Evaluating the impact of an adhesive system on fissure sealants for children's molars
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars: a 2-year Randomised Clinical Trial
This study is testing whether using an adhesive with fissure sealants can better protect children's first permanent molars from cavities compared to using the sealants alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Dublin, Trinity College Academic / other |
| Locations | 1 site (Dublin, Dublin) |
| Trial ID | NCT06608563 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of fissure sealants applied with and without an adhesive system in preventing dental caries in children's first permanent molars. Children aged 6 to 12 years with a high risk of caries will be recruited from the Dublin Dental University Hospital. The study will randomly assign participants to receive either a fissure sealant alone or one applied after an adhesive system, monitoring retention and caries progression over two years. The trial seeks to provide clearer clinical evidence on the best practices for fissure sealant application.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 12 years with high caries risk and first permanent molars that are either caries-free or have early enamel lesions.
Not a fit: Patients with significant dental defects or those requiring restorative treatments on the selected molars may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of fissure sealants in preventing dental caries in children.
How similar studies have performed: While some studies have explored adhesive systems in dental applications, this specific approach to fissure sealants is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. 6 to 12 years of age; 2. Referred for dental treatment at the Dublin Dental University Hospital DDUH) or that are ongoing patients of the Paediatric dentistry clinic; 3. With first permanent molars that are caries free or present caries lesions restricted to enamel (ICDAS 1 to 3) indicated for glass ionomer sealants. 4. Whose parents agreed and consent to participate in the present research; Exclusion criteria: 1. Presence of any developmental defects 2. Presence of any type of restorative/sealant material in the selected tooth; 3. Presence of a dentine shadow (ICDAS 4) or dentine cavitation (ICDAS 5/6) detected clinically and/or radiographically14; 4. Insufficient cooperation to achieve adequate moisture control using cotton roll isolation
Where this trial is running
Dublin, Dublin
- Dublin Dental University Hospital - Trintiy College Dublin — Dublin, Dublin, Ireland (Recruiting)
Study contacts
- Principal investigator: Rona Leith — DDUH - Trinity College Dublin
- Study coordinator: Rona Leith, BDentSc DChDent
- Email: rona.leith@dental.tcd.ie
- Phone: +353 01 6127303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.