NCT06776471 Clinical Evaluation of Two Different Pit and Fissure Sealants
| NCT ID | NCT06776471 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baskent University |
| Condition | Pit and Fissure Sealants |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2025-11-18 |
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 126 participants in total. It began in 2024-11-18 with a primary completion date of 2025-11-18.
⚠ 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
It is planned to include girls and boys between the ages of 6-12 who apply to Başkent University Faculty of Dentistry, Pediatric Dentistry Clinic for routine dental examination. Informed and written consent will be obtained from the parents of each participating child. In teeth planned to undergo treatment, molar ıncisor hypomineralization diagnosis will be made primarily in the presence of limited opacities/enamel fracture after eruption in at least one first permanent molar according to European Academy of Paediatric Dentistry criteria. In teeth diagnosed with molar ıncisor hypominerlization, tooth surfaces will be cleaned with a slow-speed rotary brush and dried with air before the evaluations to be made using the ICDAS II index. Early enamel caries lesions will be assessed by visual examination. The decayed, missing, filled teeth of the patients will be assessed according to the World Health Organization assessment criteria. The groups will be double-blind randomized as conventional fissure sealant (n=63) and self-adhesive flowable composite (n=63): Group I (acid+resin-based fissure sealant) will be etched with 37% phosphoric acid for 30 seconds, the surface will be rinsed and air dried until an opaque appearance is achieved on the enamel. Low-viscosity fluoride containing resin based fissure sealant will be applied to the etched enamel surface. Group II (self-adhesive flowable composite); self adhesive flowable composite will be applied in one step. All applied fissure sealants will be polymerized using a light device. Finally, occlusion control will be performed on fissure sealants with articulation paper.The Schiff Cold Air Sensitivity Scale will be used to assess the presence of hypersensitivity in the affected teeth by applying the air-water spray perpendicular to the occlusal surface of the tooth from a distance of 1 cm for 1 second. Clinical evaluation of fissure sealants will be performed at 1, 3, 6 and 12 months using modified . Sealants that receive "Alpha" or "Bravo" scores for all criteria (anatomical form, marginal adaptation, surface texture, marginal color change, retention and secondary caries) will be classified as successful; while "Charlie" scores received from one or more of the United States Public Health Service criteria will be evaluated as failure.
Eligibility Criteria
Inclusion Criteria: * Healthy children aged 6-12 years with at least two fully erupted permanent first molars diagnosed with molar ıncisor hypomineralization according to the European Academy of Paediatric Dentistry criteria. * Hypomineralized first molars with enamel defects according to early lesions Exclusion Criteria: * Ongoing orthodontic treatment * Uncooperative child during dental treatment * Teeth with advanced lesions, existing restorations, fluorosis, or enamel malformation due to syndromic causes * Presence of pulpal symptoms
Contact & Investigator
Simge POLAT, Lecturer
PRINCIPAL INVESTIGATOR
Baskent University
Frequently Asked Questions
Who can join the NCT06776471 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Pit and Fissure Sealants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06776471 currently recruiting?
Yes, NCT06776471 is actively recruiting participants. Contact the research team at simgepolat@baskent.edu.tr for enrollment information.
Where is the NCT06776471 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT06776471 clinical trial?
NCT06776471 is sponsored by Baskent University. The principal investigator is Simge POLAT, Lecturer at Baskent University. The trial plans to enroll 126 participants.