Arresting Active Dental Caries in Preschool Children by Topical Fluorides

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT02426619

Collaborator

(none)

371

Enrollment

Location

Arms

30.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2012

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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 Names: 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 Names: 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 Names: sodium fluoride varnish

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 Names:

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

Other Names:

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 Names:

sodium fluoride varnish

Outcome Measures

Primary Outcome Measures

change in hardness of dental caries lesion [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Hong Kong	Hong Kong		China

Sponsors and Collaborators

The University of Hong Kong

Investigators

Principal Investigator: Edward CM Lo, BDS, PhD, Faculty of Dentistry, University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT02426619

Other Study ID Numbers:

UW12-490

First Posted:

Apr 27, 2015

Last Update Posted:

Mar 7, 2016

Last Verified:

Mar 1, 2016

Additional relevant MeSH terms:

Dental Caries

Pharmaceutical Solutions

Fluorides

Sodium Fluoride

Fluorides, Topical

Study Results

No Results Posted as of Mar 7, 2016