NCT06608563 The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
| NCT ID | NCT06608563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Dublin, Trinity College |
| Condition | Dental Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-06-05 |
| Primary Completion | 2025-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-06-05 with a primary completion date of 2025-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Resin-based fissure sealants (FS) are recommended to prevent pit-and-fissure caries development or prevent the progression of enamel caries lesion to frank cavitation into dentine. There is still limited clinical evidence on the use of adhesive system beneath fissure sealants in permanent molars and its effect on FS retention and caries progression. Aim: The aim of this randomised clinical trial is to evaluate the clinical efficacy of fissure sealants placed with and without prior use of an adhesive system in terms of retention and caries prevention in permanent molars over the period of 2 years. Study design: Children (6-12 years of age) with high caries risk that require sealants in their first permanent molars (ICDAS 0-3) will be selected at the Dublin Dental University Hospital (DDUH). Molars will be stratified according to presence of caries lesions (ICDAS 0 or ICDAS1-3) and randomly allocated according to the study groups (Test group: 17% phosphoric acid + adhesive system + FS; Control group: 17% phosphoric acid + FS). The randomisation unit will be the tooth and more than one tooth can be included per child. All children will be evaluated after 12 and 24 months by calibrated independent examiners. The primary outcome of the present trial is sealant retention over time. Clinical variables such as age, gender, tooth position (upper/lower), caries experience (DMFT/dmft), stage of eruption (erupted/partially erupted) and children's behavior (Frankl scale) will be collected.
Eligibility 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
Contact & Investigator
Rona Leith
PRINCIPAL INVESTIGATOR
DDUH - Trinity College Dublin
Frequently Asked Questions
Who can join the NCT06608563 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06608563 currently recruiting?
Yes, NCT06608563 is actively recruiting participants. Contact the research team at rona.leith@dental.tcd.ie for enrollment information.
Where is the NCT06608563 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT06608563 clinical trial?
NCT06608563 is sponsored by University of Dublin, Trinity College. The principal investigator is Rona Leith at DDUH - Trinity College Dublin. The trial plans to enroll 100 participants.