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

Phase 1

Completed

• Conditions: Periodontal Pocket
• Interventions: Drug: chlorhexidine gel; Procedure: SRP; Drug: bromelain-quercetin gel

• Registration Number: NCT06775392
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

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.

Study Timeline

• Study Start: 2024-01-04
• Primary Completion: 2024-08-05
• Study Completion: 2024-08-05
• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-3-0.2% chlorhexidine gel	chlorhexidine gel	test group treated with chlorhexidine gel
Group-1-SRP alone	SRP	control group is treated with SRP alone
Group-2-2%bromelain-quercetin gel	bromelain-quercetin gel	test group treated with 2%bromelain-quercetin gel

Primary Outcome Measures

Name	Time	Method
PROBING POCKET DEPTH	21DAYS	measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
CLINICAL ATTACHMENT LEVEL	21DAYS	(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)

Secondary Outcome Measures

Name	Time	Method
Plaque Index	21DAYS	measured on the tooth surface using a probe
Gingival index	21DAYS	measured on the tooth surface using a probe
Modified Sulcus Bleeding Index	21days	measured on the tooth surface using a probe

Trial Locations

Locations (1)

Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI; 🇮🇳 Bengaluru, Karnataka, India