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Recruiting 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

Phase I Interventional Periodontal Pocket

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bromelain gel, chlorhexidine gel, SRP.
Who it may be relevant to
Registry conditions: Periodontal Pocket. Basic parameters: 30 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

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

Interventions

  • Drug Bromelain gel
    bromelain gel is prepared from bromelain capsules in laboratory
  • Drug chlorhexidine gel
    chlorhexidine gel is prepared from mouth wash
  • Procedure SRP
    Scaling and root planing was done with ultra sonic and hand scaling

Primary outcome measures

  • Probing pocket Depth (PPD) [Time frame: 3 months]
  • Relative attachment level (RAL) [Time frame: 3 months]
Secondary outcome measures (3)
  • Plaque Index [Time frame: 3 months]
  • Gingival index [Time frame: 3 month]
  • Modified Sulcus Bleeding Index [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI — Bengaluru

Identifiers

NCT: NCT06505759 · 02-D012-147453

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗