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

NCT ID: NCT06505759

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-31

Brief Summary

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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

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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

Conditions

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Periodontal Pocket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GROUP 1-SRP alone

control group is treated with SRP alone

Group Type ACTIVE_COMPARATOR

SRP

Intervention Type PROCEDURE

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

GROUP 2-0.2% BROMELAIN gel

test group is treated with bromelain gel

Group Type EXPERIMENTAL

Bromelain gel

Intervention Type DRUG

bromelain gel is prepared from bromelain capsules in laboratory

GROUP 3-0.2% CHLORHEXIDINE gel

test group is treated with chlorhexidine gel

Group Type ACTIVE_COMPARATOR

chlorhexidine gel

Intervention Type DRUG

chlorhexidine gel is prepared from mouth wash

Interventions

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Bromelain gel

bromelain gel is prepared from bromelain capsules in laboratory

Intervention Type DRUG

chlorhexidine gel

chlorhexidine gel is prepared from mouth wash

Intervention Type DRUG

SRP

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI

Bengaluru, Karnataka, India

Site Status RECRUITING

Countries

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India

Central Contacts

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DR .Prabhuji MLV, MDS

Role: CONTACT

9448057407

DR.NALLAGATLA VAMSI VENKATAKRISHNA SAI, MDS

Role: CONTACT

8499086673 ext. 91

Facility Contacts

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Dr. MLV Prabhuji

Role: primary

Other Identifiers

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02-D012-147453

Identifier Type: -

Identifier Source: org_study_id

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