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

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ClinicalTrials.gov Identifier: NCT02016001
Recruitment Status : Unknown
Verified August 2014 by DRAEEZA MALIK, Dow University of Health Sciences.
Recruitment status was:  Recruiting
First Posted : December 19, 2013
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
DRAEEZA MALIK, Dow University of Health Sciences

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

Condition or disease Intervention/treatment
Dental Caries Other: toothpaste 1 with maximum fluoride concentration Other: toothpaste 2 with 1000 ppm of fluoride

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  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial
Study Start Date : April 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

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 Name: 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 Name: locally manufactured toothpaste



Primary Outcome Measures :
  1. changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months. [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016001


Contacts
Contact: Dr. Aeeza Malik, BDS 0092-3126857665 draeezamalik@hotmail.com
Contact: Dr. Malik Saleem, BDS, MSc 0092-3334710057 malik_ss79@hotmail.com

Locations
Pakistan
Shaheen Public School Recruiting
Karachi, Sindh, Pakistan, 0072
Principal Investigator: Dr. Aeeza Malik, BDS         
Sponsors and Collaborators
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

Additional Information:
Publications:
Responsible Party: DRAEEZA MALIK, dr., Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT02016001     History of Changes
Other Study ID Numbers: draeezamalik
DUHS ( Other Identifier: DUHS )
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by DRAEEZA MALIK, Dow University of Health Sciences:
fluoride
dental caries
prevention

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs