Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention

Study Overview
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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.

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).

Official Title
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Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Other: toothpaste 1 with maximum fluoride concentration
* Other: toothpaste 2 with 1000 ppm of fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Regular school children of 12-15 years Presence of at least four molars Exclusion Criteria: Non- consenting cases Medically/physically compromised children Children under any kind of parallel fluoride regime (systemic or topical) Children consuming diet that is different from routine dietary practices Children using toothpaste with greater than 1100 ppm and less than 500 ppm of fluoride Children found with rampant caries Children found with all filled molars Children with any oral infection abscess, periodontitis etc Dentition with malocclusion Children undergoing orthodontic/prosthodontic treatment Children with Temporo mandibular joint disorder Children who missed the baseline examinations Loss to any follow-up cases

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: toothpaste 1<br>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 | Other: toothpaste 1 with maximum fluoride concentration<br>* 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<br>* Other names: locally available tooth paste;|
| Experimental: toothpaste 2<br>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 | Other: toothpaste 2 with 1000 ppm of fluoride<br>* 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<br>* Other names: locally manufactured toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluoride, dental caries, prevention