A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fast curing mode, Conventional curing mode.
- Who it may be relevant to
- Registry conditions: Dental Caries, Insufficient Dental Filling. Basic parameters: 4 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.
Detailed description
Dental interventions in young children are challenging due to limited compliance and anxiety. Moisture control during the placement of resin composite fillings is particularly difficult, as children need to remain calm. Reducing treatment time benefits both children and dentists.
The planned clinical investigation aims to evaluate the clinical performance and safety of posterior restorations on primary teeth using a flowable composite with a fast curing mode (5 seconds, 2000 mW/cm²) compared to a conventional curing mode (10 seconds, 1200 mW/cm²).
Interventions
- Device Fast curing mode
Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²). - Device Conventional curing mode
Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).
Primary outcome measures
- Postoperative pain [Time frame: 4-10 days after placement of the dental fillings]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Switzerland · 2 centers
- N|DENT Zahnarztpraxis — Herzogenbuchsee
- Zahnarztpraxis Chrüzhof — Willisau
Identifiers
NCT: NCT07212660 · OTCS 369512033