Dry-Shield vs Rubber Dam During Fissure Sealant Placement (DRY-SEAL)
Efficiency of Using Dry-Shield and Rubber Dam Isolation on Fissure Sealant Application in Permanent Molars: A Randomized Clinical Trial
This randomized clinical trial aims to evaluate the efficiency of the Dry-Shield isolation system compared with rubber dam isolation and cotton roll isolation during fissure sealant application in permanent molars among pediatric patients.
The study evaluates chairside time, patient preference, and fissure sealant retention rates after 6 and 12 months of follow-up. Proper isolation during fissure sealant application is considered essential for optimal retention and long-term clinical success.
The study also aims to assess whether Dry-Shield can provide a practical and comfortable alternative to conventional isolation techniques in pediatric dentistry.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Fissure sealants are widely used preventive measures for reducing occlusal caries in permanent molars. Successful sealant retention largely depends on adequate moisture control during application. Rubber dam isolation has traditionally been considered the gold standard for moisture control; however, its use in pediatric dentistry may be associated with increased chair time and patient discomfort.
Dry-Shield is an isolation device that combines suction, tongue retraction, bite block support, and moisture control in a single system. This may improve clinical efficiency and patient comfort during dental procedures.
This randomized clinical trial compares the Dry-Shield isolation system with rubber dam isolation and cotton roll isolation during fissure sealant application in permanent molars in children. The study evaluates clinical efficiency through assessment of chairside time, patient preference, and fissure sealant retention at 6 and 12month follow-ups.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egitto, 41522
- Faculty of Dentistry, Suez Canal University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
Inclusion Criteria:
A- Patient inclusion criteria:
- Cooperative, apparently healthy children.
- Each child had at least three fully erupted first and/or second permanent molars.
- Patient being at high risk of dental caries.
- Informed consent was filled before treatment.
B- Molar inclusion criteria:
- Tooth had deep pits and fissures.
- Molars with the International Caries Detection and Assessment System (ICDAS) score 0-2.
- All three molars required PFS.
Exclusion Criteria:
A- Patient exclusion criteria:
- Uncooperative children.
- Children with special needs.
- Children who required emergency dental care (draining sinus, abscess and cellulitis).
- Who were suffering from an allergy to latex or a severe gag reflex.
- Mouth breather or child with nasal obstruction.
- Children with fixed orthodontic.
B- Molar exclusion criteria:
- Previous restored or carious first or second permanent molars.
- Molars with anomalies of the enamel or dentin.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Group 1: Dry-Shield Isolation
Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design.
|
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
|
|
Comparatore attivo: Group 2: Rubber Dam Isolation
Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design.
|
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
|
|
Comparatore attivo: Group 3: Cotton Roll Isolation
Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design
|
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sealant Retention Rate
Lasso di tempo: 6 months and 12 months
|
Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months.
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6 months and 12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Chairside Time
Lasso di tempo: Immediately during procedure
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Assessment of the time required for fissure sealant application using each isolation technique
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Immediately during procedure
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Patient Preference and discomfort
Lasso di tempo: Immediately after procedure
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Assessment of patient preference and discomfort using a questionnaire and Wong-Baker FACES pain rating scale after fissure sealant placement
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Immediately after procedure
|
Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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
- SCU-PEDO-RCT-2025
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