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CTRI Number  CTRI/2025/09/094605 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study in people with jaw joint problems to see if gentle muscle treatment, breathing and exercise can improve pain, jaw function and facial appearance 
Scientific Title of Study   Functional Aesthetic Therapy Integrating Cranio-Cervical Soft Tissue Manipulation, Myofunctional Exercises, Lymphatic Drainage, and Postural Breathing for Facial Glow, Orofacial Alignment, Pain Reduction, and Improved Oral Function in Patients with Temporomandibular Disorders: A Patient-Reported Outcome Randomized Controlled Trial 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Chandra Patra 
Designation  Professor 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Block 3, Room no 105, Department of Physiotherapy.

Kapurthala
PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  ramesh.19500@lpu.co.in  
 
Details of Contact Person
Scientific Query  
Name  Mohammad Sarfraz 
Designation  PG Student 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Block 4, Room no 105

Kapurthala
PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  rafiqsarfroz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Chandra Patra 
Designation  Professor 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Uni-Hospital Department of Physiotherapy, Block 3, Room no 105. Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, PIN-144411

Kapurthala
PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  ramesh.19500@lpu.co.in  
 
Source of Monetary or Material Support  
NILL 
 
Primary Sponsor  
Name  Dr Ramesh Chandra Patra 
Address  Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Block 4, Room no 105 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nill   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh Chandra Patra  Dr Ramesh Chandra Patra  Uni-Hospital, Room no-105, Block-3 Department of Physiotherapy, Division of applied medical science, Lovely Professional University
Kapurthala
PUNJAB 		 09653174563

ramesh.19500@lpu.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M279||Disease of jaws, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Functional Aesthetic Therapy  Cranio-cervical soft tissue manipulation (10 minutes): Gentle manual therapy targeting cervical paraspinal muscles, suboccipital region, sternocleidomastoid, trapezius, and associated fascia to improve posture, alignment, and reduce referred pain. Orofacial myofunctional therapy (10 minutes): Targeted jaw and tongue exercises to optimize oral function. Facial lymphatic drainage and glow enhancement techniques (5 minutes): Gentle drainage to promote circulation and reduce puffiness. Postural and breathing exercises (5 minutes): Diaphragmatic breathing and posture correction to enhance neuromuscular coordination. Total session: 30 minutes, twice weekly for 6 weeks.  
Comparator Agent  Standard Care  Conventional conservative TMD care: education, warm compress, and jaw exercises. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults diagnosed with Temporomandibular Disorders (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) will be eligible for the study. Participants must have experienced chronic orofacial pain for more than three months and demonstrate willingness to provide informed consent and comply with all study procedures.
 
 
ExclusionCriteria 
Details  Individuals with a history of orofacial surgery or trauma within the past six months, neurological disorders affecting facial muscles, or those currently undergoing orthodontic treatment or using occlusal splint therapy will be excluded. Participants with severe psychiatric illness or those unable to complete study questionnaires, as well as pregnant or lactating women, will also not be eligible for inclusion in the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes of this study include changes in pain intensity measured using the Visual Analogue Scale (VAS), changes in oral function assessed through the Jaw Functional Limitation Scale (JFLS), and evaluation of orofacial alignment using clinical assessment and standardized photographs. Additionally, patient-reported satisfaction with facial glow will be measured using a Likert scale.  Baseline, Week 3, Week 6 (end of treatment), 1-month follow-up. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include assessment of quality of life using the Oral Health Impact Profile (OHIP-14), evaluation of anxiety and depression levels with the Hospital Anxiety and Depression Scale (HADS), and monitoring of the intervention’s safety profile through systematic reporting of any adverse events.  Baseline, Week 3, Week 6 (end of treatment), 1-month follow-up. 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Temporomandibular Disorders (TMD) affect jaw function, cause chronic pain, and may negatively impact facial aesthetics and quality of life. Conventional treatments often focus on pain reduction but rarely address aesthetic concerns or cranio cervical dysfunctions. This randomized controlled trial will evaluate the effectiveness of Functional Aesthetic Therapy, an integrated rehabilitation program combining cranio cervical soft tissue manipulation, orofacial myofunctional therapy, facial lymphatic drainage, and postural breathing exercises. Adult participants aged 18 to 60 years with TMD diagnosed according to DC TMD criteria and chronic orofacial pain lasting more than three months will be enrolled and randomized into two groups. The intervention group will undergo 30-minute Functional Aesthetic Therapy sessions twice weekly for six weeks, while the control group will receive standard conservative care consisting of education, warm compress, and jaw exercises. Primary outcomes include changes in pain intensity measured by the Visual Analogue Scale, oral function assessed with the Jaw Functional Limitation Scale, orofacial alignment evaluated through clinical and photographic assessments, and patient satisfaction with facial glow. Secondary outcomes include quality of life assessed by OHIP-14, anxiety and depression measured by HADS, and monitoring of adverse events for safety evaluation. This study will provide patient-reported outcome-based evidence for a novel multidisciplinary TMD rehabilitation strategy. 
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