Control of parafunction with bite plane therapy
| ISRCTN | ISRCTN26019919 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26019919 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/10/2017
- Registration date
- 02/11/2017
- Last edited
- 01/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Public
University of Western Ontario
London, Ontario
N6H 4S4
Canada
| Phone | +1 519 672 5456 |
|---|---|
| doug@adpcorp.ca |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN26019919_PIS_01Nov17.docx |
| Scientific title | Pilot study of the effect of altered vertical dimension bite plane therapy on myofascial pain dysfunction and temporomandibular joint dysfunction |
| Study objectives | 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(s) | The University of Western Ontario Review Board of Health Sciences Research Involving Human Subject, 15/12/1999, ref: Review number: 7340 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/08/1999 |
| Completion date | 01/02/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 20 female patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/06/2000 |
Locations
Countries of recruitment
- Canada
Study participating centres
London, Ontario
N6A 505
Canada
London, Ontario
N5Y 3H8
Canada
Sponsor information
Research organisation
401-18 Wynford Drive
Ontario
Toronto
M3C 0K8
Canada
| Phone | +1 416 864 9911 ext. 254 |
|---|---|
| ots@on.lung.ca | |
| Website | https://www.lungontario.ca/page.aspx?pid=421 |
"ROR" |
https://ror.org/02pwbvs75 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/11/2017 | 01/04/2019 | No | Yes |
Additional files
- ISRCTN26019919_PIS_01Nov17.docx
- Uploaded 01/04/2019
Editorial Notes
01/04/2019: The participant information sheet has been uploaded.
