search
Back to results

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

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
toothpaste 1 with maximum fluoride concentration
toothpaste 2 with 1000 ppm of fluoride
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring fluoride, dental caries, prevention

Eligibility Criteria

12 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shaheen Public SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

toothpaste 1

toothpaste 2

Arm Description

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 9, 2013
Last Updated
August 11, 2014
Sponsor
Dow University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02016001
Brief Title
Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention
Acronym
DMFT
Official Title
Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
fluoride, dental caries, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
toothpaste 1
Arm Type
Experimental
Arm Description
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
Arm Title
toothpaste 2
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
toothpaste 1 with maximum fluoride concentration
Other Intervention Name(s)
locally available tooth paste
Intervention Description
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
Intervention Name(s)
toothpaste 2 with 1000 ppm of fluoride
Other Intervention Name(s)
locally manufactured toothpaste
Intervention Description
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
Primary Outcome Measure Information:
Title
changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Aeeza Malik, BDS
Phone
0092-3126857665
Email
draeezamalik@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Malik Saleem, BDS, MSc
Phone
0092-3334710057
Email
malik_ss79@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ambrina Qureshi, BDS, M-Phil
Organizational Affiliation
Head of Community Department, Dow University of Health Sciences, Karachi, Pakistan
Official's Role
Study Director
Facility Information:
Facility Name
Shaheen Public School
City
Karachi
State/Province
Sindh
ZIP/Postal Code
0072
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Aeeza Malik, BDS

12. IPD Sharing Statement

Citations:
PubMed Identifier
20091655
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/20091655
Description
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;1.

Learn more about this trial

Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention

We'll reach out to this number within 24 hrs