UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042685 |
|---|---|
| Receipt number | R000048708 |
| Scientific Title | Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial |
| Date of disclosure of the study information | 2020/12/08 |
| Last modified on | 2021/06/30 15:04:38 |
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Basic information
Public title
Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial
Acronym
Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial
Scientific Title
Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial
Scientific Title:Acronym
Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial
Region
| Asia(except Japan) |
Condition
Condition
Temporomandibular Disorder
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of muscle energy technique on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months
To determine the effects of Occlusal splint Therapy on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months
To determine the effects of Muscle Energy Technique + Occlusal splint therapy (Combined treatment) on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months
To determine the effects of education for self-managemen, and counselling on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months
To compare the effects of Muscle Energy Technique, Occlusal splint Therapy, Combined treatment and Education for self-management and counselling (control group)on the intensity of pain and maximum mouth opening in patients with TMD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intensity of pain on visual analogue scale at baseline, after 1 week, after 2 weeks, after 1 month and after 3 months
Key secondary outcomes
Maximum mouth opening at baseline, after 1 week, after 2 weeks, after 1 month and after 3 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
| Other |
Interventions/Control_1
Muscle Energy Technique(30 min session for three days a week for four weeks) + Education for self-management, and counselling
Interventions/Control_2
Occlusal splint therapy + Education for self-management and counselling for three months
Interventions/Control_3
Muscle energy technique(30 min session for three days a week for four weeks) + Occlusal splint therapy (for three months) in addition to education for self-managementand counselling
Interventions/Control_4
Education for self-management and counselling alone for one month
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Pain in TMJ, Muscles of mastication or both, 2)Reduced mouth opening including the verticle overlap of <40mm,3) Symptoms present for> 4 weeks
Key exclusion criteria
1) patients under treatment of analgesics,muscle relaxants and anti depressants,2)Abscence of upper and/or lower central incisor,3)Presence of complete or removable partial prostheses with distal extension,4)patients who received orthodontic treatment in the past,5)patients with oral submucous fibrosis,6)Patients who were unable to attend the Hospital for the Prescribed treatment period,7)The Patient who insisted on for a specific treatment (e.g. occlusal adjustments, medication),8)Patients with Malignant tumours of the face and jaw,9)History of fracture or surgery of jaw or TMJ,10)Patients who had received any form of treatment for TMD in past,
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Dr Hardik |
| Middle name | Keshubhai |
| Last name | Ram |
Organization
Ahmedabad Dental College & Hospital
Division name
Dept. of Prosthodontics
Zip code
382115
Address
Bhadaj-Ranchhodpura road,Nr. Science city, Ta:- Kalol, Dist:- Gandhinagar, 382115
TEL
9879779994
drhkram@gmail.com
Public contact
Name of contact person
| 1st name | Dr Hardik |
| Middle name | Keshubhai |
| Last name | Ram |
Organization
Ahmedabad Dental College & hospital
Division name
Dept. Of Prosthodontics
Zip code
362220
Address
P.M Park, Barsana Society, Mangarol Road, Keshod-362220
TEL
9879779994
Homepage URL
drhkram@gmail.com
Sponsor or person
Institute
Ahmedabad Dental College & Hospital
Dept. Of Prosthodontics
Bhadaj-Ranchhodpura road, Santej, Nr. Science city, Ta:- Kalol, Dist:- Gandhinagar
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Indian
Other related organizations
Co-sponsor
self
Name of secondary funder(s)
self
IRB Contact (For public release)
Organization
Ahmedabad Dental College & Hospital
Address
Bhadaj-Ranchhodpura road, Santej, Nr. Science city, Ta:- Kalol, Dist:- Gandhinagar
Tel
02764-260447
info@adc.org.in
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Ahmedabad Dental College & Hospital, AMC Dental College & Hospital, Siddhpur Dental College & Hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
160
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Covid -19
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 12 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 12 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 08 | Day |
Last modified on
| 2021 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048708
