| CTRI Number |
CTRI/2025/09/094405 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| 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 to see if a special physiotherapy and osteopathy program can prevent jaw and facial pain in people after dental treatment |
|
Scientific Title of Study
|
Effectiveness of a PhysiOsteopathic Program to Prevent Temporomandibular and Cervicofacial Pain After Dental Procedures: A 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 |
Uni-Hospital, Block no-3, Room no 105.Department of Physiotherapy.
Jalandhar
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Uni-Hospital, Block no-3, Room no 105.Department of Physiotherapy.
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
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, Block no-3, Room no 105.Department of Physiotherapy.
Kapurthala
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Block-38, Division of Research and Development, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Punjab (INDIA) PIN-144411 |
|
|
Primary Sponsor
|
| Name |
Dr Ramesh Chandra Patra |
| Address |
Block 4, Room no 105, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Punjab (INDIA) PIN-144411 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
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-Uospital,Department of Physiotherapy,Block 3, Room no 105 Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara,
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M279||Disease of jaws, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PhysiOsteopathic Program |
The treatment duration for all intervention arms will follow a structured 4-week protocol. Participants in the cranio cervical physiotherapy and osteopathy group (CCPT) will begin treatment 48 to 72 hours after their dental procedure. This intervention will include three to five in-person sessions delivered over two to three weeks. The treatment will consist of manual therapy techniques such as temporomandibular joint mobilization, masticatory muscle release, and cervical joint mobilization. Neuromuscular training will focus on jaw control, deep cervical flexor activation, and scapular stabilization. Participants will also be instructed in a daily home exercise program lasting five to ten minutes, along with posture correction and ergonomics education for self-management. The combined therapy group (CMT) will receive the same physiotherapy and osteopathy program as the CCPT group in addition to occlusal splint therapy according to standard dental care. The control group (CST) will receive standard occlusal splint therapy only, with no additional physiotherapy or exercise intervention. |
| Comparator Agent |
Standard occlusal splint therapy only |
Participants in this group will receive conventional occlusal splint therapy as per standard dental practice. A custom-made occlusal stabilization splint will be fabricated and fitted by a qualified dentist. The splint will be designed to cover the maxillary or mandibular teeth, providing even occlusal contact and reducing abnormal loading of the temporomandibular joint. Participants will be instructed to wear the splint primarily during sleep or as advised by the dentist. No additional physiotherapy, osteopathy, or structured exercise interventions will be provided in this group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be adults aged 18 to 60 years who are scheduled to undergo dental procedures requiring at least 30 minutes of continuous mouth opening. Eligible participants must have no severe or active temporomandibular disorders (TMD) at baseline, as determined by the DC/TMD diagnostic criteria. They must be willing and able to attend physiotherapy sessions following their dental procedure. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they have a history of temporomandibular joint (TMJ) surgery or craniofacial trauma, systemic inflammatory disorders such as rheumatoid arthritis or fibromyalgia, or if they are currently undergoing physiotherapy for TMD or neck pain. Individuals with cognitive or physical impairments that would limit their ability to participate in the study will also be excluded. |
|
|
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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the incidence of clinically significant temporomandibular disorder (TMD) at 3 months following the dental procedure. Clinically significant TMD will be defined as meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for pain or dysfunction, accompanied by either a Numeric Rating Scale (NRS) pain score of 3 or higher (on a 0–10 scale) or a Jaw Functional Limitation Scale (JFLS) score of at least 10 points. |
At baseline,1 week, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will assess pain trajectory in the jaw, face, & neck, using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS). Maximum mouth opening (interincisal distance) & the Jaw Functional Limitation Scale (JFLS-20) will be used to evaluate jaw function, while the Neck Disability Index (NDI) will measure cervical function. Quality of life will be assessed with the Oral Health Impact Profile (OHIP-14) or EQ-5D. Additional parameters include muscle tenderness & trigger point scores, analgesic or rescue medication use, & documentation of any adverse events |
At baseline, 1 week, 4 weeks, & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized controlled trial aims to evaluate the effectiveness of a combined physiotherapy and osteopathy program in preventing temporomandibular joint and cervicofacial pain and dysfunction following dental procedures that require prolonged mouth opening. The study is based on the hypothesis that sustained stretching and loading of the temporomandibular joint and associated muscles during dental treatment can lead to nociceptive sensitization in the trigeminal system, resulting in pain and movement limitations in the jaw and cervical region. Participants aged 18 to 60 years undergoing dental procedures lasting 30 minutes or more will be randomly assigned to one of three groups: conventional splint therapy, cranio cervical physiotherapy and osteopathy, or an integrated combined therapy program. Outcomes will include pain scores, jaw and neck function, quality of life measures, and adverse events assessed over a three-month follow-up period. The primary goal is to determine whether the integrated combined therapy approach is more effective than standard care in preventing the onset of temporomandibular disorders and cervical dysfunction after dental procedures. |