Dry-Shield vs Rubber Dam During Fissure Sealant Placement

NCT07622173 | Completed

• 1 other identifier: SCU-PEDO-RCT-2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries Prevention; Pit and Fissure Sealants

Keywords

Isolation System; Dry-Shield; Rubber Dam; Pediatric Dentistry; Sealant Retention

Outcome Measures

Primary Outcomes (1)

• Sealant Retention Rate

  Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months.

  6 months and 12 months

Secondary Outcomes (2)

• Chairside Time

  Immediately during procedure

• Patient Preference and discomfort

  Immediately after procedure

Study Arms (3)

Group 1: Dry-Shield Isolation

EXPERIMENTAL

Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design.

Other: Pit and fissure sealant (Conseal F)

Group 2: Rubber Dam Isolation

ACTIVE COMPARATOR

Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design.

Other: Pit and fissure sealant (Conseal F)

Group 3: Cotton Roll Isolation

ACTIVE COMPARATOR

Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design

Other: Pit and fissure sealant (Conseal F)

Interventions

Pit and fissure sealant (Conseal F) OTHER

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.

Group 1: Dry-Shield Isolation; Group 2: Rubber Dam Isolation; Group 3: Cotton Roll Isolation

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry, Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

Location

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

Pit and Fissure Sealants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a three-arm, split-mouth randomized clinical trial involving 30 pediatric patients aged from 6 to 15 years, with a total of 90 first and/or second permanent molars indicated for pit and fissure sealants. Each participant acts as their own control, with their three eligible molars randomly allocated in a 1:1:1 ratio to receive the fissure sealants under three different isolation techniques: Group 1 (DryShield isolation system), Group 2 (rubber dam isolation), and Group 3 (cotton roll isolation).

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 3, 2026
• Study Start: February 26, 2025
• Primary Completion: April 29, 2026
• Study Completion: May 8, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)