Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dry-Shield Isolation | Experimental | Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design. |
|
| Group 2: Rubber Dam Isolation | Active Comparator | Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design. |
|
| Group 3: Cotton Roll Isolation | Active Comparator | Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
A- Patient inclusion criteria:
B- Molar inclusion criteria:
Exclusion Criteria:
A- Patient exclusion criteria:
B- Molar exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Suez Canal University | Ismailia | Ismailia Governorate | 41522 | Egypt |
To protect patient privacy and maintain confidentiality, individual participant data will not be made publicly available
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C536528 | Van der Woude syndrome |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010895 | Pit and Fissure Sealants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Immediately after procedure |