Restoring Masticatory Function to Treat Chronic Pain

NCT02144233 | Terminated Results DMC

• 3 other identifiers: U1111-1134-0832PI11/02507ISRCTN
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

The primary endpoint will be the average change in pain score from baseline to the three- and six-month assessments. Efficacy will be demonstrated by superior pain relief with the active treatment compared with the placebo.

Conditions

Temporomandibular Joint Dysfunction Syndrome; Chronic Pain

Keywords

Pain; Temporomandibular joint disorders; Occlusal adjustment; Therapy; Randomized clinical trial; Mastication; Habitual chewing side; Handedness preference; Jaw asymmetry

Outcome Measures

Primary Outcomes (1)

• Jaw-pain-Intensity (Affected Side)

  Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.

  Baseline and 6-months

Secondary Outcomes (3)

• Chewing Side

  Baseline and 6-months

• Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R))

  Baseline, 6-Months

• Maximum Unassisted Jaw Opening

  Baseline, 3- and 6-Months

Other Outcomes (20)

• Headache-intensity

  Baseline 3- and 6-Months

• Number of Participants With Neuropathic Pain

  Baseline, 6-Months

• Handedness Preference

  Baseline

Study Arms (2)

Occlusal adjustment therapy

EXPERIMENTAL

Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness.

Procedure: Occlusal adjustment

Placebo occlusal adjustment therapy

PLACEBO COMPARATOR

Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.

Procedure: Placebo occlusal adjustment

Interventions

Occlusal adjustment PROCEDURE

The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)

Also known as: Occlusal reshaping, Selective grinding of teeth, Restoring physiological jaw-closure, Restoring impaired chewing function

Occlusal adjustment therapy

Placebo occlusal adjustment PROCEDURE

Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.

Placebo occlusal adjustment therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely dentate (except for the third molars; including if they were treated before enrollment by conventional or implant-supported fixed prosthesis allowing similar potential comfortable chewing on both sides)
• Normal Angle Class I occlusion
• Self-reported pain-intensity scores from 4 to 9 in a 0-10 visual analogue scale (VAS) or numerical pain rating scale (NRS).
• Chronic (over 6 months) joint and/or muscle pain, according to diagnostic criteria for temporomandibular disorders (DC/TMD), for which they had requested therapy

You may not qualify if:

• Psychosis
• Major depression
• Substance abuse
• Cognitive impairment
• Addiction to morphine or derivates
• Litigation or asking for disability/retirement compensation for chronic pain
• Dental care professionals
• Orthodontic therapy during the last 2 years
• Patients with any pain that is more severe, in the same location as, or cannot be clearly distinguished from TMD pain
• Individuals for whom minimally invasive occlusal adjustment could not achieve occlusal equilibration, including: Over 2 mm of difference between the maximal intercuspal position and the centric occlusion or over 4 mm of difference between upper and lower archs (or over 2mm on at less one side) measured: between the mesial fosses of first upper premolars with respect the buccal cusps of the first lower premolars; and/or between the mesiopalatal cusp of the first upper molars respect to the central (mesial) fossae of the first lower molar.
• Severe periodontal disease with grade 3 mobility

Sponsors & Collaborators

• Urbano Santana Penin, MD, DDS, PhD: lead
• University of Santiago de Compostela: collaborator

Study Sites (2)

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, Galicia, 15782, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña. Galicia, 15006, Spain

Location

Related Publications (1)

• Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013.

  PMID: 23593156 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome; Chronic Pain; Pain; Temporomandibular Joint Disorders

Interventions

Occlusal Adjustment

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Results Point of Contact

• Title: Professor Urbano Santana Penín
• Organization: University of Santiago de Compostela. A Coruña. SPAIN

urbano.santana@usc.es

+34647344093

Study Officials

• Urbano Santana-Penin, Prof

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

• Jose Lopez-Cedrun, Dr

  University Hospital Complex of La Coruña

  STUDY CHAIR

• Maria J Mora, Prof

  University of Santiago de Compostela

  STUDY DIRECTOR

• Urbano Santana-Mora, Dr

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: August 1, 2014
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: April 22, 2020
• Results First Posted: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The raw data of each participant, unidentifiable, will be accessible within 6 months after the publication of the manuscript and will be accessible for at least one year.
• Access Criteria: Free access

Locations

ES (2)