Pit and Fissure SealantsDRY-SEALNCT07622173
Dry-Shield vs Rubber Dam During Fissure Sealant Placement
A study testing Pit and fissure sealant (Conseal F) in people with Pit and Fissure Sealants and Dental Caries Prevention, run by Suez Canal University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit and Fissure Sealants, Dental Caries Prevention
- What is being tested?
- Pit and fissure sealant (Conseal F)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2025to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
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- Tooth had deep pits and fissures.
- Molars with the International Caries Detection and Assessment System (ICDAS) score 0-2.
- All three molars required PFS.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Suez Canal University
Ismailia, Ismailia Governorate, 41522
About this study
Official title: 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.
Read the 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.
- Conditions
- Pit and Fissure Sealants, Dental Caries Prevention
- Being tested
- Pit and fissure sealant (Conseal F)
- Keywords
- Isolation System, Dry-Shield, Rubber Dam, Pediatric Dentistry, Sealant Retention
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dry-Shield Isolation | Experimental | Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design. Receives: 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. Receives: 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 Receives: Other: Pit and fissure sealant (Conseal F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant Retention Rate
Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months.
Measured: 6 months and 12 months
Secondary outcomes (2)
Chairside Time
Assessment of the time required for fissure sealant application using each isolation technique
Measured: 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
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start26 Feb 2025
- Primary completion29 Apr 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pit and Fissure SealantsStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622173
- Sponsor's protocol ID
- SCU-PEDO-RCT-2025
- Acronym
- DRY-SEAL
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect patient privacy and maintain confidentiality, individual participant data will not be made publicly available
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Using Dry-Shield and Rubber Dam Isolation on Fissure Sealant Application in Permanent Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07622173
- Acronym / sponsor ID
- DRY-SEAL / SCU-PEDO-RCT-2025
- Conditions
- Pit and Fissure Sealants, Dental Caries Prevention
- Keywords
- Isolation System, Dry-Shield, Rubber Dam, Pediatric Dentistry, Sealant Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dry-Shield Isolation | Experimental | Other: Pit and fissure sealant (Conseal F)Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design. |
| Group 2: Rubber Dam Isolation | Active comparator | Other: Pit and fissure sealant (Conseal F)Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design. |
| Group 3: Cotton Roll Isolation | Active comparator | Other: Pit and fissure sealant (Conseal F)Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group 1: Dry-Shield Isolation, Group 2: Rubber Dam Isolation, Group 3: Cotton Roll Isolation |
Primary outcome
Sealant Retention Rate
Time frame: 6 months and 12 months
Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months.
2 secondary outcomes
Chairside Time
Time frame: Immediately during procedure
Patient Preference and discomfort
Time frame: Immediately after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. To protect patient privacy and maintain confidentiality, individual participant data will not be made publicly available
Related trials for Pit and Fissure Sealants
Active, not recruiting
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
Dental Caries, Fissure Sealant
Not yet recruiting
Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
Pit and Fissure Sealant Retention, Dental Caries
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
Active, not recruiting
One-year Survival of Fissure Sealants in Immature Permanent Molars
Evaluation of the Survival of Different Fissure Sealants in Partially Erupted Immature Molar Teeth at Various Eruption Stages
Not yet recruiting
A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars
Pits and Fissure Sealants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pit and fissure sealant (Conseal F) in people with Pit and Fissure Sealants and Dental Caries Prevention, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sealant Retention Rate (time frame: 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.