NCT00899717

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 16, 2013

Completed
Last Updated

July 26, 2013

Status Verified

July 1, 2013

Enrollment Period

1 month

First QC Date

May 11, 2009

Results QC Date

April 10, 2013

Last Update Submit

July 21, 2013

Conditions

Temporomandibular Joint DisordersOrofacial Pain

Keywords

Temporomandibular Joint Disorders (TMD)Orofacial painLimited mouth openingCraniomandibular dysfunction syndromeAxiographyGnatographyPreferred chewing sideOcclusal adjustmentSelective grindingHandednessBruxismTMDCosten's SyndromeMyofascial painTMD treatmentPain

Outcome Measures

Primary Outcomes (1)

  • Visual Analogic Scale for Pain Intensity (0-10)

    The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0="No pain" and 10="Worst imaginable pain"

    Baseline, immediately after therapy, 3 months and 6 months after therapy

Secondary Outcomes (4)

  • Symptom Checklist-90-Revised (SCL-90-R®)

    Before and 6 months after therapy

  • Preferred Chewing Side

    Before and 6 months after therapy

  • Maximum Mouth Opening (mm)

    6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up

  • Condylar Path Angles

    Baseline

Study Arms (2)

A

EXPERIMENTAL
Procedure: Occlusal adjustment

B

PLACEBO COMPARATOR
Procedure: Placebo occlusal adjustment

Interventions

Occlusal adjustmentPROCEDURE

modification of occlusal surfaces

Also known as: Selective grinding, Occlusal reshaping, Occlusal equilibration, Occlusal therapy
A
Placebo occlusal adjustmentPROCEDURE

Simulated modification of occlusal surfaces

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Complejo Hospitalario Universitario de La Coruña

A Coruña, La Coruña, 15006, Spain

Location

Facultad de Medicina y Odontología

Santiago de Compostela, La Coruña, 15782, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersFacial PainBruxismTemporomandibular Joint Dysfunction SyndromePain

Interventions

Occlusal Adjustment

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesHabitsBehaviorMyofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Orthodontics, CorrectiveOrthodonticsDentistry

Results Point of Contact

Title
Urbano Santana Penín
Organization
University of Santiago de Compostela
urbano.santana@usc.es
0034647344093

Study Officials

  • José López-Cedrún Cembranos, MD, DDS, PhD

    Complejo Hospitalario Universitario de La Coruña

    PRINCIPAL INVESTIGATOR

  • Urbano Santana Penín, MD, DDS, PhD

    Universidad de Santiago de Compostela

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

April 1, 2010

Last Updated

July 26, 2013

Results First Posted

July 16, 2013

Record last verified: 2013-07

Locations

ES(2)