Condition category
Not Applicable
Date applied
19/10/2017
Date assigned
02/11/2017
Last edited
02/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Grinding and clenching the teeth have been associated with joint pain, muscle pain, headaches and tooth wear. The symptoms are very common and often are present with awakening in the morning. A common treatment for jaw pain and headaches has been the construction of bite planes. However, bite plane therapy often fails to control the symptoms of headache and pain. The aim of this study is to use the concept of stretching the muscles that close the jaw in order to have the muscles relax and therefore, decrease the force of grinding and clenching at night time.

Who can participate?
Females aged 20-57 years old who grind or clench their teeth.

What does the study involve?
Participants are examined clinically, complete clinical histories, have impressions taken for fabrication of their bite planes, and have lateral cephalograms (x-rays of the side of the face) and panoramic radiographs (dental x-rays) taken. Participants undergo sleep studies before treatment and after treatment while wearing their new altered bite plane. Participants are assessed for their grinding and clenching level.

What are the possible benefits and risks of participating?
Participants may benefit from a reduction or illumination of their symptoms of pain and headache. There are no risks to any of the patients who have been recruited into the study as all have had biplanes in the past and have not responded to treatment.

Where is the study run from?
1. University Hospital London Health Sciences Centre (Canada)
2. Private office of Dr. Douglas Awde (Canada)

When is the study starting and how long is it expected to run for?
August 1999 to February 2001

Who is funding the study?
Investigator initiated and funded (Canada)

Who is the main contact?
Dr Douglas Awde
doug@adpcorp.ca

Trial website

Contact information

Type

Public

Primary contact

Dr Douglas Awde

ORCID ID

Contact details

University of Western Ontario
London
Ontario
N6H 4S4
Canada
+1 519 672 5456
doug@adpcorp.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pilot study of the effect of altered vertical dimension bite plane therapy on myofascial pain dysfunction and temporomandibular joint dysfunction

Acronym

Study hypothesis

The aim of this study is to determine whether the use of variable thickness bite planes would control parafunction in patients who had previously not responded to splint therapy.

Ethics approval

The University of Western Ontario Review Board of Health Sciences Research Involving Human Subject, 15/12/1999, ref: Review number: 7340

Study design

Single centre interventional study, evaluating the symptoms of TMD/MPD and the sleep patterns of 19 female patients with altered vertical dimension bite planes who had previously failed bite plane therapy.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

TMD, MPD, Sleep Stages

Intervention

Patients are examined clinically, complete clinical histories, have impressions taken for fabrication of mandibular Gelb bite planes, and have lateral cephalograms and panoramic radiographs taken. Participants undergo sleep studies prior to the start of treatment and after the treatment is completed wearing their new altered bite plane. Patients complete the TMJ Scale, the McGill pain questionnaire, the Epworth Sleepiness Scale, and the Helkimo Clinical Dysfunction Assessment. Bite planes are increased in thickness in a 4 week schedule if signs of parafunction are present on the splint and if symptoms are present.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. TMD symptoms are measured using the TMJ scale at baseline and study end
2. Bruxism is measured using the polysomnograph at baseline and study end
3. Daytime sleepiness is measured using Epworth Sleepiness Scale at baseline and study end
4. Pain symptoms with treatment is measured using the McGill pain questionnaire at baseline and study end
5. Patient symptoms are measured using the Helkimo Index at baseline and study end

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

01/08/1999

Overall trial end date

01/02/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Permanent dentitions with no more than 1 tooth missing per quadrant (excluding wisdom teeth)
2. No implants or partial dentures
3. Not undergoing current treatment for TMD/MPD
3. Females aged 20-57

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20 female patients

Participant exclusion criteria

1. Male
2. Children and seniors
3. Multiple missing teeth in each quadrant
4. Dental implants
5. Partial dentures
6. Active treatment for TAD/MPD

Recruitment start date

01/01/2000

Recruitment end date

01/06/2000

Locations

Countries of recruitment

Canada

Trial participating centre

University Hospital London Health Sciences Centre
339 Windmere Road
London, Ontario
N6A 505
Canada

Trial participating centre

Private office of Dr. Douglas Awde
525 Oxford Street East
London, Ontario
N5Y 3H8
Canada

Sponsor information

Organisation

Ontario Thoracic Society Block Term Grant

Sponsor details

401-18 Wynford Drive
Ontario
Toronto
M3C 0K8
Canada
+1 416 864 9911 ext. 254
ots@on.lung.ca

Sponsor type

Research organisation

Website

https://www.lungontario.ca/page.aspx?pid=421

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study will be submitted to the Journal of the American Dental Association, which is a prominent high impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Douglas Awde. E-mail: awdedouglas@gmail.com, please CC. doug@adpcorp.ca

Intention to publish date

01/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes