Dental Caries Prevention, Pit and Fissure Sealants
Conditions
Keywords
Isolation System, Dry-Shield, Rubber Dam, Pediatric Dentistry, Sealant Retention
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.
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.
Interventions
OTHERPit 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.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sealant Retention Rate | 6 months and 12 months | Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chairside Time | Immediately during procedure | Assessment of the time required for fissure sealant application using each isolation technique |
| Patient Preference and discomfort | Immediately after procedure | Assessment of patient preference and discomfort using a questionnaire and Wong-Baker FACES pain rating scale after fissure sealant placement |
Countries
Egypt
Outcome results
None listed