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Clinical Trials/CTRI/2025/02/081311
CTRI/2025/02/081311Not yet recruitingPhase 4

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

Dr PAVITRA JAYAKUMAR1 site in 1 country45 target enrollmentStarted: October 3, 2025Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
1. Plaque Index (PI)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects with Chronic Periodontitis with Grade II furcation defects with horizontal defect of atleast 3 mm in mandibular molars.
  • 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.
  • Patients of both sexes between the age group of 30 – 50 years .
  • Teeth with functional antagonist were included.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

1. Plaque Index (PI)

Time Frame: BASELINE AND 6 MONTHS

2. Gingival Index (GI)

Time Frame: BASELINE AND 6 MONTHS

3. Probing pocket depth (PPD).

Time Frame: BASELINE AND 6 MONTHS

4. Relative vertical clinical attachment level (RV-CAL)

Time Frame: BASELINE AND 6 MONTHS

5. Relative horizontal clinical attachment level (RH-CAL)

Time Frame: BASELINE AND 6 MONTHS

Secondary Outcomes

  • 1. Plaque Index (PI)(2. Gingival Index (GI))

Investigators

Sponsor
Dr PAVITRA JAYAKUMAR
Sponsor Class
Other [SELF ]

Study Sites (1)

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