| 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
|
|
|
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
|
|
|
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. |