Figure 1.
Study selection process.
Table I.
Characteristics of the included studies
| Study ID [reference] | Study Characteristics | Population characteristics | Intervention Details | Control Group | Outcomes measured | Tool / Instrument Used | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Authors, Year of Publication & Country | Study design & Sample size | Age Mean | Gender distribution | No of participants | Type of intervention | Duration of intervention | No of participants | Type of intervention | |||
| Aksakali 21512 | Aksakalli S. et al., 2015, Turkey | RCT 40 | 31 years. | 34 (75%) females & 6(25%) males | 20 | Stabilization splint | 3 months | 20 | Nociceptive trigeminal inhibition-tension suppression system | Pain, Oral health related quality of life & Change in patient complaints | Fonseca’s questionnaire, the Oral Health QoL-UK and visual analog scale. |
| Alajbeg 202013 | Alajbeg IZ. Et al., 2020, Croatia | RCT 34 | 36.l ± 11.95 years | xxxxx | 19 | Stabilization splint | 6 months | 15 | Placebo splint | Pain variables, Generalized anxiety & Depression, | Graded Chronic Pain Scale, Generalized anxiety disorder-7 questionnaire, Patient health questionnaire-9 |
| DeResend 201914 | Machado de Resende CM. et al., 2019, Brazil | RCT, 89 | 28 ± 9.34 years | 72 (80.9%) females & 17 (19.1%) males | 24 in occlusal splint & 21 in manual therapy group & 25 in oral splint and counselling group | Occlusal splint | 1 month | 19 | Counselling | Pain, Sleep quality, Quality of life & Oral health related quality of life. | Visual analog scale, Pittsburgh Sleep Quality Index questionnaire, World health organization quality of life questionnaire-BREF, The Oral Health Impact Profile-14 |
| Giancarlo 202115 | Canales GD. et al., 2021, Brazil | RCT, 100 | 36.8 ± 5.6 years | 100% females | 20 in Oral splint group & 60 in botulinum toxin group | Stabilization splint | 6 months | 20 | Normal saline injection | Pain intensity & Depression | The Graded Chronic Pain Scale, The Symptoms Checklist-9OR (SCL-DEP) |
| Guadalupe 201616 | Molina-Torres G. et al., 2016 Spain | RCT 58 | 51 ± 8 years | 94% females & 6% males | 29 | Stabilization splint | 12 weeks | 29 | Laser therapy | Intensity of pain, Severity of symptoms & Sleep quality | Visual analog scale, Symptom Severity Scale, Pittsburgh Sleep Quality Index Questionnaire |
| Hutela 202017 | Huhtela OS. et al. 2020, Finland | RCT 40 | 26 years, | 85% females & 15% males | 22 | Stabilization splint | 12 months | 18 | Applied relaxation method | Pain, Non-specific physical symptoms & Depression | Visual analog scale, Axis II questionnaire, |
| Kokkola 201818 | Kokkola O. et al., 2018, Finland | RCT 80 | 44.4 + 12.6 years | 82.5% females & 17.5% males | 39 | Stabilization splint | 12 months | 41 | Counselling | Oral health related quality of life | The Oral Health Impact Profile-14 |
| Layza 202419 | Oppitz LR. et al., 2024, Brazil. | RCT 43 | 34.8 ± 10.29 years | 32 (74.4%) females & 11(25.6%) males | 23 | Rigid stabilization splint | 12 months | 20 | Mixed splint | Orofacial pain, Quality of life. Anxiety & Depression | Visual analog scale, World health organization quality of life questionnaire-BREF, Hospital Anxiety and Depression Scale |
| Marijana 202120 | Gikic M. et al. 2021, Croatia | RCT 30 | 36.44 ± 10.51 years | 100% females | 10 | Stabilization splints | 6 months | 10 | Received thin thermoforming foil (Erkodent 0.5 mm) | Spontaneous pain, Pain intensity, Oral health related quality of life & Anxiety | Visual analog scale, Composite pain index Score, The Oral Health Impact Profile-14, Generalized anxiety disorder-7 questionnaire |
| Melo 202021 | Melo RA. et al., 2020, Brazil | RCT, 85 | 28 ± 9.34 years | 82% females & 18% males | 25 in oral splint and counselling group, 22 in Occlusal splint & 21 in manual therapy group | Occlusal splint | 30 days | 17 | Counselling | Pain & Anxiety | Visual analog scale, Hospital Anxiety and Depression Scale, The Beck Anxiety Inventory, The State-Trait Anxiety Inventory (STAI) questionnaire |
| Omer 202222 | Ekici O. et al., 2022, Turkey. | RCT 132 | Intervention group 28.58 ± 14.46 years Control group 29.47 ± 10.49 years | 31 (23.5%) males & 101 (76.5%) females | 34 | Occlusal splint | 12 weeks | 34 | No active treatment, Counselling. | Pain, Range of motion of the jaw, Disability & Quality of life | Visual analog scale, The Oral Health Impact Profile-14, Jaw Functional Limitation Scale. |
| Oz 2010 23 | Oz S. et al., 2010, Turkey | RCT, 40 | 32.84 ± 10.70 years | 34 (85%) females & 6 (15%) males | 20 | Occlusal splints | 3 months | 20 | Low dose laser therapy | Pain, Pressure pain threshold & Depression | Visual analog scale, RDC/TMD) Axis II criteria |
| Peixoto 202124 | Peixoto KO. et al., 2021, Brazil | RCT, 60 | 18-65 years | xxxx | 15 in occlusal splint, 15 in scalp Acupuncture & and 15 in manual therapy group | occlusal splint | 30 days | 15 | Counselling | Pain, Sleep & Quality of life | Visual analog scale, Pittsburgh Sleep Quality Index Questionnaire, World health organization quality of life questionnaire |
| Rodrigeus 201925 | Rodrigeus MF. et al., 2019 Brazil | RCT, 21 | Average age in intervention group 43.63 years & 47.5 years in control group | 100% females | 11 | Occlusal splints | 6 months | 10 | Low-power laser auriculotherapy | Pain, Degree of jaw functioning, Depression & Nonspecific physical symptoms | American Academy of Orofacial Pain questionnaire, Symptoms Checklist-90 (SCL-90) Depression Scale |
| Rossana 202426 | Izzetti R. et al., 2024, Italy | RCT, 1 20 | Intervention group 40.71 ± 15.85 years Control group 42.76 ± 16.94 years | 66 (55%) females & 54 (45%) males | 60 | Stabilization splint & physio-kinesiotherapy | 6 months | 60 | No intervention | Pain, Depression, Anxiety & Oral health related quality of life. | Pressure pain threshold scores, The Oral Health Impact Profile-14, Patient health questionnaire-9, Generalized anxiety disorder-7 questionnaire |
| Verbanovic 201927 | Vrbanovic E. et al., 2019 Croatia | RCT, 30 | Intervention group 38.89 ± 11.79 years Control group 32.66 ± 11.48 years | 100% females | 17 | Stabilization splint | 6 months | 13 | Placebo splint | Pain & Quality of life | Visual analog scale, The Oral Health Impact Profile-14 |
| Wanman 202028 | Wanman A. et al., 2020, Sweden | RCT, 90 | 39.2 ± 15.2 years | 63 (70%) females & 27 (30%) males | 30 in Bite splint and 30 in supervised exercise program. | Biite splint | 3 months | 30 | Home exercise therapy | Pain, Neck disability & Somatisation | Jaw function limitation scale-20, Neck Disability Index, Numeric pain rating scale 0-10 |
Figure 2.
Risk of bias graph.
Figure 3.
Risk of bias summary.
Figure 4.
Occlusal splint therapy effect on anxiety.
Figure 5.
Occlusal splint therapy effect on depression.
Figure 6.
Occlusal splint therapy effect on oral health-related quality of life.
Figure 7.
Occlusal splint therapy effect on sleep quality.
Table II.
Summary of the findings
| Sr. No. | Outcome | Effect size | P-value | Heterogeneity | Evidence Certainty (GRADE) |
|---|---|---|---|---|---|
| 1 | Anxiety | 0.05 (-0.49 to 0.60) | 0.85 | 74% (Moderate) | Low |
| 2 | Depression | -0.42 (-0.81 to -0.04) | 0.03 | 70% (Moderate) | Moderate |
| 3 | Oral Health-Related QoL | -0.14 (-0.78 to 0.50) | 0.67 | 88% (High) | Low |
| 4 | Sleep Quality | -0.54 (-1.22 to 0.14) | 0.12 | 71% (High) | Low |
| 5 | Overall QoL (General Component) | -0.07 (-0.59 to 0.46) | 0.80 | 48% (Moderate) | Moderate |
| 6 | Overall QoL (Physical Component) | 0.24 (-0.12 to 0.60) | 0.20 | 0% (Low) | Moderate |
| 7 | Overall QoL (Psychological Component) | -0.18 (-0.53 to 0.18) | 0.33 | 0% (Low) | Moderate |
| 8 | Overall QoL (Social Component) | 0.16 (-0.23 to 0.55) | 0.43 | 10% (Low) | Moderate |
| 9 | Overall QoL (Environmental Component) | -0.05 (-0.50 to 0.40) | 0.82 | 35% (Moderate) | Moderate |