Trial record 21 of 163 for:    sodium fluoride

Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LO, Edward Chin Man, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01829334
First received: April 8, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.

The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.

The specific study objectives are:

  1. to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
  2. to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
  3. to compare the cost-effectiveness of the above four caries prevention methods.

Condition Intervention Phase
Dental Caries
Other: ART dental sealant
Other: Resin dental sealant
Other: Sodium fluoride varnish
Other: Silver fluoride solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • dental caries [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    development of carious cavity after 3 years


Enrollment: 329
Study Start Date: June 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Resin dental sealant
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
Other: Resin dental sealant
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
Experimental: ART dental sealant
ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
Other: ART dental sealant
ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
Experimental: Sodium fluoride varnish
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
Other: Sodium fluoride varnish
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
Experimental: Silver fluoride solution
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
Other: Silver fluoride solution
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months

  Eligibility

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • school children in good general health
  • has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries

Exclusion Criteria:

  • children with major systemic disease or on long-term medication
  • children not cooperative and refuse dental treatments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829334

Locations
China
Primary schools
Shenzhen, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Edward CM Lo The University of Hong Kong
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LO, Edward Chin Man, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01829334     History of Changes
Other Study ID Numbers: UW 06-203
Study First Received: April 8, 2013
Last Updated: April 8, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
dental caries

Additional relevant MeSH terms:
Fluorides
Sodium Fluoride
Listerine
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 16, 2014