Caries prevention during eruption of first permanent molars
Conditions
Interventions
Group 1: Arm 1 – Helioseal F Plus® (Resin-Based Sealant)
Each child receives Helioseal F Plus® (Ivoclar Vivadent) on one first permanent molar. The resin-based sealant is applied under dry condition
Sponsors
Poliklinik für Kinderzahnheilkunde, Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Age
5 Years to 8 Years
Inclusion criteria
Inclusion criteria: Children aged 5 to 8 years. Presence of at least two contralateral erupting first permanent molars suitable for fissure sealing. Good general health and cooperative behavior suitable for dental treatment. Written informed consent obtained from parents or legal guardians.
Exclusion criteria
Exclusion criteria: Systemic or chronic diseases that may affect oral health or dental development. Teeth with existing carious lesions, restorations, or developmental enamel defects. Uncooperative behavior preventing proper isolation or sealant application. Allergy or known intolerance to any component of the sealant materials. Children who have participated in another clinical study within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint (target criterion): Incidence of new carious lesions on the sealed first permanent molars. Time of assessment: Evaluated during follow-up visits at 6, 12, and 24 months after sealant application. Method of data collection: Clinical examination of the sealed molars according to the International Caries Detection and Assessment System (ICDAS) criteria. Assessments are performed by trained examiners during routine follow-up visits, and findings are documented on standardized clinical report forms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-term secondary endpoints (assessed on the day of sealant application): Child’s acceptance and compliance measured by the Wong-Baker FACES and Frankl Behaviour Rating scales. Application time (in minutes) for each sealant material. Patient and parent preferences regarding comfort, satisfaction, and willingness to repeat treatment. Clinician and assistant feedback on handling, ease of application, and overall experience. Extent of assistant support required during sealant placement. Influence of patient age on acceptance and application success. Influence of jaw location (maxillary vs. mandibular molars). Incidence of moisture control challenges recorded during the procedure. Immediate sealant retention directly after application. Cost assessment based on material use and statutory insurance (BEMA) valuation. Method of data collection: Structured questionnaires for children, parents, operators, and assistants; clinical evaluations by calibrated examiners using standardized forms and validated indices (Wong-Baker FACES, Frankl, ICDAS, Ryge) | — |
Countries
Germany
Contacts
Public ContactRuth Santamaria
Poliklinik für Kinderzahnheilkunde, Universitätsmedizin Greifswald
Outcome results
None listed