| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K050||Acute gingivitis. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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 | | 2 | Intervention Arm | Drug | Classical | | (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. |