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.

Study Overview

• Status: Completed
• Conditions: Pit and Fissure Sealants; Dental Caries Prevention
• Intervention / Treatment: Other: Pit and fissure sealant (Conseal F)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia Governorate
    • Ismailia, Ismailia Governorate, Egypt, 41522
      • Faculty of Dentistry, Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

A- Patient inclusion criteria:

1. Cooperative, apparently healthy children.
2. Each child had at least three fully erupted first and/or second permanent molars.
3. Patient being at high risk of dental caries.
4. Informed consent was filled before treatment.

B- Molar inclusion criteria:

1. Tooth had deep pits and fissures.
2. Molars with the International Caries Detection and Assessment System (ICDAS) score 0-2.
3. All three molars required PFS.

Exclusion Criteria:

A- Patient exclusion criteria:

1. Uncooperative children.
2. Children with special needs.
3. Children who required emergency dental care (draining sinus, abscess and cellulitis).
4. Who were suffering from an allergy to latex or a severe gag reflex.
5. Mouth breather or child with nasal obstruction.
6. Children with fixed orthodontic.

B- Molar exclusion criteria:

1. Previous restored or carious first or second permanent molars.
2. Molars with anomalies of the enamel or dentin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Dry-Shield Isolation; Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design.	Other: Pit and fissure sealant (Conseal F); 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.
Active Comparator: Group 2: Rubber Dam Isolation; Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design.	Other: Pit and fissure sealant (Conseal F); 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.
Active Comparator: Group 3: Cotton Roll Isolation; Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design	Other: Pit and fissure sealant (Conseal F); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sealant Retention Rate	Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months.	6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chairside Time	Assessment of the time required for fissure sealant application using each isolation technique	Immediately during procedure
Patient Preference and discomfort	Assessment of patient preference and discomfort using a questionnaire and Wong-Baker FACES pain rating scale after fissure sealant placement	Immediately after procedure

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Actual): April 29, 2026
• Study Completion (Actual): May 8, 2026

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric Dentistry; Isolation System; Dry-Shield; Rubber Dam; Sealant Retention
• Additional Relevant MeSH Terms: Van der Woude syndrome; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dental Materials; Pit and Fissure Sealants
• Other Study ID Numbers: SCU-PEDO-RCT-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect patient privacy and maintain confidentiality, individual participant data will not be made publicly available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No