Dental Caries Clinical Trial
Official title:
Longevity of Dental Fillings by Chairside Technique Utilizing 3D Printing vs. Direct Composite Fillings
Verified date | November 2020 |
Source | University of Oulu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the present study is to compare the success of dental fillings prepared using 3D printing technique to those manufactured with the direct composite technique. A total of 100 adult patients will be selected from dental patients attending Kaarina Municipal Health Care Centre from October 2020. The inclusion criteria are as follows: presence of multiple cavities, fractures or cosmetic demands on bilateral permanent teeth. The restorative demand should be a class II, III or IV on first or second molars, or premolars. At least two fillings should be from the same tooth group (premolar/molar) in each patient. This will be a split-mouth study, whereby one tooth on one side will be restored using direct technique, and the contra lateral tooth restored using the indirect technique through random allocation. For both direct and indirect restorations, commercially available short-fibre reinforced composite material (Ever X Flow, GC) is used for core material (replacing dentin) and flowable composite material (Gaenial Universal Injectable, GC) for surface (replacing enamel, appr. 2mm thickness from the surface), according the manufacturer´s instructions. Clinical evaluations will be conducted immediately after the final finishing, and after 1 year, 3 years and 5 years. The evaluation will be based on the United States Public Health Service (USPHS) criteria. Descriptive statistics will be used to describe the frequency distributions of the evaluated criteria. To analyse the failure rate for direct vs. indirect restorations, 2x2 tables will be created. Non-parametric statistical procedures will be used due to ordinally structured data for the assessment of the restorations. Mann-Whitney U-test will be used to explore significant differences at different time points between direct and indirect restorations.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | December 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - presence of cavities, fractures or cosmetic demands - first or second molars and permanent premolars needing restorations - at least two class II restorations from the same tooth group (premolar/molar) should be performed in each patient - the number of restorations of each technique should be equal in each patient Exclusion Criteria: - pulp exposure or risk of it during caries removal or cavities with imminent risk of pulp exposure - spontaneous pain or sensitivity to percussion |
Country | Name | City | State |
---|---|---|---|
Finland | Research Unit of Oral Health Sciences, University of Oulu | Oulu |
Lead Sponsor | Collaborator |
---|---|
University of Oulu | Oulu University Hospital, University of Eastern Finland, University of Helsinki, University of Turku |
Finland,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The United States Public Health Service (USPHS) criteria; changes during the follow-up period | The USPHS criteria include the following evaluations: retention, postoperative sensitivity, secondary caries, colour match, anatomical form, marginal discoloration, marginal adaptation, and surface texture. This clinical assessment method results in ordinally structured data for the outcome variables (A, Alpha = excellent result; B, Bravo = acceptable result; C, Charlie = unacceptable, replacement of the restoration necessary). | baseline, and 1 year, 3 years and 5 years after baseline |
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