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
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring fluoride, dental caries, prevention
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
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
NCT ID
NCT02016001
First Posted
November 9, 2013
Last Updated
August 11, 2014
Sponsor
Dow University of Health Sciences
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.
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Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention
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