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

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

Study Overview

• Status: Completed
• Conditions: Periodontal Pocket
• Intervention / Treatment: Procedure: SRP; Drug: bromelain-quercetin gel; Drug: chlorhexidine gel

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 562157
      • Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group-1-SRP alone; control group is treated with SRP alone	Procedure: SRP; Scaling and root planing was done with ultra sonic and hand scaling
Experimental: Group-2-2%bromelain-quercetin gel; test group treated with 2%bromelain-quercetin gel	Drug: bromelain-quercetin gel; bromelain-quercetin gel is prepared from capsules in laboratory
Active Comparator: Group-3-0.2% chlorhexidine gel; test group treated with chlorhexidine gel	Drug: chlorhexidine gel; chlorhexidine gel is prepared in laboratory

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	measured on the tooth surface using a probe	21DAYS
Gingival index	measured on the tooth surface using a probe	21DAYS
Modified Sulcus Bleeding Index	measured on the tooth surface using a probe	21days

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Pocket; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents; Anti-Infective Agents, Local; Disinfectants; Quercetin; Chlorhexidine
• Other Study ID Numbers: KCDSHEC/IP/2023/V1/P4a

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No