Evaluation of the longterm Clinical Performance of two Composites for the Restoration of Class II cavities
- Conditions
- K02Dental caries
- Registration Number
- DRKS00013564
- Lead Sponsor
- 3M Deutschland GmbH 3M Oral Care
- Brief Summary
For the 60-months-evaluation, 25 patients were available; four patients had terminated participation in the study and were considered a drop-out. In one patient, both restorations had failed due to secondary caries (SABF) at 36M and bulk fracture (FOBF) at 48M, and the patient was not recalled at 60M. After five years of clinical service, clinical success rate according to Kaplan Meier Survival analysis was 97% for FOBF and 98,6% for SABF restorations. One restoration failure due to secondary caries at 24M (conventional bulk fill FOBF) and one restoration failure due to secondary caries at 36M (self-adhesive bulkfill group SABF) were recorded. At 48M one restoration (FOBF) was recorded s failure due to bulk fracture of the marginal ridge. All other restorations revealed clinically fully acceptable FDI scores at all recalls. Regarding surface lustre and color match & translucency as well as regarding marginal staining FOBF performed significantly better than SABF at the 60 months evaluation. However, all restorations perform within an acceptable range. In conclusion, the novel tooth-colored self-adhesive bulk-fill restorative (SABF) exhibited clinically fully acceptable results over 60 months of clinical service, similarly to a conventional bulk-fill restorative (FOBF) used with a universal adhesive, but with slight shortcomings in esthetic properties. Therefore, both restorative materials may be recommended for clinical use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
1. Subject is between 18 and 75 years of age
2. Subject is in good general health (ASAa 1 or 2)
3. Subject does not have known allergies against any study substances
4. Subject is in need of a Class II restoration on at least 2 teeth
5. Both study teeth must have no increased tooth mobility (not more than 0-I).
6. Periodontal probing depth is =5.5 mm (CPITN explorer).
7. Both study teeth must have no signs of pulpitis,
8. Teeth with pulp exposure during treatment are excluded.
9. Study teeth are vital.
10. Level of oral hygiene is sufficient (PBI= 30%)
11. In case study restorations are in antagonistic contact with each other: each study restoration has at least one antagonistic occlusal contact to natural tooth substance
12. Subject does not suffer from bruxism (i.e. wears a mouth guard or should wear a mouth guard) or from traumatic malocclusion
13. Each study restoration has at least one proximal contact and is stress bearing.
14. Subject does not have excessive dietary or environmental exposure to acids or suffer from eating disorders (BEWE Index 0-I)
15. Subject is not pregnant or breast feeding at the time of placement of the restoration.
16. Subject volunteers to participate in the study and is available for recalls during the 3 years’ study duration (optional: 5y)
17. Subject does not participate in any other study at time of restoration placement.
1. Subject is not in good general health (ASA >2)
2. Subject does have known allergies against any study substances
3. Study teeth have increased tooth mobility (more than I).
4. Periodontal probing depth is greater than 5.5 mm (CPITN explorer).
5. One or both study teeth show signs of pulpitis,
6. Pulp exposure happens during restorative treatment during caries removal.
7. Study teeth are not vital or are endodontically treated.
8. Level of oral hygiene is not sufficient (PBI>30%)
9. In case study restorations are in antagonistic contact with each other: the study restorations have no antagonistic occlusal contact to natural tooth substance
10. Subject suffers from bruxism (i.e. wears a mouth guard or should wear a mouth guard) or from traumatic malocclusion
11. Subject does have excessive dietary or environmental exposure to acids or suffers from eating disorders (BEWE Index>I)
12. Study restorations have no proximal contact or are not stress bearing.
13. Subject is pregnant or breast feeding at the time of placement of the restoration.
14. Subject has not given written informed consent to participate and be available for the next 3 years.
15. Subject does participate in another study at time of restoration placement.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the restoration quality and clinical performance based on the FDI criteria (marginal integrity, marginal discoloration, fracture, wear, color match, hypersensitivities) at baseline and after 6 months as well as 1, 2 and 3 years.
- Secondary Outcome Measures
Name Time Method Evaluation of restoration survival based on recording of the respective FDI Criteria at the baseline, 6 months and 1, 2 and 3 year recalls and Kaplan Meier Survival Analysis after 3 years