Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention

Dental Caries Clinical Trial

— DMFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02016001
• Other study ID #: draeezamalik
• Secondary ID: DUHS
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2013
• Last updated: August 11, 2014
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: Dow University of Health Sciences
• Contact: Dr. Aeeza Malik, BDS
• Phone: 0092-3126857665
• Email: draeezamalik[@]hotmail.com
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	Shaheen Public School	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.		18 months	No

External Links

•   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.