Trial Outcomes & Findings for Clinical Evaluation of a Dental Glass Ceramic (NCT NCT04933123)
NCT ID: NCT04933123
Last Updated: 2025-04-20
Results Overview
Inlay and onlay restorations were examined by a dentist
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Baseline (7-10 days after insertion of restoration)
Results posted on
2025-04-20
Participant Flow
The recruitment period lasted from 14.09.2021-15.11.2021 in the dental clinic.
Unit of analysis: Inlays/Onlays
Participant milestones
| Measure |
Inlay/Onlay
indirect restorative treatment with a glass ceramic: Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.
|
|---|---|
|
Overall Study
STARTED
|
13 13
|
|
Overall Study
COMPLETED
|
13 13
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Inlay/Onlay
n=13 Participants
indirect restorative treatment with a glass ceramic: Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.
|
|---|---|
|
Age, Customized
18-65 years old
|
13 participants
n=13 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Baseline (7-10 days after insertion of restoration)Inlay and onlay restorations were examined by a dentist
Outcome measures
| Measure |
Inlay/Onlay
n=13 Inlays/Onlays
indirect restorative treatment with a glass ceramic: Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.
|
|---|---|
|
Survival Rate of Inlays and Onlays
|
13 Inlays/Onlays
|
SECONDARY outcome
Timeframe: Baseline (7-10 days after insertion of restoration)assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations)
Outcome measures
| Measure |
Inlay/Onlay
n=13 Inlays/Onlays
indirect restorative treatment with a glass ceramic: Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.
|
|---|---|
|
Quality Criteria (Modified FDI Criteria)
FDI 1 (Surface Luster), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 1 (Surface Luster), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 2a (Surface Staining), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 2a (Surface Staining), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 2b (Margin Staining), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 2b (Margin Staining), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 (Color Match), FDI Score 1
|
10 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 (Color Match), FDI Score 2
|
3 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 (Color Match), FDI Score 3-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 (Translucency), FDI Score 1
|
12 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 (Translucency), FDI Score 2
|
1 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 (Translucency), FDI Score 3-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 5 (Fractures of material and retention), FDI Score 1
|
8 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 5 (Fractures of material and retention), FDI Score 2
|
5 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 5 (Fractures of material and retention), FDI Score 3-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 6 (Marginal adaptation), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 6 (Marginal adaptation), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 7a (Occlusal contour and wear, qualitatively), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 7a (Occlusal contour and wear, qualitatively), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 10 (Patient's view), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 10 (Patient's view), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 11 (Postoperative (hyper-)sensitivity and tooth vitality), FDI Score 1
|
12 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 11 (Postoperative (hyper-)sensitivity and tooth vitality), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 12 (Recurrence of caries (CAR), erosion, abfraction), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 12 (Recurrence of caries (CAR), erosion, abfraction), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 13 (Tooth integrity (enamel cracks, tooth fractures), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 13 (Tooth integrity (enamel cracks, tooth fractures), FDI Score 2-5
|
0 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 15 (Adjacent mucosa), FDI Score 1
|
13 inlays/onlays
|
|
Quality Criteria (Modified FDI Criteria)
FDI 15 (Adjacent mucosa), FDI Score 2-5
|
0 inlays/onlays
|
Adverse Events
Inlay/Onlay
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place