Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention (DMFT)

August 11, 2014 updated by: DRAEEZA MALIK, Dow University of Health Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 0072
        • Recruiting
        • Shaheen Public School
        • Principal Investigator:
          • Dr. Aeeza Malik, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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
Other Names:
  • locally available tooth paste
Experimental: 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
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
Other Names:
  • locally manufactured toothpaste

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Study Director: Dr. Ambrina Qureshi, BDS, M-Phil, Head of Community Department, Dow University of Health Sciences, Karachi, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

November 9, 2013

First Submitted That Met QC Criteria

December 14, 2013

First Posted (Estimate)

December 19, 2013

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • draeezamalik
  • DUHS (Other Identifier: DUHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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