The aim of this study was to compare three treatment modalities ( splint therapy, physical therapy and combination of splint and physical therapy) in improving the painful temporo-mandibular joint clicking. A total of 54 patients with the diagnosis of Temporo-mandibular Disorder (TMD) were randomly assigned into physical therapy, splint therapy and splint-physical therapy groups. The patients in Physical therapy group (n=20) were treated by three modalities including ultrasound, TENS and exercise therapy every other day for 4 weeks. The patients in splint therapy group (n=20) received anterior positioning splint therapy for three month. Patients in splint-Physical therapy group (n=14) underwent both treatment consecutively. After the treatment, the patients were followed for a month. The primary outcome was pain according to VAS and the presence of temporo-mandibular joint clicking.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011205087N3
Registration date:2011-01-28, 1389/11/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-28, 1389/11/08
Registrant information
Name
Amirtaher Mirmortazavi
Name of organization / entity
Mashhad Dental School,department of Prosthodontics
Country
Iran (Islamic Republic of)
Phone
+98 51 1764 2126
Email address
mirmortazavia861@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Mashhad University of Medical Sciences
Expected recruitment start date
2007-12-31, 1386/10/10
Expected recruitment end date
2009-12-31, 1388/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of physical therapy and splint therapy in the management of painful clicking of temporomandibular joints
Public title
Comparison of three treatment options in the management of painful temporomandibular joint clicking: Randomised clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of permanent, painful and intermediate clicking
Exclusion criteria: Intracapsular clicking, history of sinus disease, migraine, neuralgia, arthritis, ear infection or TMJ trauma, Orthodontic treatment, consumption of sedative drugs, muscle relaxant, or psychoactive using
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi department, Daneshgah Ave, Mashhad
City
Mashhad
Postal code
Approval date
1990-01-01, 1368/10/11
Ethics committee reference number
1564
Health conditions studied
1
Description of health condition studied
Temporomandibular joint painful clicking
ICD-10 code
K07.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
temporomandibular joint pain
Timepoint
before treatment - during treatment- after treatment
Method of measurement
due to VAS , patient's statement
2
Description
presence of temporomandibular clicking
Timepoint
before treatment - after treatment
Method of measurement
hearing click sound
Secondary outcomes
empty
Intervention groups
1
Description
Splint therapy, at nights, use of anterior positioning appliance for 3 month
Category
Treatment - Other
2
Description
Physical therapy modalities including Ultrasound, TENS and exercise therapy in one hour appointments, alternate days for 4 weeks
Category
Treatment - Other
3
Description
Update February 16, 2011: Physical therapy modalities including Ultrasound, TENS and exercise therapy in one hour appointments, alternate days for 4 weeks as well as Splint therapy, at nights, use of anterior positioning appliance for 3 months
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Amirtaher Mirmortazavi
Street address
Mashhad Dental School, Vakilabad Ave
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohamad Ramezani
Street address
Ghoreishi department, Daneshgah Ave, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Mashhad University of Medical Sciences