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Trial record 52 of 291 for:    Sodium Fluoride OR Duraphat

Arresting Active Dental Caries in Preschool Children by Topical Fluorides

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ClinicalTrials.gov Identifier: NCT02426619
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief Summary:
This randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% SDF solution at yearly or weekly interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months.

Condition or disease Intervention/treatment Phase
Dental Caries Device: SDF solution Device: NaF varnish Phase 2 Phase 3

Detailed Description:

This randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% SDF solution at yearly or weekly interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months.

Preschool children attending the first year of the kindergartens will be invited to join this study. An invitation letter will be sent to the parents explaining the purpose and procedures of this study. Parental consent will be sought. Generally healthy children who have at least one tooth with untreated caries into dentine will be invited to participate and they will be followed for 30 months.

Dental clinical examination of the children will be conducted by a calibrated dentist in the kindergarten. Tooth and oral hygiene condition will be recorded. A parental questionnaire will be administered at baseline and at the 30-month follow-up visits regarding their children's socio-economic background and oral health related behaviours. The questionnaire will also assess parental satisfaction with their child's oral health and dental aesthetics.

All active dental caries lesions of the participant children will be treated if possible. The children will be categorized as having a high or a low caries rate. They will then be allocated by a stratified randomization method to one of the three study groups:

Group A - 3 applications of a 30% SDF solution at yearly interval Group B - 3 applications of a 30% SDF solution at weekly interval Group C - 3 applications of a 5% NaF varnish at weekly interval

A dental operator who is not involved in the examination of the child will apply the fluoride agents. Follow-up oral examinations will be conducted every 6 months in the kindergartens for 30 months. The status of the treated teeth and any possible side/adverse effects will be recorded in the follow-up examinations.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial on the Use of Sodium Fluoride Varnish and Silver Diamine Fluoride Solution for Arresting Active Dental Caries in Preschool Children
Study Start Date : September 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SDF regular
3 applications of a 30% SDF solution will be applied onto the surface of dental caries lesions by a small brush regularly once a year
Device: SDF solution
around 1 mL of 30% silver diammine fluoride (SDF) solution is placed in a small disposable container and a small brush will be used to apply a very small quantity of the solution onto the surface of the dental caries lesion in the tooth
Other Name: silver diammine fluoride solution

Experimental: SDF intensive
3 applications of a 30% SDF solution will be applied onto the surface of dental caries lesions by a small brush at weekly interval at baseline
Device: SDF solution
around 1 mL of 30% silver diammine fluoride (SDF) solution is placed in a small disposable container and a small brush will be used to apply a very small quantity of the solution onto the surface of the dental caries lesion in the tooth
Other Name: silver diammine fluoride solution

Active Comparator: NaF varnish
3 applications of a 5% NaF varnish will be applied onto the surface of dental caries lesions by a small brush at weekly interval at baseline
Device: NaF varnish
around 1 mL of 5% NaF (sodium fluoride) varnish is placed in a small disposable container and a small brush will be used to apply a very small quantity of the solution onto the surface of the dental caries lesion in the tooth
Other Name: sodium fluoride varnish




Primary Outcome Measures :
  1. change in hardness of dental caries lesion [ Time Frame: baseline and 30 months ]
    change from a soft active dental caries lesion at baseline to a hardened arrested caries lesion upon gentle probing with a dental explorer at the evaluation is regarded as a positive treatment outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally healthy children who have at least one tooth with untreated caries into dentine

Exclusion Criteria:

  • Children who have major systemic diseases or on long-term medication, are uncooperative or refuse the treatment will be excluded.

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): NCT02426619


Locations
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China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Edward CM Lo, BDS, PhD Faculty of Dentistry, University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02426619     History of Changes
Other Study ID Numbers: UW12-490
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Fluorides, Topical
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents