Clinical Trials Logo
  1. Home
  2. Dental Caries
  3. NCT02592278
  4. Details
NCT02592278 Clinical Trial

Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

Dental Caries Clinical Trial

Official title:
Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02592278
Other study ID # 04-2015
Secondary ID
Status Completed
Phase Phase 4
First received October 28, 2015
Last updated November 2, 2016
Start date March 2015
Est. completion date March 2016

Study information
Verified date November 2016
Source Universidad Iberoamericana
Contact n/a
Is FDA regulated No
Health authority Dominican Republic: Consejo Nacional de Bioetica en Salud
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.

Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.

Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 7 Years
Eligibility Inclusion Criteria:

- Informed Consent from parents.

- Child assent

- High risk of dental caries

- At least one sound first permanent molar (ICDAS=0)

Exclusion Criteria:

- Bad behaviour

- Any systemic condition, disability

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Fluoride Varnish
Application of fluoride varnish every 3 and 6 months.
• Control Group
Twice a day brush with fluoride toothpaste.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Universidad Iberoamericana Colgate Palmolive

Outcome
Type Measure Description Time frame Safety issue
Primary Number of first permanent molars with caries Lesion (taking into account ICDAS criteria) We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year. One year No
See also
  Status Clinical Trial Phase
Completed NCT04127929 - Investigation of Glass Carbomer Performance N/A
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Active, not recruiting NCT04475679 - Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy N/A
Completed NCT05438381 - Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars N/A
Not yet recruiting NCT03037814 - Clinical Performance of Restorative Materials in Primary Teeth N/A
Active, not recruiting NCT05202665 - Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion N/A
Terminated NCT01147835 - Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers N/A
Not yet recruiting NCT04033263 - Maintaining Oral Health With Bio-products N/A
Enrolling by invitation NCT04438252 - Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions N/A
Not yet recruiting NCT03609034 - Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT02473107 - Impact of Detecting Initial and Active Caries Lesions in Primary Teeth N/A
Active, not recruiting NCT02537184 - Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children N/A
Completed NCT01950546 - Nanosilver Fluoride to Prevent Dental Biofilms Growth Phase 1
Recruiting NCT02734420 - Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial Phase 1
Completed NCT02020681 - Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions N/A
Completed NCT02426619 - Arresting Active Dental Caries in Preschool Children by Topical Fluorides Phase 2/Phase 3
Completed NCT02234609 - Effectiveness of Modified Class IV Atraumatic Restorative Treatment N/A
Completed NCT02019563 - MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial Phase 2