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CTRI Number  CTRI/2026/02/104466 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 20/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   STOLIN R AND OMNIDENT TOOTHPASTE FOR GINGIVITIS 
Scientific Title of Study   COMPARATIVE EVALUATION OF ANTI-PLAQUE AND ANTI-GINGIVITIS EFFICACY OF STOLIN R AND OMNIDENT AS TOOTHPASTE IN CHRONIC GENERALISED GINGIVITIS PATIENTS - A RANDOMIZED CLINICAL TRAIL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PULLALAREVU DIVYA SAI 
Designation  POSTGRADUATE STUDENT 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Department of periodontics, Room no 12, Sri Rajiv Gandhi College of Dental sciences, RT Nagar Post Bengaluru , 560032

Bangalore Rural
KARNATAKA
560032
India 
Phone  06363364509  
Fax    
Email  divyasaipullalarevu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Umesh Yadalam 
Designation  Professor and Head of Department 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Department of periodontics, Room no 12, Sri Rajiv Gandhi College of Dental sciences, RT Nagar Post Bengaluru , 560032

Bangalore Rural
KARNATAKA
560032
India 
Phone  06363364509  
Fax    
Email  divyasaipullalarevu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PULLALAREVU DIVYA SAI 
Designation  POSTGRADUATE STUDENT 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Department of periodontics, Room no 12, Sri Rajiv Gandhi College of Dental sciences, RT Nagar Post Bengaluru , 560032

Bangalore Rural
KARNATAKA
560032
India 
Phone  06363364509  
Fax    
Email  divyasaipullalarevu@gmail.com  
 
Source of Monetary or Material Support  
Sri Rajiv Gandhi College of Dental sciences and Hospital, RT Nagar Post Bengaluru, Karnataka,India 560032  
 
Primary Sponsor  
Name  Dr PULLALAREVU DIVYA SAI 
Address  Sri Rajiv Gandhi College of Dental sciences and Hospital, RT Nagar Post Bengaluru, Karnataka,India 560032  
Type of Sponsor  Private hospital/clinic 
 
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 PULLALAREVU DIVYA SAI  Sri Rajiv Gandhi College of Dental Sciences and Hospital  Department of periodontics, Room no 12, Sri Rajiv Gandhi College of Dental sciences, RT Nagar Post Bengaluru , 560032 Department of periodontics, Room no 12, Sri Rajiv Gandhi College of Dental sciences, RT Nagar Post Bengaluru , 560032
Bangalore Rural
KARNATAKA 
06363364509

divyasaipullalarevu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethical Committee Sri Rajiv Gandhi College of Dental Sciences and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Omnident Toothpaste  15 subjects Will receive Omnident ® toothpaste containing sodium monoflu-orophosphate, Triclosan, Zinc sulphate, & Alum. Subjects in both groups will be advised to brush twice daily for 2 minutes using the Modified Bass brushing technique with the prescribed toothpaste by taking a peanut-sized amount and a soft bristle toothbrush for 21 days.  
Comparator Agent  Stolin R Toothpaste  15 patients will receive Stolin R ® toothpaste containing sodium monoflurophosphate, zinc sulphate, and Alum. Subjects in both groups will be advised to brush twice daily for 2 minutes using the Modified Bass brushing technique with the prescribed toothpaste by taking a peanut-sized amount and a soft bristle toothbrush for 21 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Individuals with at least 20 natural teeth.
subjects with a gingival index greater than 1 (as measured by Loe and Silness, 1963)
subjects with a plaque index of greater than 1 (as measured by the plaque index by Silness J, Loe H-1964).
 
 
ExclusionCriteria 
Details  Subjects with known systemic disease.
Patients under anti-inflammatory, antibiotic, or antimicrobial therapy in
the past 6 months.
Smokers and smokeless tobacco users.
Patients who have undergone periodontal treatment in the past 6 months.
Pregnant women and lactating mothers.
Subjects who are allergic to any material used in the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Bleeding on probing (BOP) (Ainamo J, Bay I -1975)
 

baseline, 7 days and 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival index (GI) (Loe H, Silness J) 1963
Plaque index (PI) (Silness J, Loe H) 1964
 
baseline, 7 days and 21 days. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 4 
Date of First Enrollment (India)   16/03/2026 
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="0"
Months="3"
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  

Plaque induced gingivitis is the second most common oral disease after dental caries. It is thought to affect at least 75% of the population worldwide. Gingivitis begins in the childhood and its prevalence increases with age. It has been reported that plaque induced gingivitis is seen in dentate individuals of all age group. Self-performed mechanical plaque removal is a proven method of controlling plaque and gingival disease. However, tooth brushing and flossing are difficult tasks and depend on individual dexterity.

Several chemical preventive agents have beneficial effects in the control of plaque and to reduce or prevent oral disease. Hence, various chemical formulations were tried in dentifrices. Chemicals, mainly triclosan and chlorhexidine, have been added in mouth rinses and dentifrices to prevent plaque and gingivitis.

Oral hygiene includes any or all of the procedures that contribute to a state of good oral health. To achieve improved oral health, many techniques and products are available nowadays, such as toothbrushes, rinses, floss, and dentifrices. The commonly used dentifrices are synthetic and contain chemical agents that are known to produce harmful side effects with prolonged use.

Chlorhexidine is one of the most effective supragingival plaque control agents. However, in a toothpaste preparation, a significant reduction of its antiplaque potential may be observed. Triclosan has also shown a significant reduction in plaque and gingivitis. Additional research is required for antimicrobial dentifrices that are comparatively less abrasive in controlling bacterial plaque. Controlled clinical trials have demonstrated that brushing teeth with dentifrices reduces supragingival plaque as well as gingivitis.

It is commonly observed that daily brushing often fails to achieve optimum gingival health Data from India show that every second person above the age of 35 years has gum pockets and 35% of total teeth extracted after the age of 35 years are due to periodontal disease. Prevalence of gingivitis in India is 80-90%. Triclosan (2,4,4’ trichlor-2’-hydroxydiphenyl ether) is a non-ionic chlorinated bisphenol widely used in personal Products such as deodorants and soaps and appears to be safe, effective and well tolerated.

It is compatible with toothpaste components such as fluoride and surfactants and, by virtue of its inhibition of cyclo-oxygenase/lipoxygenase pathways, is also anti-inflammatory. However, triclosan per se has only moderate substantivity and is not retained sufficiently long to have a significant antibacterial effect. Studies have shown that triclosan combined with CoPolymer PVM/MA or PPI has higher retention and substantivity. However, the benefit of short term and routine use of triclosan  dentifrices on reduction of gingivitis is not studied.   

The need for the study arises to compare the effect of two dentifrices with and without triclosan against plaque and gingivitis.                          


 
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