| CTRI Number |
CTRI/2025/02/081311 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A COMPARATIVE EVALUATION OF OXYGEN RELEASING ORAL GEL AND HYALURONIC ACID GEL IN THE TREATMENT OF CLASS II FURCATION DEFECTS A CLINICO – RADIOGRAPHIC STUDY |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF OXYGEN RELEASING ORAL GEL AND 0.8 PERCENTAGE HYALURONIC ACID GEL IN THE TREATMENT OF CLASS II FURCATION DEFECTS A CLINICO – RADIOGRAPHIC STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PAVITRA J |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
RUHS COLLEGE OF DENTAL SCIENCES |
| Address |
ROOM NO.6,
DEPARTMENT OF PERIODONTICS,
RUHS COLLEGE OF DENTAL
SCIENCES,
OPPOSITE TO SPACE CINEMA,
SHASTRI NAGAR,
JAIPUR
Jaipur RAJASTHAN 302016 India |
| Phone |
8778291524 |
| Fax |
|
| Email |
pavitrajayakumar24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SHARMISTHA VIJAY |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
RUHS COLLEGE OF DENTAL SCIENCESS |
| Address |
ROOM NO.6,
DEPARTMENT OF PERIODONTICS,
RUHS COLLEGE OF DENTAL SCIENCES,
OPPOSITE TO SPACE CINEMA,
SHASTRI NAGAR,
JAIPUR
Jaipur RAJASTHAN 302016 India |
| Phone |
|
| Fax |
|
| Email |
sharmisthavijay@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. PAVITRA J |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
RUHS COLLEGE OF DENTAL SCIENCESS |
| Address |
ROOM NO.6,
DEPARTMENT OF PERIODONTICS
RUHS COLLEGE OF DENTAL SCIENCES,
OPPOSITE TO SPACE CINEMA,
SHASTRI NAGAR,
JAIPUR
Jaipur RAJASTHAN 302016 India |
| Phone |
8778291524 |
| Fax |
|
| Email |
pavitrajayakumar24@gmail.com |
|
|
Source of Monetary or Material Support
|
| RUHS COLLEGE OF DENTAL SCIENCES,
SHASTRI NAGAR,OPPOSITE TO SPACE CINEMA,JAIPUR,INDIA PINCODE-302016 |
|
|
Primary Sponsor
|
| Name |
Dr PAVITRA JAYAKUMAR |
| Address |
ROOM NO.6, DEPARTMENT OF PERIODONTICS, RUHS COLLEGE OF DENTAL SCIENCES,
SHASTRI NAGAR,
JAIPUR |
| 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 |
| DRPAVITRA J |
RUHS COLLEGE OF DENTAL SCIENCES |
ROOM MO.6,
DEPARTMENT OF PERIODONTICS, RUHS COLLEGE OF DENTAL SCIENCES,
OPPOSITE TO SPACE CINEMA Jaipur RAJASTHAN |
8778291524
pavitrajayakumar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS COLLEGE OF DENTAL SCIENCES ETHICAL COMMITEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.8% hyaluronic acid gel |
0.8% hyaluronic acid gel along with hydroxyappaitte bone graft will be paced in grade 2 furcation defect after open flap debridement once topically . |
| Intervention |
oxygen releasing oral gel |
oxygen releasing oral along with hydroxyappatite bone graft will be placed in grade 2 furcation defect after open flap debridement once topically |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Chronic Periodontitis with Grade II
furcation defects with horizontal defect of atleast 3 mm in
mandibular molars.
2. Individuals with good general health and with no
systemic diseases like diabetes, bleeding disorders,
hypertension, allergic reaction, cardio-vascular diseases
were recruited to participate in this study.
3. Patients of both sexes between the age group of 30 – 50
years .
4. Teeth with functional antagonist were included. |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (PI)
2. Gingival Index (GI)
3. Probing pocket depth (PPD).
4. Relative vertical clinical attachment level (RV-CAL)
5. Relative horizontal clinical attachment level (RH-CAL)
|
BASELINE AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (PI)
2. Gingival Index (GI) |
BASELINE ,3 & 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
28/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
| · Periodontitis is a complex multifactorial disease, characterized by clinical attachment loss (CAL) and formation of osseous deformities, including furcation and intra bony defects. · The furcation can be defined as the anatomic area of a multirooted tooth in which the roots diverge. Furcation invasion or involvement is the result of pathologic resorption of the supporting alveolar bone within a furcation, typically derived from the progression of chronic or aggressive periodontitis. · Molar furcation involvement is one of the most common dento-alveolar sequelae of periodontal disease. The application of a specific treatment method for furcation involvement requires a thorough understanding of tooth anatomy, etiologic factors, and the biologic basis for treatment modalities. · Oxygen releasing oral gel has the particularity to release oxygen at a therapeutic concentration in the affected tissues. The therapeutic effects of blue m gel are neovascularization, removal of toxins, stimulation and formation of new blood cells, increasing the production of stem cells, which leads to more rapid healing, antibacterial effect, antihistamine effect, antimycotic effect. · Hyaluronic acid (HA) maintains cell viability, and increases proliferation and early osteogenic differentiation. · HA accelerates cell differentiation and migration during tissue formation and repair process has been utilized in non-surgical periodontal therapy, peri-implantitis management, root coverage procedures, management of furcation involvement, and socket preservation. | Thus, this the kind of first study to assess the efficacy of oxygen releasing oral gel and hyaluronic acid gel in the treatment of Class II Furcation Defect. |