Fast versus standard light-curing for composite fillings in baby molars
A Multi-center, Randomized-controlled, 12-month, Split-mouth, Non-inferiority Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy With a Flowable Bulk Fill Composite in Class I and II Deciduous Teeth
NA · Ivoclar Vivadent AG · NCT07212660
This test tries whether a very quick 5-second high-intensity light cure or the usual 10-second cure is safe and works well for composite fillings in primary molars in young children.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | Ivoclar Vivadent AG (industry) |
| Locations | 2 sites (Herzogenbuchsee, Canton of Bern and 1 other locations) |
| Trial ID | NCT07212660 on ClinicalTrials.gov |
What this trial studies
This interventional comparison enrolls children who need direct posterior composite restorations in primary molars and treats teeth with either a fast curing mode (5 seconds at 2000 mW/cm²) or a conventional curing mode (10 seconds at 1200 mW/cm²) using a flowable composite. Treatments are performed in routine dental clinic settings and clinical performance and safety of the restorations are followed over time. The trial targets common practical issues in pediatric dentistry, such as limited cooperation and moisture control, by shortening light-curing time in the experimental arm. Outcomes will include restoration survival, clinical performance measures and any adverse events related to the materials or procedures.
Who should consider this trial
Good fit: Ideal candidates are children whose legal guardians consent and who have two deciduous molars in different quadrants needing class I or II direct fillings and who can cooperate during treatment.
Not a fit: Children with active severe tooth pain, badly resorbed roots, need for direct pulp therapy or pulpotomy, allergies to study materials or anaesthetics, or who cannot be adequately isolated or are noncompliant are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, children could receive safe composite fillings with much shorter chair time, reducing stress and improving comfort during dental visits.
How similar studies have performed: High-intensity, short-duration light-curing has been explored in other dental settings and some reports suggest comparable immediate outcomes, but long-term data specifically in primary molars are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consent of a legal representative (usually parents) * 2 deciduous molars in the need of direct filling therapy class I and/or II in different quadrants (primary or secondary caries, filling loss) * Classification of caries: caries of all sizes in deciduous molars are included unless they can be treated with fissure sealing (ICDAS 3, 4, 5) * Sufficient language skills of legal representative and children * Teeth in the need of indirect pulp capping if necessary (Operator decision) Exclusion Criteria: * Cognitive impairment not age-appropriate * Sensitive tooth (pain at night, irritation-persistent pain, buccal swelling, percussion sensitivity) * Teeth with severely resorbed roots (anormal tooth mobility) * Direct pulp capping * Pulpotomy of an adjacent tooth in the same appointment * Noncompliant child * Allergies to material or anaesthetics used in the study * Sufficient isolation not possible
Where this trial is running
Herzogenbuchsee, Canton of Bern and 1 other locations
- N|DENT Zahnarztpraxis — Herzogenbuchsee, Canton of Bern, Switzerland (RECRUITING)
- Zahnarztpraxis Chrüzhof — Willisau, Canton of Lucerne, Switzerland (RECRUITING)
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.
Conditions: Dental Caries, Insufficient Dental Filling