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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Ägypten, 41522
- Faculty of Dentistry, Suez Canal University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Group 1: Dry-Shield Isolation
Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design.
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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.
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Aktiver Komparator: Group 2: Rubber Dam Isolation
Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design.
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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.
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Aktiver Komparator: Group 3: Cotton Roll Isolation
Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sealant Retention Rate
Zeitfenster: 6 months and 12 months
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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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Chairside Time
Zeitfenster: 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
Zeitfenster: 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
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SCU-PEDO-RCT-2025
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