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CTRI Number  CTRI/2025/01/079418 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Dentistry 
Study Design  Other 
Public Title of Study   Comparison of Chamomilla With Babul Gum paint And Chlorhexidine Gluconate Gum paint On Periodontal Health Status 
Scientific Title of Study   Evaluation of Efficacy of Chamomilla With Babul Gum Paint In Comparison With Chlorhexidine Gluconate Gum Paint On Periodontal Health Status A Clinico Microbiological Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita Vinayak Gadekar 
Designation  PG Student 
Affiliation  JMFs A.C.P.M Dental College 
Address  Department of Public Health Dentistry 3rd Floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9403483403  
Fax    
Email  gadekarankita2014@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth Vishwakarma 
Designation  Professor 
Affiliation  JMFs A.C.P.M Dental College 
Address  Department of Public Health Dentistry 3rd Floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9766745627  
Fax    
Email  dr_prashanthvk@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankita Vinayak Gadekar 
Designation  PG Student 
Affiliation  JMFs A.C.P.M Dental College 
Address  Department of Public Health Dentistry 3rd Floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9403483404  
Fax    
Email  gadekarankita2014@gmail.com  
 
Source of Monetary or Material Support  
JMFs ACPM Dental College Dhule 424001 Maharashtra India  
 
Primary Sponsor  
Name  Dr Ankita Gadekar 
Address  JMFs ACPM Dental College Dhule 424001 Maharashtra India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ankita Gadekar  JMFs ACPM DENTAL COLLEGE  Department of Public Health Room No 8 Third Floor Dentistry JMFs ACPM Dental College Dhule
Dhule
MAHARASHTRA 
9403483403

gadekarankita2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ANNASAHEB CHUDAMAN PATIL MEMORIAL DENTAL COLLEGE, INSTITUTION ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K050||Acute gingivitis. Ayurveda Condition: DANTAMULAGATAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Matricaria chamomilla and Acacia arabica , Reference: Sah, A.; Naseef, P.P.; Kuruniyan, M.S.; Jain, G.K.; Zakir, F.; Aggarwal, G. A Comprehensive Study of Therapeutic Applications of Chamomile. Pharmaceuticals 2022, 15, 1284., Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 3(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Massage gums two times a day
2Intervention ArmDrugClassical(1) Medicine Name: Chlorhexidine gumpaint, Reference: Sukhabogi JR, Shekar BRC, Ramana IV, Yadav SS, Kumar GS, Harita N. Antiplaque Efficacy of Tooth and Gums Tonic, Hiora-GA Gel, and Spirogyl Gum Paint in Comparison with Chlorhexidine M Gel: A Double-blind Randomized Control Trial. Contemp Clin Dent. 2017 Jan-Mar;8(1):42-47. , Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 3(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Massage gums two times a day
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with mild to moderate gingivitis and periodontitis 
 
ExclusionCriteria 
Details  Patient with major systemic disease
Patient not willing to participate in study 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of chamomilla with babul gum paint on periodontal health status  Baseline 7 days 14 days and 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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