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Occlusal Adjustment as Treatment for Chronic Orofacial Pain

U

University of Santiago de Compostela

Status and phase

Completed
Phase 2
Phase 1

Conditions

Temporomandibular Joint Disorders
Orofacial Pain

Treatments

Procedure: Placebo occlusal adjustment
Procedure: Occlusal adjustment

Study type

Interventional

Funder types

Other

Identifiers

NCT00899717
2009/017

Details and patient eligibility

About

The purpose of this study is to determine whether occlusal adjustment by selective grinding and/or occlusal addition is an effective treatment of chronic temporomandibular joint disorders.

Full description

Temporomandibular disorders (TMD) are very common disorders in daily dentistry and oral and maxillofacial practice. The key symptoms are jaw joint pain and limited mouth opening. Other than trauma, the causes remain unknown; consequently, there are no treatments based on specific etiologies. In our experience, patients can usually receive beneficial occlusal adjustments if these are carefully planned and performed in two steps: (1) elimination of premature contacts, which reduces loads in the temporomandibular joints, and (2) individualized remodeling of lateral anterior guidance to facilitate unilateral alternate chewing. The study will use stratified blocking randomization to blindly assign patients to the real or placebo treatment groups in order to evaluate the null hypothesis (H0) that "Occlusal adjustment of sufficient quality has no effect on chronic pain and/or limited mouth opening in TMD patients."

Enrollment

21 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • People suitable for inclusion in the study are full dentate patients
  • Aged between 18 and 65 years
  • Patients with chronic TMD pain (and usually with associated limited mouth opening) for whom occlusal adjustment could achieve normal occlusion, both static and functionally equilibrated

Exclusion criteria

  • Pregnancy
  • Trauma
  • Previous TMJ surgery
  • Patient refusal to consent to participate in the study or significant concerns about the study
  • Limited collaboration
  • Concurrent active treatment with orthodontics, and active periodontal disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

21 participants in 2 patient groups, including a placebo group

A
Experimental group
Treatment:
Procedure: Occlusal adjustment
B
Placebo Comparator group
Treatment:
Procedure: Placebo occlusal adjustment

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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