Dental Caries, Insufficient Dental Filling
Conditions
Brief summary
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
DEVICEFast curing mode
Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).
DEVICEConventional curing mode
Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Split-mouth design: each patient receives 2 dental fillings (test and control treatment in the same patient)
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 4-10 days after placement of the dental fillings | The assessment of postoperative pain will be done by using the Wong-Baker Faces Pain rating Scale and includes questions about type and duration of pain, intensity of pain and the type of stimulus causing the pain. Values of 0 and 2 in the Wong-Baker Faces Pain Rating Scale are considered as no pain and values \>2 as pain. |
Countries
Switzerland
Outcome results
None listed