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

Phase 2

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

Registration Number: CTRI/2017/12/010749

Lead Sponsor: adar Bhuvaneshwari G

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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