What is this study studying for dental caries in children?

This study is evaluating two different curing methods for composite fillings in primary molars to see how they perform and how safe they are. The goal is to find out if a faster curing mode can reduce treatment time and help children during dental care. The research is sponsored by Ivoclar Vivadent AG.

Who may be eligible for this dental caries clinical trial?

Children aged 4 to 9 with two deciduous molars needing filling therapy may be eligible. Participants must have adequate language skills and no severe tooth pain or allergies to materials used. Both boys and girls can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this dental caries clinical trial?

Study-related care, including the dental fillings and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive study treatments without charge.

Actively Recruiting

Phase Not Applicable

Age: 4Years - 9Years

All Genders

ID07212660

A Randomized Clinical Trial Comparing Fast and Conventional Curing Modes for Composite Fillings in Primary Molars

Led by Ivoclar Vivadent AG · Updated on 2026-03-25

Participants Needed

Research Sites

47 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the clinical performance and safety of two different curing modes for composite resin restorations in primary molars of young children. The study focuses on children aged 4 to 9 years who need direct filling therapy on deciduous teeth. Dental treatment in young children is challenging due to anxiety and difficulty in moisture control, so reducing treatment time could benefit both children and dentists. Participants will receive composite restorations cured using either a fast curing mode, which takes 5 seconds at 2000 mWcm, or a conventional curing mode, which takes 10 seconds at 1200 mWcm. This is a randomized, double-blind, split-mouth clinical trial lasting 12 months. Each child will have two different molars treated with each curing mode in separate quadrants. During the study, children will be monitored for postoperative pain 4 to 10 days after treatment. The trial involves legal representative consent, assessments of treatment performance and safety, and evaluations of any complications or discomfort. The total participation time covers the full 12-month follow-up period to assess the long-term outcomes of the dental restorations.

CONDITIONS

Brief Title

A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth

Who Can Participate

Age: 4Years - 9Years

All Genders

Eligibility Criteria

You may qualify if you...

Consent of a legal representative (usually parents)
Two deciduous molars needing direct filling therapy class I and/or II in different quadrants
Caries of all sizes unless treatable with fissure sealing (ICDAS 3, 4, 5)
Sufficient language skills of legal representative and children
Teeth may need indirect pulp capping if necessary (Operator decision)

You will not qualify if you...

Cognitive impairment not age-appropriate
Sensitive tooth with pain at night, persistent irritation, buccal swelling, or percussion sensitivity
Teeth with severely resorbed roots or abnormal tooth mobility
Direct pulp capping
Pulpotomy of an adjacent tooth in the same appointment
Noncompliant child
Allergies to materials or anesthetics used in the study
Sufficient isolation not possible

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