (°), | Upper lip-E line, Lower lip-E line |
| 13 | Madian 202312 | Egypt | RCT | 26 | 9 – 12 | Myobrace® (n = 13) | Twin-Block (n=13) | 16 months | N/A | SNA, SNB, ANB, Wits appraisal, FMA | phaiyngeal airway area |
j_aoj-2025-0015_UAtab_004
| Author(s): | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Date: 2024-08-04 | ||||||||||||
| Question: MRC vs TB for [Malocclusion] | ||||||||||||
| Settings: | ||||||||||||
| Bibliography:. [Myobrace] for [Malocclusion], Cochrane Database of Systematic Reviews [Year], Issue [Issue]. | ||||||||||||
| Quality assessment | No of patients | Effect | ||||||||||
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | MRC | TB | Relative (95% Cl) | Absolute | Quality | Importance |
| SNA (Better indicated by lower values) | ||||||||||||
| 7 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 106 | 101 | – | MD 0.36 higher (0.06 to 0.66 higher) | ⊕⊕⊕⊕○ MODE RATE | |
| SNB (Better indicated by lower values) | ||||||||||||
| 7 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 101 | 101 | – | MD 0.38 lower (1.36 lower to 0.59 higher) | ⊕○○○ VERY LOW | |
| ANB (Better indicated by lower values) | ||||||||||||
| 6 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 90 | 90 | – | MD 0.19 higher (0.86 lower to 1.24 higher) | ⊕○○○ VERY LOW | |
| FMA(°) (Better indicated by lower values) | ||||||||||||
| 5 | randomised trials | no serious risk of bias | serious3 | no serious indirectness | serious1 | none | 75 | 74 | – | MD 0.26 higher (1.19 lower to 1.7 higher) | ⊕⊕○○ LOW | |
| Ar-Go(mm) (Better indicated by lower values) | ||||||||||||
| 2 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 23 | 22 | – | MD 1.51 lower (2.87 to 0.15 lower) | ⊕⊕⊕○ MODERATE | |
| Go-Me(mm) (Better indicated by lower values) | ||||||||||||
| 2 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 23 | 22 | – | MD 2.19 higher (0.37 to 4.02 higher) | ⊕⊕⊕○ MODERATE | |
| Y-axis(°) (Better indicated by lower values) | ||||||||||||
| 2 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 31 | 31 | – | MD 2.33 higher (5.58 lower to 10.24 higher) | ⊕○○○ VERY LOW | |
| Overbite(mm) (Better indicated by lower values) | ||||||||||||
| 3 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 41 | 40 | – | MD 0.83 higher (0.1 to 1.55 higher) | ⊕⊕⊕○ MODERATE | |
| Overjet(mm) (Better indicated by lower values) | ||||||||||||
| 5 | randomised trials | no serious risk of bias | serious3 | no serious indirectness | serious1 | none | 65 | 65 | – | MD 1.45 higher (0.1 to 2.79 higher) | ⊕⊕○○ LOW | |
| U1-SN(°) (Better indicated by lower values) | ||||||||||||
| 5 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 72 | 71 | – | MD 0.29 lower (5.94 lower to 5.36 higher) | ⊕○○○ VERY LOW | |
| U1-NA(°) (Better indicated by lower values) | ||||||||||||
| 4 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 52 | 51 | – | MD 0.3 higher (3.96 lower to 4.55 higher) | ⊕○○○ VERY LOW | |
| U1-NA(mm) (Better indicated by lower values) | ||||||||||||
| 4 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 52 | 51 | – | MD 0.3 higher (0.64 lower to 1.24 higher) | ⊕⊕⊕○ MODE RATE | |
| Ll-NB(mm) (Better indicated by lower values) | ||||||||||||
| 4 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 52 | 51 | – | MD 0.34 higher (1.1 lower to 1.78 higher) | ⊕○○○ VERY LOW | |
| L1-MP(°) (Better indicated by lower values) | ||||||||||||
| 6 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 80 | 79 | – | MD 1.79 higher (1.2 lower to 4.77 higher) | ⊕○○○ VERY LOW | |
| L1-NB(°) (Better indicated by lower values) | ||||||||||||
| 4 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 52 | 51 | – | MD 3.64 higher (3.05 lower to 10.32 higher) | ⊕○○○ VERY LOW | |
| SNA(°) (Better indicated by lower values) | ||||||||||||
| 2 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 40 | 40 | – | MD 0.03 higher (0.55 lower to 0.61 higher) | ⊕⊕⊕○ MODERATE | |
| SNB(°) (Better indicated by lower values) | ||||||||||||
| 2 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 40 | 40 | – | MD 0.86 lower (1.51 to 0.21 lower) | ⊕⊕⊕○ MODERATE | |
| ANB(°) (Better indicated by lower values) | ||||||||||||
| 2 | randomised trials | no serious risk of bias | very serious2 | no serious indirectness | serious1 | none | 40 | 40 | – | MD 0.32 higher (1.23 lower to 1.87 higher) | ⊕○○○ VERY LOW | |
| U1-SN(°) (Better indicated by lower values) | ||||||||||||
| 2 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 40 | 40 | – | MD 0.24 higher (2.18 lower to 2.67 higher) | ⊕⊕⊕○ MODERATE | |
| Overjet (Better indicated by lower values) | ||||||||||||
| 2 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious1 | none | 40 | 40 | – | MD 0.51 higher (0.25 lower to 1.27 higher) | ⊕⊕⊕○ MODERATE | |
| U3-3(mm) (Better indicated by lower values) | ||||||||||||
| 2 | observational studies | no serious risk of bias | very serious1 | no serious indirectness | serious2 | none | 135 | 130 | – | MD 1.19 higher (0 to 2.37 higher) | ⊕○○○ VERY LOW | |
| U6-6(mm) (Better indicated by lower values) | ||||||||||||
| 2 | observational studies | no serious risk of bias | very serious1 | no serious indirectness | serious2 | none | 135 | 130 | – | MD 0.86 higher (0.3 lower to 2.01 higher) | ⊕○○○ VERY LOW | |
| L3-3(mm) (Better indicated by lower values) | ||||||||||||
| 2 | observational studies | no serious risk of bias | no serious inconsistency | no serious indirectness | serious2 | none | 135 | 130 | – | MD 0.1 lower (0.26 lower to 0.06 higher) | ⊕○○○ VERY LOW | |
| L6-6(mm) (Better indicated by lower values) | ||||||||||||
| 2 | observational studies | no serious risk of bias | very serious1 | no serious indirectness | serious2 | none | 135 | 130 | – | MD 0.7 higher (0.71 lower to 2.11 higher) | ⊕○○○○ VERY LOW | |
Summary of risk bias of Non-Randomized Study (NRS) included in the study based on Methodological Index for Non-Randomized Studies (MINORS) scores (0-8 points: low quality; 9-16 points: medium quality; 17-24 points: high quality)
| Assessment criteria | Ramirez-Yañez (2007)25 | Chen (2021)28 | Habumugisha (2022)24 | Çoban Büyükbayraktar and Camcı (2023)13 |
|---|---|---|---|---|
| Clear research objectives | 2 | 2 | 2 | 2 |
| Continuity of inclusion of patients | 2 | 2 | 2 | 2 |
| Expected data collection | 2 | 2 | 2 | 2 |
| Outcome indicators reflect appropriately research purpose | 2 | 2 | 2 | 2 |
| Outcome measure objectivity | 0 | 1 | 2 | 2 |
| Whether the follow-up time was sufficient | 2 | 2 | 2 | 2 |
| The rate of lost to follow-up | 0 | 0 | 0 | 2 |
| Whether to estimate the sample size | 0 | 0 | 1 | 2 |
| Whether the control group was appropriate | 2 | 2 | 2 | 2 |
| Whether the control group is synchronized | 0 | 0 | 2 | 0 |
| Intergroup baseline | 1 | 0 | 2 | 0 |
| Reliability of data statistics | 2 | 2 | 2 | 2 |
| Total | 15 | 15 | 21 | 20 |
| Quality level | Medium | Medium | High | High |
j_aoj-2025-0015_UAtab_003
| Item | Authors’ judgment | Description |
|---|---|---|
| Ramirez-Yañez 200725 (NRS) | ||
| Aim of the study clear | 2 | Comments: The author gives a clear research purpose |
| Inclusion of consecutive patients | 2 | Comment: Patients who met the inclusion criteria were included during the study period |
| Prospective collection of data | 2 | Comments: The authors collected the indicators set out in the research plan |
| Endpoints appropriate to the aim of the study | 2 | Comments: The bone and tooth measurements in the outcome measures appropriately reflect the purpose of the study |
| Unbiased assessment of the study endpoint | 0 | Comments: The evaluation process of outcome indicators is not described |
| Follow-up period appropriate to the aim of the study | 2 | Comments: Patients in both groups were treated long enough, with the total duration of treatment lasting 1.3 ± 0.5 months |
| loss to follow-up less than 5% | 0 | Comments: As a retrospective study, no loss of follow-up was involved |
| Prospective calculation of the study size | 0 | Comment: The author did not estimate the sample size |
| An adequate control group | 2 | Comments: The setting of the control group fits the purpose of the study |
| Contemporary groups | 0 | Comments: As a retrospective study, the experimental group and the control group were not conducted at the same time |
| Baseline equivalence of groups | 1 | Comment: Before the experiment, the authors compared the experimental group with the control group, but did not give detailed data. Quote: “Thus, each patient in the treated group had a matched control from normative data with respect to age, sex and observation period.” |
| Adequate statistical analyses | 2 | Comment: The statistics match the type of study |
| Total | 15 | Medium |
| C̈irgić 201530 (RCT) | ||
| Random sequence generation | Unclear | Comment: Insufficient information to judge. |
| Allocation concealment | low | Quote: “ An informed written consent was obtained from the parents and randomization was performed by lottery.” |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | Unclear | Comment: Insufficient information to judge. |
| Incomplete outcome data addressed | low | Comments: Although there were missing data, the missing data was similar in the experimental group and the control group, and the missing amount was small enough to affect the final results. |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | low | Comments: No other bias was detected. |
| Sun 201821 (RCT) | ||
| Random sequence generation | Unclear | Comment: Insufficient information to judge. |
| Allocation concealment | Unclear | Comment: Insufficient information to judge. |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | Unclear | Comment: Insufficient information to judge. |
| Incomplete outcome data addressed | low | Comment: No data missing |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | High | Comments: The sample size was too small, only 20 cases, so other bias was considered high. |
| Idris 201922 (RCT) | ||
| Random sequence generation | low | Quote: “Sixty participants were selected randomly out of the 188 possible candidates using a computer-generated list of random numbers with the aid of SPSS.” |
| Allocation concealment | low | Quote: “Allocation concealment was performed using opaque sealed envelopes which contained the assigned group for each patient and were not opened till the onset of the trial.” |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | Unclear | Comment: Insufficient information to judge. |
| Incomplete outcome data addressed | low | Comments: Although there were missing data, the missing data was similar in the experimental group and the control group, and the missing amount was small enough to affect the final results. |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | low | Comments: No other bias was detected. |
| Elhamouly 202026 (RCT) | ||
| Random sequence generation | low | Quote: “The twenty children were randomly assigned in a 1:1 ratio using a computer-generated list of random numbers to one of the two groups.” |
| Allocation concealment | low | Quote: “An opaque envelope that was opened after seating the participant was used for allocation.” |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | low | Quote: “Two outcome assessors were blind to the appliance used during their evaluations of the X rays and the study models. Additionally, the statistician was blind to the appliances used in the group analysis.” |
| Incomplete outcome data addressed | High | Comments: There were two patients lost to follow-up in the experimental group and the control group, which reached 20% of the total number of cases. |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | low | Comments: No other bias was detected. |
| Hanoun 202023 (RCT) | ||
| Random sequence generation | low | Quote: “The prospective parallel design study involved a simple randomization using an online randomization tool.” |
| Allocation concealment | Unclear | Comment: Insufficient information to judge. |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | low | Quote: “The radiographs were re-coded so that the grouping and any identity were obscured to the investigators.” |
| Incomplete outcome data addressed | low | Comments: No subjects dropped out and data was missing. |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | low | Comments: No other bias was detected. |
| Ji 202027 (RCT) | ||
| Random sequence generation | Unclear | Comment: Insufficient information to judge. |
| Allocation concealment | Unclear | Comment: Insufficient information to judge. |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | Unclear | Comment: Insufficient information to judge |
| Incomplete outcome data addressed | low | Comment: No data missing. |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | low | Comments: No other bias was detected. |
| Xie 202019 (RCT) | ||
| Random sequence generation | Unclear | Comment: Insufficient information to judge. |
| Allocation concealment | Unclear | Comment: Insufficient information to judge. |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | Unclear | Comment: Insufficient information to judge. |
| Incomplete outcome data addressed | low | Comment: No data missing. |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | low | Comments: No other bias was detected. |
| Chen 202128 (NRS) | ||
| Aim of the study clear | 2 | Comments: The author gives a clear research purpose |
| Inclusion of consecutive patients | 2 | Comment: Patients who met the inclusion criteria were included during the study period |
| Prospective collection of data | 2 | Comments: The authors collected the indicators set out in the research plan |
| Endpoints appropriate to the aim of the study | 2 | Comments: The bone and tooth measurements in the outcome measures appropriately reflect the purpose of the study |
| Unbiased assessment of the study endpoint | 1 | Comments: Measured and evaluated by the author alone, which is too subjective. |
| Follow-up period appropriate to the aim of the study | 2 | Comments: The total duration of treatment in both groups lasted 10 to 12 months |
| Loss to follow-up less than 5% | 0 | Comments: As a retrospective study, no loss of follow-up was involved |
| Prospective calculation of the study size | 0 | Comment: The author did not estimate the sample size |
| An adequate control group | 2 | Comments: The setting of the control group fits the purpose of the study |
| Contemporary groups | 0 | Comments: As a retrospective study, the experimental group and the control group were not conducted at the same time |
| Baseline equivalence of groups | 0 | Comments: The authors did not describe the differences between the two groups before the trial began |
| Adequate statistical analyses | 2 | Comment: The statistics match the type of study |
| Total | 15 | Medium |
| Johnson 202131 (RCT) | ||
| Random sequence generation | Unclear | Comment: Insufficient information to judge. |
| Allocation concealment | Unclear | Comment: Insufficient information to judge. |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | Unclear | Comment: Insufficient information to judge. |
| Incomplete outcome data addressed | low | Comment: No data missing. |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | low | Comments: No other bias was detected. |
| Habumugisha 202224 (NRS) | ||
| Aim of the study clear | 2 | Comments: The author gives a clear research purpose |
| Inclusion of consecutive patients | 2 | Comment: Patients who met the inclusion criteria were included during the study period |
| Prospective collection of data | 2 | Comments: The authors collected the indicators set out in the research plan |
| Endpoints appropriate to the aim of the study | 2 | Comments: The bone and tooth measurements in the outcome measures appropriately reflect the purpose of the study |
| Unbiased assessment of the study endpoint | 2 | The cephalometric radiographs were analyzed by a calibrated investigator with Dolphin 11.5 The investigator was blinded to the information of patients. The landmarks of cephalometric radiographs are shown in Figure 2. |
| Ramirez-Yañez 200725 (NRS) | ||
| Follow-up period appropriate to the aim of the study | 2 | Comment: Follow-up time is enough Quote: “Our study lasted for 13.0 ± 1.1 months.” |
| loss to follow-up less than 5% | 0 | Comment: The study involved 224 patients and was completed by 204 patients. The loss of follow-up rate is higher than 5 percent. |
| Prospective calculation of the study size | 1 | Comment: The author mentions an estimate of sample size, but the information is insufficient |
| An adequate control group | 2 | Comments: The setting of the control group fits the purpose of the study |
| Contemporary groups | 2 | Comments: Control group and experimental group were conducted at the same time. |
| Baseline equivalence of groups | 2 | Quote: “There were no statistical differences in the average age, sex, ANB°, and SNA° among the three groups (P > 0.05).” |
| Adequate statistical analyses | 2 | Comment: The statistics match the type of study |
| Total | 21 | High |
| Çoban Büyükbayraktar and Camcı (2023)13 (NRS) | ||
| Aim of the study clear | 2 | Comment: The author gives a clear research purpose |
| Inclusion of consecutive patients | 2 | Comment: Patients who met the inclusion criteria were included during the study period |
| Prospective collection of data | 2 | Comment: The authors collected the indicators set out in the research plan |
| Endpoints appropriate to the aim of the study | 2 | Comment: The authors collected the indicators set out in the research plan |
| Unbiased assessment of the study endpoint | 2 | Quote:”A single investigator (H.C.) performed measure ments without knowing which group each x-ray belonged to.” |
| Follow-up period appropriate to the aim of the study | 2 | Comment: Follow-up time is enough Quote: “analyze the changes after one year of treatment.” |
| loss to follow-up less than 5% | 2 | Comment: There were no missing data according to the results |
| Prospective calculation of the study size | 2 | Quote:”Te sample size calculation using the G Power software revealed that at least 32 patients were required (efect size=0.8, α =0.05, and 1–β =0.90)” |
| An adequate control group | 2 | Comments: The setting of the control group fits the purpose of the study |
| Contemporary groups | 0 | Comment: As a retrospective study, the experimental group and the control group were not conducted at the same time |
| Baseline equivalence of groups | 0 | Comment: The authors did not describe the differences between the two groups before the trial began |
| Adequate statistical analyses | 2 | Comment: The statistics match the type of study |
| Total | 20 | High |
| Madian 202312 (RCT) | ||
| Random sequence generation | low | Quote: “Twenty-six children were randomly assigned in a 1:1 ratio using a computer-generated list of random numbers to one of the two groups.” |
| Allocation concealment | low | Quote: “When a patient was deemed as eligible for enrollment, the patient was assigned to a treatment group using opaque and sealed envelopes containing the allocation number.” |
| Blinding of participants and personnel | High | Comment: Blinding of participants and personnel is impossible. |
| Blinding of outcome assessment | low | Quote: “The researcher and the statistician who evaluated the data were blinded.” |
| Incomplete outcome data addressed | low | Comment: No data missing. |
| Free of selective reporting | low | Comments: The indicators selected by the authors for observation before the experiment were fully reported during the experiment. |
| Other Bias | low | Comments: No other bias was detected. |