Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-10-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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toothpaste 1

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

Group Type EXPERIMENTAL

toothpaste 1 with maximum fluoride concentration

Intervention Type OTHER

tooth paste 1 will be the tested intervention with maximum fluoride concentration (1500 ppm), which will be provided to the case group. They will brush the teeth twice daily for 2 minutes

toothpaste 2

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

Group Type EXPERIMENTAL

toothpaste 2 with 1000 ppm of fluoride

Intervention Type OTHER

tooth paste 2 will be the intervention with 1000ppm of fluoride, will be used by the control group. They will brush the teeth twice daily for 2 minutes

Interventions

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toothpaste 1 with maximum fluoride concentration

tooth paste 1 will be the tested intervention with maximum fluoride concentration (1500 ppm), which will be provided to the case group. They will brush the teeth twice daily for 2 minutes

Intervention Type OTHER

toothpaste 2 with 1000 ppm of fluoride

tooth paste 2 will be the intervention with 1000ppm of fluoride, will be used by the control group. They will brush the teeth twice daily for 2 minutes

Intervention Type OTHER

Other Intervention Names

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locally available tooth paste locally manufactured toothpaste

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes