Effectiveness of Sealing Dental Caries
Effectiveness of Sealing Dental Caries: a Randomized Clinical Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The present study will be carried out as a randomized clinical study. Primary, occlusal caries lesions in children, aged 3-8 years old will be treated by non-invasive resin based sealing (n= 50) or resin based restoration (n=50). Randomization between sealing and restoration (1:1) was made by for a resercher at the Federal University of Rio de Janeiro and kept at the clinics in sealed envelopes. The treatments will be examined clinically and radiographically after 6, 12, 24 and 36 years. The treatments are performed and controlled by only one practitioner (the main reseacher of this study) from the Federal University of Rio de Janeiro, Brazil.
Sealing: The dentist will use a resin based sealing, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from the Department of Pediatric Dentistry and Orthodontics of Federal University of Rio de Janeiro, Brazil.
Restoration: The dentist will use preparation design and a resin based resin restoration, and follow their usual clinical procedures (partial caries removal) based on the instructions from the manufacturer and the guidelines from Department of Pediatric Dentistry and Orthodontics of Federal University of Rio de Janeiro, Brazil.
The prevalence of regression, arrest and progression of sealed and restored caries lesions, are computed and related to the clinical and radiological registrations of children, or treatment related factors for assessing of statistically significant correlations.
The influence of each factor on the longevity and need for retreatment of occlusal sealants and restorations, will be assessed using apropriate analyses for statistical treatment of data.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Children with good general health; children with caries lesion reaching to the middle third of the dentin of primary molars
Exclusion Criteria:
- Patients with systemic diseases; patient' guardians who did not consent with the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Non-invasive resin based caries sealing
Application of resin based sealant after acid etching of carious occlusal surface
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The dentists use resin based sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil
Andere namen:
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Actieve vergelijker: Invasive resin based restoration
Application of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface
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The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Proportion of radiographic caries progression in the test group in comparison with the control group
Tijdsspanne: 36 months after the intervention
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Digital bitewing radiographs were taken at baseline and repeated after 6, 12, 24 and 36-months.
The radiographical scoring system that will be used is: 1) Regression in depth of lesion (success) 2: Unchanged depth of lesion (success) 3: Progression in depth of lesion (failure)
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36 months after the intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Longevity of resin composite used as sealants to restore dental caries
Tijdsspanne: 36 months after the intervention
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Clinical evaluation will be performed through clinical examination after 6, 12, 24 and 36-months.
The USPHS criteria for evaluating the marginal integrity of the restoration will be used.
Clinical scores: Alfa - Restoration showing continuity with the anatomical shape ; Bravo - Restoration discontinuous with the anatomical shape , but the loss of material is not enough to expose the floor of the cavity; Charlie - Restoration discontinuous with the anatomical shape and the loss of material is sufficient to expose the floor of the cavity; and Delta - mobile Restoration fractured or lost.
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36 months after the intervention
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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AGA-0001
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