FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100177 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 01/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of herbal toothpastes with a conventional toothpaste for maintaining oral hygiene in patients undergoing orthodontic treatment. 
Scientific Title of Study   Comparative evaluation of the antiplaque efficacy of two herbal toothpastes and a triclosan toothpaste on patients undergoing orthodontic treatment. 
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 Astha Rajbhandari  
Designation  Post graduate (Department of Orthodontics and dentofacial orthopedics) 
Affiliation  A B Shetty Memorial Institute of Dental Sciences 
Address  Department of Orthodontics and dentofacial orthopedics A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7318293795  
Fax    
Email  asthar.394@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MS Ravi 
Designation  Professor, Head of Department, Vice Principal 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Department of Orthodontics and dentofacial orthopedics A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845221386  
Fax    
Email  drmsravi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MS Ravi 
Designation  Professor, Head of Department, Vice Principal 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Department of Orthodontics and dentofacial orthopedics A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845221386  
Fax    
Email  drmsravi@gmail.com  
 
Source of Monetary or Material Support  
A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore Pincode: 575018 India 
 
Primary Sponsor  
Name  Dr Astha Rajbhandari  
Address  Department of Orthodontics and Dentofacial Orthopedics A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore Pincode: 575018 India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Professor Dr MS Ravi  A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ASTHA RAJBHANDARI  A B Shetty Memorial Institute Of Dental Sciences  Department of Orthodontics and Dentofacial Orthopedics
Dakshina Kannada
KARNATAKA 
7318293795

asthar.394@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMITTEE ABSMIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K050||Acute gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Herbal toothpaste 1 (Dantasurabhi)  Total duration of intervention: 3 days. Participants undergoing orthodontic treatment will use a herbal dentifrice (Dantasurabhi) twice daily for 3 days. Plaque Index and Gingival Index will be recorded at baseline and after 72 hours of use.  
Intervention  Herbal toothpaste 2 (Dabur red)  Total duration of intervention: 3 days. Participants will be instructed to use a commercially available herbal toothpaste (Dabur red) twice daily for 3 days. Clinical parameters will be recorded at baseline and after 72 hours. 
Comparator Agent  Triclosan-containing toothpaste  Total duration: 3 days. The antiplaque and gingival efficacy of herbal dentifrices will be compared against a triclosan-containing toothpaste using standardized plaque and gingival indices after 72 hours of use. 
Intervention  Triclosan-containing toothpaste (Colgate Total)  Total duration of intervention: 3 days. Participants will use a triclosan-containing toothpaste twice daily for 3 days. Plaque and gingival indices will be assessed at baseline and after 72 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Diagnosed with mild- moderate gingivitis.
Undergoing orthodontic treatment.
Patients who are willing to provide consent. 
 
ExclusionCriteria 
Details  History of periodontitis
History of any systemic diseases that affect the periodontium
Pregnant or lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluation of reduction in dental plaque accumulation following short-term use of different dentifrices in patients undergoing orthodontic treatment.  Baseline, Day 3 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of improvement in gingival health following short-term use of different dentifrices in patients undergoing orthodontic treatment.  Baseline, Day 3 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   15/01/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Need for study
Dental plaque is a structured biofilm that plays a central role in the development of gingival inflammation and periodontal disease. Changes in plaque microenvironment can lead to microbial dysbiosis and initiate an inflammatory cascade, which may progress to periodontitis if left untreated. Effective plaque control is therefore essential, especially in patients undergoing orthodontic treatment who are at an increased risk of plaque accumulation. Dentifices containing chemical agents such as triclosan are widely used for plaque control but may be associated with undesirable side effects. This has led to increased interest in herbal dentrifices, which are perceived as safer alternatives. However, evidence regarding their antiplaque efficacy remains inconsistent, highlighting the need for comparative evaluation.

Aim: To compare the efficacy of Herbal toothpastes with a triclosan-containing toothpaste on periodontal parameters of patients undergoing orthodontic treatment. 

Objectives: 
1. To evaluate the antiplaque efficacy of a new herbal toothpaste. 

2. To evaluate the antiplaque efficacy of one more commonly used herbal toothpaste.

3.  To evaluate the antiplaque efficacy of triclosan-containing toothpaste.

4. To compare the antiplaque efficacy of two herbal toothpastes with that of the commonly used triclosan-containing toothpaste.

Methodology: 

Participants will be given detailed information about the study, and written consent will be obtained. They will be blinded and after the assignment of groups, randomisation will be done by drawing lots.
All participants will undergo an oral examination on Day 0 (Baseline).
Then they will receive a dentrifice with labels removed and coded with an alphabet. 
At initial visit, plaque and gingival index will be recorded after brushing in morning hours (Baseline). 
Fones toothbrushing technique will be demonstrated for the standardisation of brushing technique. Then they will be instructed to use a new herbal toothpaste(Toothapaste 1) for 3 days twice a day. After 72 hours, evaluation of plaque and gingival scores will be repeated.
To mitigate the risk of carryover effect, a washout period will be scheduled for a period of 2 weeks.
Participants will be asked to use a regular dentrifice for following 2 weeks. They will be instructed not to use any herbal or medicated dentifrices as this could influence the result of the study. 
Then they will be recalled after 2 weeks and evaluated for plaque and gingival scores(Baseline for toothpaste 2). Triclosan-containing toothpaste will then be given for next 3 days to be used twice a day. After 72 hours of use of toothpaste 2, plaque and gingival indices will be assessed once again in morning hours after brushing.
Participants will be asked to use a regular dentrifice for following 2 weeks. 
After 2 weeks, they will again be recalled and evaluated for plaque and gingival scores (Baseline for toothpaste 3). Another herbal toothpaste will then be given for the next 3 days to be used twice a day.
After 72 hours of use of toothpaste 3, plaque and gingival indices will be assessed once again in the morning hours after brushing. This will be followed by phase 1 therapy for study subjects, and they will be placed on maintenance therapy.
Data will be collected in Excel and analysed with statistical analysis.

Purpose of the study (Clinical Significance)

The study evaluates the effectiveness of herbal and triclosan-containing dentrifices in controlling plaque and gingival inflammation in patients undergoing orthodontic treatment. 
Improved periodontal health may help reduce inflammation-related complications and support a favourable biological environment during orthodontic therapy.
The finding may aid clinicians in selecting suitable dentrifices, including herbal alternatives for orthodontic patients.


 
Close