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Dental Medicine and Oral Health Sciences

Stabilization appliance therapy can be helpful in reducing pain associated with temporomandibular joint disorders

Clinical Question: Among the adult population with chronic symptomatic temporomandibular disorder, to what extent does the use of oral splints reduce symptoms of TMJ disorders (such as pain or discomfort) compared to no splints and/or alternative therapies (e.g., self-care TMJ instructions, physiotherapy) over a period of 6-12 months?

Clinical Bottom Line: Two systematic reviews have provided moderate quality evidence concluding that splint therapy may be effective in pain reduction in symptomatic TMJD patients compared to no/minimal treatment or alternative treatments. The studies included the comparison of interest and this evidence may be applicable to the Canadian population setting. The results are clinically meaningful but the clinical and statistical precision were compromised. The evidence quality was compromised by selection and performance bias of individual studies, small sample sizes, variation in splint designs and materials, variation in measurement outcomes and instruments, and variation in follow up time. Therefore, well designed and adequately powered studies - with clear methodologies based on the reliable and valid diagnostic criteria and classification for TMJDs - that assess additional clinically important outcomes (e.g. ‘improvement in function’) are needed.

Evidence Search:
("Temporomandibular Joint Disorders"[Mesh] OR "Temporomandibular Joint"[Mesh] OR temporomandibular joint disorder [tiab] OR TMD[tiab] OR TMJ[tiab] OR TMJD[tiab]) AND ("Occlusal Splints"[Mesh] OR nightguard[tiab] or nightguards[tiab] OR occlusal appliance[tiab] OR oral splints[tiab] or occlusal splints[tiab] or intraoral orthopedic[tiab]).  Limits applied: Systematic Reviews; Randomized Controlled Trials

Search date: November 13th, 2019

Additional search: TRIP Data Base; CATs Texas U.; ADA; J Oral Surg, J Oral Med, J Oral Pathol, J Oral Radiol

Author, year Source of evidence Population Characteristics Methods

1. Ebrahim  et al., 2012

PMID: 22855899

Systematic Review and Meta-analysis

(11 Randomized Control Trials)

Population: adults with temporomandibular disorders aged 29-51 years (age is not reported in some studies).

Sample size, total:  n = 455 (ranging from 20 to 76 participants per trial).

Location/Setting: Universities in Sweden (five studies), US (two studies), Jordan, Germany, Italy.

 

Search: MEDLINE, Embase, The Cochrane Central Register for Controlled Trials

Intervention: splint therapy

Control: minimal/no treatment in reducing pain

Primary Outcome: pain reduction in the temporomandibular joint (TMJ) area

Follow up: Ranged from 6.7 weeks to 12 months

Measurements: palpatory tests, pain during function, headaches, pain severity scale (VAS), pressure algometer score, temporomandibular muscle index

 

Key Results

Total 1,567 evidence sources, 70 articles retrieved in full text, 11 RCTs selected related to pain reduction outcome, publication years ranged from 1995 to 2010. Two RCTs measured Quality of Life outcome and two RCTs measured depression. SMD (Pain) = −0.93; 95% CI, −1.33 to −0.53; I2 = 47%. Natural units, 100-mm VAS scale (pain reduction) = − 11.5 mm (95% CI,− 16.5 mm to − 6.6 mm). RD  =  -0.35; 95% CI − 0.21 to − 0.46.  SMD (Quality of Life) = −0.09; 95% CI, −0.51 to 0.32; SMD (Depression) = −0.20; 95 % CI, −1.75 to 1.35.

Evidence Quality

Participants who received splint therapy had 35% less chance of having continued pain compared to the participants who received minimal/no treatment in reducing pain over a period of 6.7 weeks to 12 months. The results are statistically significant, clinically meaningful (20% threshold) and clinically precise. There were no significant differences between the splint therapy and control groups in terms of quality of life or depression outcomes.

Strengths: strong SR methodology: clear research question, eligibility criteria, librarian involved, three databases, two reviewers worked independently, no language restriction, PRISMA diagram, RCT study designs, modified Cochrane risk-of-bias tool, GRADE quality rating system, meta-analysis, focus on patient-important outcomes measured by validated instruments, no serious inconsistency/ indirectness/imprecision of the results, undetected publication bias, the research group studied reasons for heterogeneity.

Limitations: no mention of grey literature/citation tracking, no formal search strategy reported; included studies: minimal demographics and SES information, different splint designs, variation in measurement outcomes and instruments (which are not always validated), variation in follow up time, lack of reporting allocation concealment and masking of personnel, small sample sizes.

Perspectives: more studies needed with rigorous methodology and adequately powered, appropriate classification for TMJ disorders, add clinically important outcome ‘improvement in function’.

 

Author, year Source of evidence Population Characteristics Methods

2. Fricton et al., 2010.

PMID:
20664825

 

Systematic Review and Meta-analysis

(10 Randomized Control Trials)

Population: Predominantly female (87% based on the 9 accessible studies) patients with TMJ disorders and tension-type headaches, age range: 13– 76 years (of the 8 accessible studies which provided age).

Sample size:
Hard stabilization appliances vs palatal non-occluding appliances: n=385 (ranging from 28 to 90 participants per trial)
Stabilization appliances vs no treatment: n = 216 (ranging from 51 to 110 participants per trial)

Location/Setting: Universities and private practices in Canada (1 study), Sweden (4 studies), United States of America (2 studies), England (1 study) and Brazil (1 study) (of the 8 accessible studies which provided location).

Search: MEDLINE, The Cochrane Central Register for Controlled Trials, references.

Intervention: Intraoral stabilization appliances (splint therapy)

Control: non-occluding appliance for TMJD/no treatment/acupuncture/other

Primary Outcome: pain reduction

Follow up: Ranged from 7 days to 12 months

Measurements:  joint sounds, pain, limited opening, percent improved, reduction in migraines, subjective symptoms, MRI-TMJ disc recapture, range of motion, comfort, global improvement, etc.

 

Key Results

Total 55 RCTs of intraoral appliances for TMD; 44 RCTs were included in the systematic review; 10 RCTs were included in meta-analyses. Publication years: 1992 to 2006.
OR (stabilization appliances vs non-occluding appliances, 7 RCTs) = 2.45 (95% CIs 1.56 to 3.86).  OR (stabilization appliances vs no treatment, 3 RCTs) = 2.14 (95% CI 0.80 to 5.75).

Evidence Comments

RD = 14.5% (95% CI 5.6%, 28.6%). The subjects who received stabilization appliances had 14.5 % more pain reduction events than the subjects who received non-occluding appliances within a follow up ranged from 7 days to 12 months. The results are statistically significant, clinically meaningful (10% threshold) but not clinically precise.

RD = 11.4% (95% CI -2%, 47.5%). The subjects received stabilization appliances had 11.5 % more pain reduction events than the subjects who received no intervention within a follow up of 6 weeks to a year. The results are not statistically significant and not clinically precise.

Strengths: clear research question, clear eligibility criteria, 3 databases, MeSH terms and key words, 2 reviewers worked independently plus arbitrator(s), QUARUM approach, patient-important outcomes, CONSORT criteria and Cochrane handbook used for studies quality assessment, meta-analysis, minimal publication bias (funnel plots and Egger statistics).

Limitations: no grey literature search, English language only, minimal demographics and SES information, individual studies: 6 out of 10 included RCTs did not meet minimum level I criteria for minimising research bias, i.e. had selection/measurement/performance/attrition bias, the appliances varied in their designs and applications, variation in the controls and the outcomes measured, small sample sizes.

Applicability

The investigated population reflects the Canadian population of interest (teens and adults) with TMJD. It is feasible to provide oral splints in the Canadian setting as we have the resources available to fabricate them: laboratories and practicing dentists to make the appropriate adjustments. The SR studies included comparison of interest - either no treatment or alternative therapies, such as acupuncture or non-occluding appliances. The outcome of interest (reduction in pain, a patient-important outcome) was considered in all of the studies. Other patient-important outcomes, such as depressive symptoms and quality of life were considered in some studies. Time to follow up in most of the studies fit within the range of 6-12 months. The cost of an oral splint fabricated by a dental laboratory and adjusted by a dentist in Canada is approximately $600. Considering the benefit of potential reduction in pain, the cost of the splint is justifiable for a patient with symptomatic TMJD. Benefits of treatment include symptom reduction, conservative treatment, no subsequent intervention needed if treatment successful, long-term durability of appliances and additional oral health benefits such as prevention of attrition, incisal chipping, etc. Disadvantages of treatment include cost, partial or no response, possible patient discomfort and follow-up appointments for adjustment. However, there is a need for more research and robust evidence in order to make a final decision about the application of the studies’ results in clinical practice.

Authors: Rachel Korman, Mariana Capretz, Maryam Tarar, Georgina Lamontagne (DMD3 students)

Faculty mentor(s): Dr. F. Samim, Dr. S. Madathil, Dr. S. Tikhonova

Acknowledgments: Martin Morris (McGill librarian)

Date: March 30th, 2020 

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