| CTRI Number |
CTRI/2025/04/084068 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effect of occlusal splint therapy on jaw position and airway space in patients with jaw muscle pain |
|
Scientific Title of Study
|
Evaluating the Impact of Occlusal Splint Therapy on Upper Airway Dimensions and Mandibular Condylar Position in Myofascial Pain Patients with Average Skeletal Growth Patterns: A CBCT-based Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Karagir |
| Designation |
PhD Research Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Bharati Vidyapeeth (Deemed to be University) Dental
College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9975640086 |
| Fax |
|
| Email |
amol.karagir@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Mhapuskar |
| Designation |
Professor and Head |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Bharati Vidyapeeth (Deemed to be University) Dental
College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9850285143 |
| Fax |
|
| Email |
amit.mhapuskar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Mhapuskar |
| Designation |
Professor and Head |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Bharati Vidyapeeth (Deemed to be University) Dental
College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9850285143 |
| Fax |
|
| Email |
amit.mhapuskar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Wanlesswadi, Sangli Taluka Miraj, District Sangli, Maharashtra State, India 416416 |
|
|
Primary Sponsor
|
| Name |
Dr. Amol Karagir |
| Address |
Assistant Professor, Department of Oral Medicine and Radiology, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Sangli. |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amol Karagir |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sangli |
Bharati Vidyapeeth (Deemed to be University) Dental
College and Hospital Bharati Medical Campus Wanlesswadi Sangli 416416
Sangli
MAHARASHTRA |
9975640086
amol.karagir@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee of Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M609||Myositis, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Master Control group (No Intervention) |
Master Control Group volunteers with no history of TMJD or orofacial pain disorders, matched for age and gender with the TMJD group and who have been advised full volume CBCT for some other reasons, will be recruited.
It will be ensured that they meet the inclusion criteria. A Master Control Group plays a crucial role in research study, particularly in case-control design. It serves as a baseline for comparison to assess the effects of an intervention or condition.
In this study, the master healthy control group ( healthy individuals without TMJD) will be critical for establishing whether observed changes in airway dimensions and mandibular condylar position are due to myogenic TMJD or occlusal splint therapy.
|
| Intervention |
Occlusal Splint Therapy & Pharmacotherapy |
Description: The intervention group will receive customized occlusal splint therapy and Pharmacotherapy. • Participants will be prescribed NSAIDs + Muscle relaxant (Tab.Ibuprofen (400 mg) & Paracetamol (325mg) for pain relief and inflammation control AND in combination with chlorzoxazone (250mg) as muscle relaxant to reduce muscle spasms to reduce muscle spasms) for 5 days and SOS whenever symptoms re-occur An occlusal splint is a removable, intraoral appliance designed to alleviate temporomandibular joint (TMJ) stress and manage myogenic temporomandibular disorders (TMJD).
Type: Stabilization splint (also known as a flat-plane splint)
Material: Hard acrylic resin
Design: Covers the maxillary and mandibular arch, providing even occlusal contacts and reducing parafunctional activities.
Purpose:
To decrease muscle hyperactivity
To redistribute occlusal forces
To reduce TMJ loading
To improve mandibular condylar positioning and potentially increase upper airway dimensions
Duration and Protocol:
The splint will be worn nightly for a period of 3 months.
Adjustments will be made as necessary at regular follow-up visits.
Monitoring: Participants will be assessed using Cone Beam Computed Tomography (CBCT) to evaluate changes in upper airway dimensions and mandibular condylar position. Occlusal Splint Therapy has demonstrated effectiveness in reducing pain and improving jaw function in TMJD patients. It may also influence upper airway dimensions by repositioning the mandible. |
| Comparator Agent |
Pharmacotherapy Only |
Description: The comparator group will receive standard pharmacological management for myogenic temporomandibular disorders. Drug Name:
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and muscle relaxant : Ibuprofen (400 mg) & Paracetamol (325mg) for pain relief and inflammation control AND in combination with chlorzoxazone (250mg) as muscle relaxant to reduce muscle spasms to reduce muscle spasms. Duration and Protocol:
Pharmacotherapy will be administered for 3 months with regular follow-up assessments.
Monitoring: Efficacy will be monitored through patient-reported outcomes using a Visual Analog Scale (VAS) for pain, alongside CBCT analysis for objective airway and condylar changes. Pharmacotherapy is a widely accepted conservative treatment for myogenic TMJD, providing symptomatic relief. It serves as a suitable comparator to evaluate the additional benefits of occlusal splint therapy.
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age Range: 20-30 years. Diagnosis: Myogenic temporomandibular disorders (TMD), specifically myofascial pain. Skeletal Growth Pattern: Average skeletal growth pattern (determined by composite cephalometric analysis). Consent: Written informed consent provided. No Prior TMJ Treatment: No previous temporomandibular joint or occlusal therapy.
|
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| ExclusionCriteria |
| Details |
Systemic Diseases: Conditions affecting TMJ or airway (e.g., rheumatoid arthritis, sleep apnea). Craniofacial Anomalies: Cleft palate, craniosynostosis, etc. Previous Orthodontic/Surgical Treatment: Orthodontic or craniofacial surgery. Pregnancy: Excluded due to hormonal influences and CBCT radiation. Respiratory Conditions: Asthma, COPD, chronic rhinitis, etc. Psychiatric Disorders: Conditions affecting compliance (e.g., schizophrenia, major depression). TMJ Degenerative Diseases: Osteoarthritis, ankylosis, etc. Malocclusion/Skeletal Discrepancies: Class II, Class III, severe open bite. Medication Use: Medications affecting muscle or TMJ function (e.g., corticosteroids). Non-compliance: Inability to adhere to the study protocol.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in Upper Airway Dimensions measured via CBCT
Total Airway Volume: From nasopharynx to hypopharynx, measured in mm³, Segmental Airway Volumes: Nasopharyngeal Volume in mm³. Oropharyngeal Volume in mm³. Hypopharyngeal Volume in mm³ Minimum Cross-Sectional Area : Smallest area within the airway, measured in mm²
Airway Length: Distance from the nasopharynx to the hypopharynx, measured in mm
Presence of Obstructions or Anomalies: Identification of any airway obstructions (e.g., adenoids, hypertrophy).
2.Changes in Mandibular Condylar Position measured via CBCT
Joint Space Measurements, Condylar Ratio, Angular and Morphological Parameters: Sagittal Condylar Guidance Angle |
Baseline: Before initiation of the intervention
3 Months: Final assessment using CBCT |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison Between Groups:
Differences in upper airway dimensions and mandibular condylar position across all groups:
2. Correlation Analysis:
Relationship between changes in upper airway dimensions and alterations in mandibular condylar position.
3. Symptom Improvement:
Patient-reported improvement in TMJD symptoms (e.g., pain reduction, increased jaw mobility).
4. Clinical Observations:
Evaluation of the effectiveness of occlusal splint therapy in enhancing airway function and TMJ alignment.
|
Baseline: Before initiation of the intervention
6 Weeks: Interim assessment for pain and functional improvement
3 Months: Final assessment using CBCT and patient-reported outcomes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
01/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 control trial aims to evaluate the
impact of occlusal splint therapy on upper airway dimensions and mandibular
condylar position in patients with myogenic temporomandibular joint disorders
(TMJD) using Cone Beam Computed Tomography (CBCT). Participants will be divided
into three groups: Group 1 (intervention) will receive both occlusal splint
therapy and pharmacotherapy, Group 2 will receive pharmacotherapy alone, and
Group 3 will serve as healthy controls without TMJD. The intervention includes
a custom-fitted maxillary occlusal splint made of transparent acrylic resin
designed to promote mandibular repositioning and alleviate myogenic pain.
Pharmacotherapy consists of NSAIDs and muscle relaxants (BID for 5 days and as
needed). Pre-treatment CBCT scans will be conducted for all participants,
followed by post-treatment scans after 3 months for Groups 1 and 2. Primary
Outcome Measures will be the changes in Upper Airway Dimensions and Mandibular
Condylar Position assessed using CBCT, including airway volume, cross-sectional
area, airway length, joint space measurements, and condylar positioning. Secondary
Outcome Measures will be the comparative analysis of airway and condylar changes
across groups, Correlation between airway dimensions and condylar position., Symptom
improvement through pain reduction and enhanced jaw mobility, Evaluation of the
overall effectiveness of occlusal splint therapy. The results from this study
will provide valuable insights into the therapeutic benefits of occlusal splint
therapy for myogenic TMJD patients, potentially contributing to improved
treatment protocols. |