Clinical trial NCT02016001: Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention
Official title: Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: fluoride
dental caries
prevention
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 380
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Shaheen Public School
state: Sindh
Study officials:
affiliation: Head of Community Department, Dow University of Health Sciences, Karachi, Pakistan
name: Dr. Ambrina Qureshi, BDS, M-Phil
role: STUDY_DIRECTOR
References:
citation: Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.