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

NCT06775392 | Completed Phase 1

• 1 other identifier: KCDSHEC/IP/2023/V1/P4a
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Plaque Index

  21DAYS

• Gingival index

  21DAYS

• Modified Sulcus Bleeding Index

  21days

Study Arms (3)

Group-1-SRP alone

ACTIVE COMPARATOR

control group is treated with SRP alone

Procedure: SRP

Group-2-2%bromelain-quercetin gel

EXPERIMENTAL

test group treated with 2%bromelain-quercetin gel

Drug: bromelain-quercetin gel

Group-3-0.2% chlorhexidine gel

ACTIVE COMPARATOR

test group treated with chlorhexidine gel

Drug: chlorhexidine gel

Interventions

bromelain-quercetin gel DRUG

bromelain-quercetin gel is prepared from capsules in laboratory

Group-2-2%bromelain-quercetin gel

chlorhexidine gel DRUG

chlorhexidine gel is prepared in laboratory

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

Location

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

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: January 9, 2025
• First Posted: January 15, 2025
• Study Start: January 4, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

IN (1)