Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention

Not Applicable

• Conditions: Dental Caries
• Interventions: Other: toothpaste 1 with maximum fluoride concentration; Other: toothpaste 2 with 1000 ppm of fluoride

• Registration Number: NCT02016001
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention after 18 months of randomized controlled trial.

Detailed Description

In developed countries, well-controlled clinical trials have investigated the effective fluoride level in toothpaste and provided irresistible data in relation to the caries controlling efficacy of tooth pastes. But there has been no such data reported in our part of the world. This indicates the need to determine the effective concentration of fluoride in locally manufactured tooth pastes for accomplishment of the goal of prevention against dental caries.

This will be a Parallel Group, Double-Blind, Randomized Controlled Trial, over a period of 18 months. The study will be conducted in a randomly selected school of Karachi city. Participants will be the cohort of regular school children aged 12-14 years. Sample size for the present study attained was 330 (165 in both groups), expected attrition rate will be kept as 15%, so the total sample size is 330 + 50 = 380 (190 in each group).

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-11-09
• Study First Submitted QC: 2013-12-14
• Study First Posted: 2013-12-19
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-11
• Last Update Posted: 2014-08-13
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

1. Regular school children of 12-15 years
2. Presence of at least four molars

Exclusion Criteria

1. Non- consenting cases
2. Medically/physically compromised children
3. Children under any kind of parallel fluoride regime (systemic or topical)
4. Children consuming diet that is different from routine dietary practices
5. Children using toothpaste with greater than 1100 ppm and less than 500 ppm of fluoride
6. Children found with rampant caries
7. Children found with all filled molars
8. Children with any oral infection abscess, periodontitis etc
9. Dentition with malocclusion
10. Children undergoing orthodontic/prosthodontic treatment
11. Children with Temporo mandibular joint disorder
12. Children who missed the baseline examinations
13. Loss to any follow-up cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
toothpaste 1	toothpaste 1 with maximum fluoride concentration	tooth paste 1 will be the tested intervention with maximum fluoride concentration (1500ppm), which will be provided to the case group. They will brush the teeth twice daily for 2 minutes
toothpaste 2	toothpaste 2 with 1000 ppm of fluoride	toothpaste 2 will be the intervention with 1000 ppm of fluoride, which will be used by control group. They will brush the teeth twice daily for 2 minutes

Primary Outcome Measures

Name	Time	Method
changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.	18 months

Trial Locations

Locations (1)

Shaheen Public School; 🇵🇰 Karachi, Sindh, Pakistan