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

NCT06505759 | Recruiting Phase 1

• 1 other identifier: 02-D012-147453
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Plaque Index

  3 months

• Gingival index

  3 month

• Modified Sulcus Bleeding Index

  3 months

Study Arms (3)

GROUP 1-SRP alone

ACTIVE COMPARATOR

control group is treated with SRP alone

Procedure: SRP

GROUP 2-0.2% BROMELAIN gel

EXPERIMENTAL

test group is treated with bromelain gel

Drug: Bromelain gel

GROUP 3-0.2% CHLORHEXIDINE gel

ACTIVE COMPARATOR

test group is treated with chlorhexidine gel

Drug: chlorhexidine gel

Interventions

Bromelain gel DRUG

bromelain gel is prepared from bromelain capsules in laboratory

GROUP 2-0.2% BROMELAIN gel

chlorhexidine gel DRUG

chlorhexidine gel is prepared from mouth wash

GROUP 3-0.2% CHLORHEXIDINE gel

SRP PROCEDURE

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

GROUP 1-SRP alone

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI

Bengaluru, Karnataka, 562157, India

RECRUITING

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

DR .Prabhuji MLV, MDS

CONTACT

9448057407; prabhujimlv@gmail.com

DR.NALLAGATLA VAMSI VENKATAKRISHNA SAI, MDS

CONTACT

8499086673; vamsi.prince.sai17@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

IN (1)