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Clinical Trials/CTRI/2025/01/079418
CTRI/2025/01/079418RecruitingPhase 3

Evaluation of Efficacy of Chamomilla With Babul Gum Paint In Comparison With Chlorhexidine Gluconate Gum Paint On Periodontal Health Status A Clinico Microbiological Study

Dr Ankita Gadekar1 site in 1 country60 target enrollmentStarted: February 3, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To evaluate the efficacy of chamomilla with babul gum paint on periodontal health status

Study Overview

Brief Summary

EVALUATION OF EFFICACY OF CHAMOMILLA WITH BABUL GUMPAINT IN COMPARISON WITH CHLORHEXIDINE GLUCONATE GUMPAINT ON PERIODONTAL HEALTH STATUS: A CLINICO‑MICROBIOLOGICAL STUDY

 Abstract: Gingivitis and Periodontitis are a multifactorial inflammatory disease of the oral cavity that results in alveolar bone destruction and is main reason for tooth loss. Gum paint provide a safe and effective chemical means of reducing or eliminating bacteria and relieving infection of oral tissue. Herbs and plant-derived products have a long history of safe use as natural products in the treatment of various diseases. The primary objective of study is to evaluate and compare the efficacy of chamomilla with babul gum paint and chlorhexidine gluconate gum paint on periodontal health status. It is randomised clinical trial study with 60 adult patient having mild to moderate gingivitis and periodontitis. They were divided into 2 groups each with 30 patients. Group A were given Herbal gumpaint and Group B given conventional gumpaint. All participants were brought to baseline. Indices were taken at baseline, 7 days, 14 days and 21 days. MIC (Minimal Inhibitory Concentration) and zone of inhibition was checked both Streptococcus mutans, Lactobacillus, Prophyromonas Gingivalis,, Tannerella  forsythia, Prevotella Intermedia . Gingival crevicular fluid (GCF) were taken at baseline and after 21 days to check Colony forming unit (CFU) of the samples. Data will be analyzed using SPSS software v23. The level of significance will be kept at 5%. Data will be tested for normality using the Shapiro-Wilk test. Intragroup comparison of the variables will be done using either repeated measures ANOVA test or Friedman two-way ANOVA test followed by Bonferroni test for pairwise comparisons. Intergroup comparison of the variables at each interval will be done using either the independent t test or the mann whitney test.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with mild to moderate gingivitis and periodontitis.

Exclusion Criteria

  • Patient with major systemic disease Patient not willing to participate in study.

Outcomes

Primary Outcomes

To evaluate the efficacy of chamomilla with babul gum paint on periodontal health status

Time Frame: Baseline 7 days 14 days and 21 days

Secondary Outcomes

  • To evaluate and compare the Zone of inhibition of Herbal and Chlorhexidine Gum paint on Streptococcus Mutans Lactobacillus Prophyromonas Gingivalis Tannerella forsythia Prevotella Intermedia(Before and after use of gum paint)

Investigators

Sponsor
Dr Ankita Gadekar
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ankita Vinayak Gadekar

JMFs A.C.P.M Dental College

Study Sites (1)

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