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NCT Number: NCT06505759

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

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

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI

Bengaluru, Karnataka, 562157, India

Location status: Recruiting

Location contact

Dr. MLV Prabhuji

CONTACT

About this study

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

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bromelain gel

Drug

bromelain gel is prepared from bromelain capsules in laboratory

chlorhexidine gel

Drug

chlorhexidine gel is prepared from mouth wash

SRP

Procedure

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

Primary outcomes

  1. Probing pocket Depth (PPD)

    Time frame: 3 months

    measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA

  2. Relative attachment level (RAL)

    Time frame: 3 months

    (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)

Secondary outcomes

  1. Plaque Index

    Time frame: 3 months

    measured on the tooth surface using a probe

  2. Gingival index

    Time frame: 3 month

    measured on the tooth surface using a probe

  3. Modified Sulcus Bleeding Index

    Time frame: 3 months

    measured on the tooth surface using a probe

Study contacts

Contact information is provided by the study sponsor or research team.

DR .Prabhuji MLV, MDS

CONTACT

[email protected]

9448057407

DR.NALLAGATLA VAMSI VENKATAKRISHNA SAI, MDS

CONTACT

[email protected]

8499086673 ext. 91

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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