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

Phase 1

Recruiting

• Conditions: Periodontal Pocket
• Interventions: Drug: chlorhexidine gel; Drug: Bromelain gel; Procedure: SRP

• Registration Number: NCT06505759
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary

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

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 Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 is treated with chlorhexidine gel
GROUP 2-0.2% BROMELAIN gel	Bromelain gel	test group is treated with bromelain gel
GROUP 1-SRP alone	SRP	control group is treated with SRP alone

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gingival index	3 month	measured on the tooth surface using a probe
Modified Sulcus Bleeding Index	3 months	measured on the tooth surface using a probe
Plaque Index	3 months	measured on the tooth surface using a probe

Trial Locations

Locations (1)

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