N/A
N=169
European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT01797458 ↗Enrolled (actual)
169
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Failure Rate of the Three Treatment Arms Judged Clinically — 37; 31; 39; 2 Teeth — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hall Technique (Procedure); Non-Restorative Caries Treatment (Procedure); Conventional Restoration (Procedure)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- University Medicine Greifswald
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Failure Rate of the Three Treatment Arms Judged Clinically |
37; 31; 39; 2; 9; 14 | 0.02 sig |
| SECONDARY Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction |
3; 1; 5 | — |
Summary
The purpose of this randomized clinical trial is to compare the clinical effectiveness of three treatments involving different caries management strategies (conventional restorations, Hall technique, and Non-Restorative Caries Treatment) to the management of class II carious primary molars in children (3-8 year-old).
Eligibility Criteria
Inclusion Criteria
- Children aged 3-8 years who attend the Preventive and Paediatric Department of Greifswald University, Germany.
(Lithuania: children who attend the paediatric dentistry department, Dental Faculty, Lithuanian University of Health Sciences)
- At least one primary molar tooth with caries into dentine involving two dental surfaces (diagnosed according to the International Caries Detection and Assessment System [ICDAS], codes 3 to 5)
- Willing to be examined
Exclusion Criteria
- Clinical or radiographic signs of pulpal or peri-radicular pathology
- Patients with a systemic disease requiring special considerations during their dental treatment.
- Parents/children who refuse to participate in the study
Data sourced from ClinicalTrials.gov (NCT01797458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.