UMIN-CTR Clinical Trial

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
Email	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
Email	drhkram@gmail.com

Sponsor
Institute	Ahmedabad Dental College & Hospital Dept. Of Prosthodontics Bhadaj-Ranchhodpura road, Santej, Nr. Science city, Ta:- Kalol, Dist:- Gandhinagar
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048708