- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01829334
Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
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:
- 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,
- to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
- to compare the cost-effectiveness of the above four caries prevention methods.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
-
Shenzhen, Kina
- Primary schools
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Resin dental sealant
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
|
Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
|
Eksperimentel: 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
|
ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
|
Eksperimentel: Sodium fluoride varnish
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
|
Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
|
Eksperimentel: Silver fluoride solution
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
|
Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
dental caries
Tidsramme: 3 years
|
development of carious cavity after 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Edward CM Lo, The University of Hong Kong
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UW 06-203
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