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Completed

NCT Number: NCT07622173

Dry-Shield vs Rubber Dam During Fissure Sealant Placement

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Sealant Retention Rate

    Time frame: 6 months and 12 months

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

Secondary outcomes

  1. Chairside Time

    Time frame: Immediately during procedure

    Assessment of the time required for fissure sealant application using each isolation technique

  2. Patient Preference and discomfort

    Time frame: Immediately after procedure

    Assessment of patient preference and discomfort using a questionnaire and Wong-Baker FACES pain rating scale after fissure sealant placement

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Efficiency of Using Dry-Shield and Rubber Dam Isolation on Fissure Sealant Application in Permanent Molars: A Randomized Clinical Trial

Acronym: DRY-SEAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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