Evaluation of 2%Bromelain Gel With 0.2%CHX Gel as Subgingival LDD Following SRP in Stage II/III and Grade B Periodontitis -A RCT

Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis -Randomized Control Clinical Trail

The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis

Study Overview

• Status: Recruiting
• Conditions: Periodontal Pocket
• Intervention / Treatment: Procedure: SRP; Drug: Bromelain gel; Drug: chlorhexidine gel

Detailed Description

36 sites with periodontal pocket depth measuring 4-6mm were selected. The sites selected were divided into

1. Group I (Control)- 12 sites with Probing depth of ≥5mm treated with scaling and root planing alone.
2. Group II -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of bromelain gel.
3. Group III -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of chlorhexidine gel.

periodontal pack was placed and patient was recalled at 1week,4th week and 12th week

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: DR .Prabhuji MLV, MDS; Phone Number: 9448057407; Email: prabhujimlv@gmail.com
• Study Contact Backup: Name: DR.NALLAGATLA VAMSI VENKATAKRISHNA SAI, MDS; Phone Number: 91 8499086673; Email: vamsi.prince.sai17@gmail.com

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 562157
      • Recruiting
      • Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI
      • Contact: Dr. MLV Prabhuji

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 2-0.2% BROMELAIN gel; test group is treated with bromelain gel	Drug: Bromelain gel; bromelain gel is prepared from bromelain capsules in laboratory
Active Comparator: GROUP 3-0.2% CHLORHEXIDINE gel; test group is treated with chlorhexidine gel	Drug: chlorhexidine gel; chlorhexidine gel is prepared from mouth wash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket Depth (PPD)	measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA	3 months
Relative attachment level (RAL)	(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	measured on the tooth surface using a probe	3 months
Gingival index	measured on the tooth surface using a probe	3 month
Modified Sulcus Bleeding Index	measured on the tooth surface using a probe	3 months

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

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; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 02-D012-147453

Drug and device information, study documents

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