A clinical trial to study the effects of three toothpastes, 4% Tulsi extract, Colgate total and Placebo in 14 - 15 years school children having tooth decay, gum problems with presence of debris in oral cavity

â??Comparative evaluation of efficacy of 4% Tulsi, Fluoridated and Placebo dentifrices on Salivary Streptococcus Mutans count, Gingivitis and Plaque among 14 â?? 15 years school children in Davangere city â?? A Concurrent Parallel Trial ?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010749

Enrollment

Registered

2017-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Participants having active carious lesion with gingivitis and Plaque accumulation

Interventions

Intervention1: Test dentifrice - 4% Tulsi extract dentifrice: Composition include all the basic ingredients of toothpaste and therapeutic agent as Tulsi extract 4% concentration Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects who will give consent to participate 2.Subjects having atleast one cavitated active carious lesion 3.Having a streptococcus mutans count of equal to or more than 100000 CFU per ml of saliva (microbiological selection criteria) 4.Subjects with a baseline mean gingival index score of at least 1.0 as determined by the use of the Loe-Silness Gingival Index 5.Subjects with a baseline mean plaque index score of at least 1.5 as determined by the use of the Turesky modification of the Quigley-Hein Plaque Index. 6.Subjects with presence of more than 20 scoreable teeth in the oral cavity

Exclusion criteria

Exclusion criteria: 1.Subjects on medications and subjects with systemic diseases that affect their salivary flow rate 2.History of hypersensitivity to any product used in the study. 3.History of antibiotic therapy in the previous one month till the start of the study. 4.Subjects who will be unable to comply with the study appointment schedules 5.Subjects using orthodontic appliances

Design outcomes

Primary

Measure	Time frame
Primary outcome: Reduction in the salivary streptococcus mutans colony forming counts. Reduction in gingivitis and plaque scores assessed by Loe and silness and modified Quigley â?? Hein plaque index after the use of three dentifricesTimepoint: Reduction in the salivary streptococcus mutans colony forming counts assessed at baseline and after seven days. Reduction in gingivitis and plaque scores assessed by Loe and silness and modified Quigley â?? Hein plaque index at baseline and after 21 days after the use of dentifrices	—

Measure

Time frame

Primary outcome: Reduction in the salivary streptococcus mutans colony forming counts. Reduction in gingivitis and plaque scores assessed by Loe and silness and modified Quigley â?? Hein plaque index after the use of three dentifricesTimepoint: Reduction in the salivary streptococcus mutans colony forming counts assessed at baseline and after seven days. Reduction in gingivitis and plaque scores assessed by Loe and silness and modified Quigley â?? Hein plaque index at baseline and after 21 days after the use of dentifrices

—

Secondary

Measure	Time frame
Assessing the acceptability and safety of Tulsi extract dentifriceTimepoint: Acceptability and safety of Tulsi extract dentifrice will be assessed on 21st day	—

Countries

India

Contacts

Public ContactNadar Bhuvaneshwari G

Bapuji Dental College and Hospital, Davangere

drushe8@yahoo.in7829794198

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026