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Clinical Trials/CTRI/2025/09/094605
CTRI/2025/09/094605
Not yet recruiting
Not Applicable

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

Dr Ramesh Chandra Patra1 site in 1 country66 target enrollmentStarted: September 23, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Ramesh Chandra Patra
Enrollment
66
Locations
1
Primary Endpoint
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.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Time Frame: Baseline, Week 3, Week 6 (end of treatment), 1-month follow-up.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Dr Ramesh Chandra Patra
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ramesh Chandra Patra

Lovely Professional University Faculty of Applied Medical Sciences

Study Sites (1)

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