Comparison of toothpaste containing mango twig and market available toothpaste on oral bacteria and debris among 12-15 years old children in Davangere city.

Phase 2/3

Not yet recruiting

• Conditions: Unspecified infectious disease,

• Registration Number: CTRI/2019/01/016897

Brief Summary

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|This is a randomized, triple blinded, parallel group trial to evaluate the efficacy of dentifrices containing mangifera indica extract and fluoride   on salivary streptococcus mutans count and plaque accumulation   among 12 – 15 years school children in Davangere city.  A Two stage random sampling method will be followed for recruitment of participans. Sample size calculation  was done using G Power software by fixing the effect size at 0.4. **84 participants were equally divided into 3 groups containing test group , placebo group and control group.** Baseline and post-test assessment will be done after 3 weeks, for streptococcus mutans count and  Plaque score will be assessed by applying Turesky Gilmore Glickman modification of the Quigley Hein Plaque index. Comparison of salivary streptococcus mutans counts and plaque scores within group  will be done by Students paired ‘t’ test and  comparison of salivary streptococcus mutans counts and plaque score will be done at baseline and after 3 weeks  for three dentifrices  using one way ANOVA followed by post hoc Tukey’s test .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-12-27
• Study Start: 2019-01-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 1.Subjects whose parents will give consent for their children to participate in study.
• Subjects having at least one cavitated active carious lesion A cavitated active lesion – is a well-defined cavity with exposed dentin, yellowish or light brown in colour, which feels soft on gentle probing.
• Having a streptococcus mutans count of equal to or more than 105 CFU per ml of saliva (microbiological selection criteria) 4.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.
• Subjects with presence of more than 20 scoreable teeth in the oral cavity.

Exclusion Criteria

• Subjects on medications and subjects with systemic diseases that affect their salivary flow rate.
• 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.
• Subjects who will be unable to comply with the study appointment Schedules 5.
• Subjects using orthodontic appliances 6.
• Subjects using adjunctive oral hygiene aid like mouthwash.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess and compare the antiplaque and antibacterial efficacy of Mangifera indica extract dentifrice, commercially available Fluoridated dentifrice (Colgate total care) and a Placebo dentifrice on salivary Streptococcus mutans levels and plaque levels among 12 – 15 years old school children in Davanagere city	1.21 days after intervention

Trial Locations

Locations (1)

Bapuji Dental College and Hospital; 🇮🇳 Davanagere, KARNATAKA, India

Bapuji Dental College and Hospital

🇮🇳Davanagere, KARNATAKA, India

Dr Anindita Dutta

Principal investigator

9167119073

anindita.03.dutta@gmail.com