Improving chewing function to treat chronic pain
| ISRCTN | ISRCTN61654487 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61654487 |
| ClinicalTrials.gov (NCT) | NCT02144233 |
| Protocol serial number | UTN: U1111-1134-0832 |
| Sponsor | University of Santiago de Compostela (Universidad de Santiago de Compostela) (Spain) |
| Funder | Ministerio de Ciencia e Innovación (Grant no. PI11/02507) |
- Submission date
- 03/07/2014
- Registration date
- 22/07/2014
- Last edited
- 17/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
The cause of long-term disorders of the jaw joint called chronic temporomandibular joint disorders (TMD) is unknown and therapy is usually not predictable. Because the risk factors for TMD include contact between teeth that hinders normal movement and habitual chewing on the affected side, this study attempts to find out the effect of the therapy in restoring jaw closure and improving chewing.
Who can participate?
Adults age 18-65 with TMD who are suffering from pain can take part in this study.
What does the study involve?
Patients will be randomly allocated to one of two groups: active therapy and placebo (dummy treatment). Patients allocated to the active therapy group will have their premature teeth contact rectified. Patients allocated to the placebo group will be subjected to a similar procedure but tooth enamel will not be removed.
What are the possible benefits and risks of participating?
The benefits are that the therapy could completely eliminate or reduce pain and/or help with alteration of limited mouth opening. It may help the joint return to its normal position (not always achieved) and to prevent an increase in joint, muscular and dental damage. The only risk or inconvenience appear to be from the grinding down of the enamel, which is irreversible. Hypersensitivity could occur during the treatment. If this were to occur, your treatment would be stopped immediately. This may mean that you would not be able to eat vigorously, which is what is hoped for, the treatment could therefore be ineffective.
Where is the study run from?
University of Santiago de Compostela (Universidad de Santiago de Compostela) (Spain)
When is the study starting and how long is it expected to run for?
July 2014 to June 2016
Who is funding the study?
Ministry of Science and Innovation of the Government of Spain
Who is the main contact?
Prof Urbano Santana-Penin
urbano.santana@usc.es
Contact information
Scientific
Universidad de Santiago de Compostela
Facultad de Medicina y Odontología
C/ Entrerrios s/n
Santiago de Compostela
15782
Spain
 ORCID ID |
0000-0002-9322-4120 |
|---|---|
| Phone | +34 (0)647 344 093 |
| urbano.santana@usc.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-centre, randomized, single-blind, blinded assessment, placebo-controlled, open-label, controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Restoring physiological jaw closure and MAsticatory function as treatment for chronic Pain: a randomized clinical trial |
| Study acronym | MAP |
| Study objectives | Current hypothesis as of 04/05/2016: That the restoration of physiological jaw closure and impaired chewing function by occlusal adjustment therapy will relieve chronic TMD-pain. Efficacy will be demonstrated by showing significantly superior pain relief at the 6-month visit with active treatment as compared with placebo. Previous hypothesis: The primary endpoint will be the average change in pain score from baseline to the 3- and 6-months assessments. Efficacy will be demonstrated by superior pain relief with the active treatment compared with the placebo. |
| Ethics approval(s) | Autonomic Committee of the Research Ethics of Galicia, updated on 29/11/2013, CAEI approval number 2009/017 |
| Health condition(s) or problem(s) studied | Facial pain: Chronic temporomandibular joint (TMJ) disorders (TMD) |
| Intervention | Active therapy will consist of the elimination of premature tooth contacts and the reduction of the steeper lateral anterior guidance. Placebo therapy will be conducted in a manner identical to the active adjustment, but no enamel will be removed. Added 09/05/2016: Interim analysis plan and stopping rules: The Data and Safety Monitoring Board will be responsible for activating early stopping. The study will employ an interim analysis plan with a single interim analysis after 70% of participants have completed the six-month follow-up visit. Using the Lan-DeMets version of the O'Brien-Fleming stopping rule, the critical value for statistical significance at the interim analysis (under intention-to-treat approach) will be +2.438, corresponding to a nominal two-sided P value of 0.0146. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Current primary outcome measures as of 04/05/2016: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 04/05/2016: |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 110 |
| Total final enrolment | 21 |
| Key inclusion criteria | Current inclusion criteria as of 04/05/2016: 1. Pre-screened patients satisfying the TMD-pain instrument (Gonzalez et al., 2011); TMD-pain diagnosis requires each of two findings: pain of sufficient frequency across a recent period and modification of the pain by jaw function. Assessors (JLC, FLF, MPC) will apply this instrument for eligibility 2. Patients suffering self-reported significant chronic TMD-pain (Joint and/or Muscle pain) according to DC/TMD (Schiffman et al., 2014) 3. Aged 18–65 years 4. Completely dentate adults with normal (or adequately restored with fixed crowns or bridges) occlusion 5. Suffering from significant TMD-pain (≥4 and ≤9 scores, in a 0–10 visual and/or numerical analogue scale-VAS/NRS; 0 = no pain to 10 = worst possible pain) 6. Had requested therapy for TMD-pain, referred to the Hospital/University Service 7. After more than 6 months of treatment with conservative therapies Previous inclusion criteria: TMD patients, aged 18-65 years with full dentates and normo-occlusion suffering significant pain (pain scores ≥4 and ≤9; method: visual analogue scale (VAS); 0 = no pain, 10 = worst imaginable pain) |
| Key exclusion criteria | Current exclusion criteria as of 04/05/2016: 1. Psychosis 2. Major depression 3. Substance abuse 4. Cognitive impairment 5. Addiction to morphine or derivatives 6. Litigation or asking for disability/retirement compensation for chronic pain 7. Dental care professionals 8. Orthodontic therapy during the last 2 years 9. Degree 2 to 3 of tooth mobility 10. Patients with any pain that is more severe, in the same location as, or cannot be clearly distinguished from TMD pain 11. Individuals for whom minimally-invasive occlusal adjustment could not achieve occlusal equilibration (assessed by the experts in occlusion, Drs. USM, MJM), to minimize tissue removal. Over 2 mm of difference between the maximal intercuspal position and the centric occlusion; and/or over 4 mm (2 mm on any side) of difference between upper and lower arches measured: between the mesial fossae of the first upper premolars with respect to the cusps of the first lower premolars; and the mesiopalatal cusp of the first upper molars with respect to the central fossae of the first lower molars. A Boley gauge (Beerendonk, nº REF 042-750-00; Dentaurum GmbH & Co., KG, Ispringen, Germany) will be used for these intraoral measurements 12. No periodontal disease (except for chronic severe cases with grade 2–3 mobility), fibromyalgia nor neuropathic pains are exclusion criteria Previous exclusion criteria: Main exclusion criterion is the requirement of excessive enamel removal to equilibrate the dental articulation (occlusion) |
| Date of first enrolment | 11/08/2014 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- Spain
Study participating centres
Santiago de Compostela
15782
Spain
A Coruña
15006
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/04/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/04/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
04/05/2016: the following changes were made to the trial record:
1. The overall trial start date was changed from 15/07/2014 to 03/07/2014.
2. The overall trial end date was changed from 31/12/2015 to 30/06/2017.
3. The public title was changed from 'Occlusal adjustment therapy for chronic facial pain' to 'Improving chewing function to treat chronic pain'
4. The study design was changed from 'Phase III, randomised, single (extensible to up three) centre, 6-month parallel-group, patient- and observer-blinded, placebo-controlled clinical trial' to 'Interventional single-centre, randomized, single-blind, blinded assessment, placebo-controlled, open-label, controlled study.'
