Effectiveness of Sealing Dental Caries
Effectiveness of Sealing Dental Caries: a Randomized Clinical Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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Comparatore attivo: 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
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of radiographic caries progression in the test group in comparison with the control group
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Longevity of resin composite used as sealants to restore dental caries
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AGA-0001
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