Actively Recruiting
Comparing Two Curing Modes for Composite Fillings in Primary Teeth: A 12-Month Randomized Controlled Trial
Led by Ivoclar Vivadent AG · Updated on 2026-03-25
70
Participants Needed
2
Research Sites
47 weeks
Total Duration
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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 mW/cm², or a conventional curing mode, which takes 10 seconds at 1200 mW/cm². 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment visit
Participants receive direct filling therapy on primary teeth using either a fast curing mode or a conventional curing mode for composite restorations.
1 visit (in-person)
Duration - 4 to 10 days after treatment
Participants are monitored for postoperative pain and clinical performance of the dental fillings.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
1
N|DENT Zahnarztpraxis
Herzogenbuchsee, Canton of Bern, Switzerland, 3360
Actively Recruiting
2
Zahnarztpraxis Chrüzhof
Willisau, Canton of Lucerne, Switzerland, 6130
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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