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CTRI Number  CTRI/2024/02/062579 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 23/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment modalities for TMJ disorders 
Scientific Title of Study   Evaluation of ozone therapy in comparison with occlusal splint in treating internal derangement of temporomandibular joint : a randomized controlled study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satyendra Pratap Singh  
Designation  Junior resident  
Affiliation  Faculty of dental sciences, Kgmu , Lucknow  
Address  Department of prosthodontics and crown and bridges, new dental building , faculty of dental sciences, kgmu Lucknow, Uttar Pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  7905666205  
Fax    
Email  drsatyendrapratapsingh29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bhaskar agarwal  
Designation  Professor JG 
Affiliation  Faculty of dental sciences, kgmu  
Address  Department of prosthodontics and crown and bridges, new dental building , 6th floor , faculty of dental sciences , kgmu , Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  8299616676  
Fax    
Email  bhaskaragarwal2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhaskar agarwal  
Designation  Professor JG 
Affiliation  Faculty of dental sciences, kgmu  
Address  Department of prosthodontics crown and bridges, new dental building, 6th floor, faculty of dental sciences , kgmu , Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  8299616676  
Fax    
Email  bhaskaragarwal2@gmail.com  
 
Source of Monetary or Material Support  
King George’s medical university, Lucknow , up  
 
Primary Sponsor  
Name  Satyendra Pratap Singh  
Address  Department of prosthodontics and crown and bridges, new dental building, 6th floor , faculty of dental sciences, kgmu, Lucknow  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Satyendra Pratap Singh   King George’s medical university   Department of prosthodontics and crown and bridges, new dental building , 6th floor , seminar room,Faculty of dental sciences, kgmu
Lucknow
UTTAR PRADESH 
7905666205

drsatyendrapratapsingh29@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King George’s Medical University U.P., Institutional Ethics Committee Lucknow - 226003 (UP) India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M266||Temporomandibular joint disorders, (2) ICD-10 Condition: M266||Temporomandibular joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Occlusal splint  Occlusal splints will be fabricated from auto polymerizing acrylic resin covering the maxillary teeth completely with 2 mm thickness of acrylic resin between maxillary and mandibular first molar teeth, as described by Okeson. Duration - 3 month  
Intervention  Ozone therapy  ozoneoxygen mixture will be injected into the upper part of the affected joint. The same procedures are repeated in the opposite joints for once  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Systemically healthy subjects with moderately severe and chronic pain and jaw dysfunction with compromised mouth opening  
 
ExclusionCriteria 
Details  a. Dental problem or sinus pathology potentially contributing to pain,
b. Immunocompromised patients.
c. Psychologically compromised patients.
d. Allergy to Local anesthesia
e. Active rheumatological condition.
f. Pain due to infection
g. G6PD Deficiency
h. Pregnancy or breast feeding.
i. Osseous defects
j. TMJ disarticulation.
k. Myofascial pain dysfunction as the sole or primary source of pain.
l. Edentulous subjects.
m. Limited opening secondary to extra-articular pathology.
n. Fibromyalagia.
o. Allergy to study medication 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of occlusal splint therapy and ozone therapy in terms of pain, mouth opening, lateral Mandibular excursion in temporomandibular joint disorders with internal disc derangement  1 week , 1 month , 3 month , 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effects of occlusal splint therapy and ozone therapy in terms of inflammation using thermoscan (FLIR make Thermal Imaging Camera – C5).  1 week , 1 month , 3 month , 6 month 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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   Phase 2 
Date of First Enrollment (India)   19/02/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The synovial articulation between the mandible and temporal bone is known as the temporomandibular joint (TMJ). Only mammals have this joint. The condylar head of the mandible, the temporal bone’s articulating surfaces, the articulating disc, and the articulating capsule make up this joint. The disc divides the TMJ cavity into upper and lower compartments and detaches the head of the condyle from the temporal bone. It offers a passively movable articular surface that allows the condylar head’s translatory movement. 

Disorders of the temporomandibular joint are quite prevalent, with a prevalence of about 52%. It is a broad word that really refers to a variety of clinical conditions that affect the TMJ and other structures connected to the masticatory system. They have a range of etiologies, including congenital, inflammatory, and traumatic. Moreover they exhibit poor wound healing and fibrosis brought on by ongoing, irreparable damage. 

TMJ problems impact the jaw joints and associated tissues, resulting in internal joint space derangement bone changes, and degenerative diseases. Disc displacements, with or without decrease, are among the internal TMJ disorders that frequently cause joint noises, pain, and discomfort in the TMJ region the current goals of treating temporomandibular joint diseases include reducing pain while doing daily activities and restoring a normal range of mandibular movements. Many therapeutic approaches are recommended for re-establishing the balance of the TMJ system, including conservative treatments including diet control, antidepressant medications/non- steroidal anti-inflammatory drugs (Nsaids), physiotherapy, and splints. Also taken into consideration are surgical procedures including arthrocentesis, arthroscopy, and open joint surgeries.

 The method of ozone and splint avoids the use of surgery as the first line of treatment and also overcomes the complications associated with direct intra articular injections of autologous blood and sclerosing agents. Ozone not only give symptomatic treatment, but it also helps in regeneration of the joint. Splints are frequently used in patients with TMD to reduce abnormal muscle activity, increase vertical height, and improve the stability of the TMJ. 

Now a days thermal imaging technology is being used for detection of temperature of joint. Increase or decrease in temperature has a direct relation with aggravation or reduction of inflammation.

 
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