ClinicalTrials.gg
RecruitingNCT06505759Updated Jan 13, 2025

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

A Phase 1 interventional study of Bromelain gel and chlorhexidine gel in Periodontal Pocket, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Recruiting at 1 site in India. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Periodontal Pocket

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03

In context

Periodontal Pocket

130 studies on the registry are indexed under Periodontal Pocket; 35 are open to participants now.

This study's planned enrollment of 36 is above the median of 30 across 113 interventional studies indexed under Periodontal Pocket.

Browse Periodontal Pocket studies →

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    GROUP 1-SRP alone

    control group is treated with SRP alone

    Procedure: SRP

  • Experimental
    GROUP 2-0.2% BROMELAIN gel

    test group is treated with bromelain gel

    Drug: Bromelain gel

  • Active comparator
    GROUP 3-0.2% CHLORHEXIDINE gel

    test group is treated with chlorhexidine gel

    Drug: chlorhexidine gel

Interventions

  • bromelain gel is prepared from bromelain capsules in laboratory

  • chlorhexidine gel is prepared from mouth wash

  • ProcedureSRP

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

06

What researchers measure

Primary outcomes

  1. Probing pocket Depth (PPD)

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

    Time frame: 3 months

  2. Relative attachment level (RAL)

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

    Time frame: 3 months

Secondary outcomes

  1. Plaque Index

    measured on the tooth surface using a probe

    Time frame: 3 months

  2. Gingival index

    measured on the tooth surface using a probe

    Time frame: 3 month

  3. Modified Sulcus Bleeding Index

    measured on the tooth surface using a probe

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI
    Bengaluru, Karnataka 562157, India
    Recruiting
    • Dr. MLV Prabhuji · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06505759
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Sponsor
First posted
Jul 17, 2024
Start date
Jul 1, 2024
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Jan 13, 2025

Study contacts

DR .Prabhuji MLV, MDS
Contact
prabhujimlv@gmail.com
9448057407
DR.NALLAGATLA VAMSI VENKATAKRISHNA SAI, MDS
Contact
vamsi.prince.sai17@gmail.com
8499086673 ext. 91

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Bromelains

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