Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail

NCT ID: NCT06775392

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-04
• Study Completion Date: 2024-08-05

Brief Summary

Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail

Detailed Description

: Periodontitis is a biofilm associated disease that induces an irreversible inflammatory state that leads to the destruction of the supporting structure of the teeth. Management of periodontal disease is through thorough removal of biofilm which is pivotal for having better oral health. Scaling and root planning (SRP) is fundamental treatment for periodontitis. Years of documented research have established that chlorhexidine digluconate (CHX), gold standard of chemical plaque control agent is safe stable and effective in preventing and controlling plaque formation. Bromelain is an extract derived from Ananas comosus (popularly known as pineapple), contains proteinases that exhibits anti-inflammatory properties, antibacterial effect against periodontopathogens. Bromelain gel has shown to have chemicomechanical method of caries removal. Quercetin present in guava have excellent antibacterial actions against periodontal pathogens, Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Fusobacterium nucleatum (Fn). 2% Quercetin has shown to be advantageous for subgingival application after scaling and rootplaning. Bromelain-Quercetin gel has shown adjunctive effect for treatment in covid-19 patients. As there is less literature in this combination, we intend to study its effects. Individually bromelain and quercetin have been studied for treatment in oral cavity as gel form. This study will be first of its kind to check the efficacy of 2% bromelain-quercetin gel and to compare its effects with 0.2% Chlorhexidine in stage I/II and grade B periodontits.

Conditions

Periodontal Pocket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group-1-SRP alone

control group is treated with SRP alone

Group Type: ACTIVE_COMPARATOR

SRP

Intervention Type: PROCEDURE

Scaling and root planing was done with ultra sonic and hand scaling

Group-2-2%bromelain-quercetin gel

test group treated with 2%bromelain-quercetin gel

Group Type: EXPERIMENTAL

bromelain-quercetin gel

Intervention Type: DRUG

bromelain-quercetin gel is prepared from capsules in laboratory

Group-3-0.2% chlorhexidine gel

test group treated with chlorhexidine gel

Group Type: ACTIVE_COMPARATOR

chlorhexidine gel

Intervention Type: DRUG

chlorhexidine gel is prepared in laboratory

Interventions

bromelain-quercetin gel

bromelain-quercetin gel is prepared from capsules in laboratory

Intervention Type: DRUG

chlorhexidine gel

chlorhexidine gel is prepared in laboratory

Intervention Type: DRUG

SRP

Scaling and root planing was done with ultra sonic and hand scaling

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient with have chronic periodontitis in the age group between 30-50 years.
• Patients having ≥20 teeth.

-.Patients with radiographic evidence of bone loss in atleast two teeth.

• Patients who are systematically healthy.
• Patients with localized pockets with probing depth of ≤ 5mm.
• Patients who are cooperative and able to attend the hospital for regular follow-up.

Exclusion Criteria

• Patients who have received any surgical or nonsurgical therapy during past 6months
• Pregnant or lactating females.
• Use of systemic antibiotics in the past 6 months.
• Patient who are not willing to give a written informed consent

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI

Bengaluru, Karnataka, India

Countries

India

Other Identifiers

KCDSHEC/IP/2023/V1/P4a

Identifier Type: -

Identifier Source: org_study_id