- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
-
Shenzhen, Kina
- Primary Schools
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
dental caries
Tidsram: 3 years
|
development of carious cavity after 3 years
|
3 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Edward CM Lo, The University of Hong Kong
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UW 06-203
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