| 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
|
|
|
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
|
|
|
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. |