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CTRI Number  CTRI/2025/02/080300 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Chamomile, Mixed herbal and Conventional Gum Paint among adult patients with Gingivitis  
Scientific Title of Study   Efficacy of Chamomile, Mixed herbal and Conventional Gum Paint among adult patients with Gingivitis - A Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNandhini Ramesh 
Designation  Post Graduate 
Affiliation  Karpaga Vinayaga Institute of Dental Science 
Address  Room no: 2 3rd floor department of Public Health Dentistry GST road Chinna Kolambakkam Madhuranthagam Karpaga Vinayaga Institute of Dental Science Kancheepuram

Kancheepuram
TAMIL NADU
603308
India 
Phone  9600841237  
Fax    
Email  nandyannam.1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishnu prasad 
Designation  Head of the Department 
Affiliation  Karpaga Vinayaga Institute of Dental Science 
Address  Room no: 2 3rd floor department of Public Health Dentistry GST road Chinna Kolambakkam Madhuranthagam Karpaga Vinayaga Institute of Dental Science Kancheepuram

Kancheepuram
TAMIL NADU
603308
India 
Phone  9894720548  
Fax    
Email  vishnumds@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrNandhini Ramesh 
Designation  Post Graduate 
Affiliation  Karpaga Vinayaga Institute of Dental Science 
Address  Room no: 2 3rd floor department of Public Health Dentistry GST road Chinna Kolambakkam Madhuranthagam Karpaga Vinayaga Institute of Dental Science Kancheepuram

Kancheepuram
TAMIL NADU
603308
India 
Phone  9600841237  
Fax    
Email  nandyannam.1996@gmail.com  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental Sciences, GST Road, Chinnakolambakkam, Madhuranthagam, Chengalpet District, Tamilnadu - 603308 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 R Nandhini  Karpaga Vinayaga Institute of Dental Science  Room no: 2, 3rd floor, Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental Science, Madhuranthagam, Chengalpet district Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 		 9600841237

nandyannam.1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee-Karpaga Vinayaga Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gum paint (Astringent) can be applied for those who were having mild gingivitis score measuring by Russel’s periodontal index  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chamomile Gum paint  Compared with Sensoform gum paint (Conventional) and Sensopride Gum paint (Mixed herbal) The duration of gum paint for 2 weeks 
Comparator Agent  Sensoform gum paint (Conventional)and sensopride gum paint (Mixed herbal).  Compared with the intervention group Chamomile Gum paint The duration of gum paint is 2 weeks of application 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Above 18 years population
Free from systemic diseases
Those who were having 1 and 2 scoring when measured by Russel’s periodontal index (Russell A.L in 1956)
 
 
ExclusionCriteria 
Details  Subjects who are under medication in the last 3 month.
3 and 4 score of Russel’s periodontal index are excluded.
Those who have done recent periodontal therapy.
Undergoing Orthodontic treatment.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To analysis Gingivitis by,
Landry Gingival healing index
Rustogi Modified Navy Plaque Index
C reactive protein 		 At baseline and 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  nil 
 
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)   20/02/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   The population age group of 18-40 will be recruited under the inclusion criteria. Baseline value of Gingival healing, Plaque score and c reactive protein will be checked and standardization of scaling will be done among all participants. Computer randomization done and allocation concealment of 1:1:1:1 will be done. Group A will receive Sensoform, Group B will receive Sensopride, Group C will receive Chamomile and Group D will receive only scaling without gum paint. Finally check for Gingival healing, Plaque score and c reactive protein. 
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