Trial Outcomes & Findings for Customized Impressions in Dental Implants - Soft Tissues Changes (NCT NCT03496428)
NCT ID: NCT03496428
Last Updated: 2019-10-30
Results Overview
Discrepancies in soft tissues around implants between different techniques, conventional and digital, in a single unit implant impression, measured as root mean square in µm.
COMPLETED
NA
6 participants
Both techniques will be used in the same appointment upon 3 months use of provisional crown
2019-10-30
Participant Flow
be at least 18 years of age; have at least one implant in the anterior maxilla with the indication for rehabilitation with a definitive implant supported crown; have two mesial and two distal adjacent teeth to the implant and be rehabilitated with a provisional implant supported crown for at least 3 months.
Unit of analysis: tooth and implant sites
Participant milestones
| Measure |
Dental Implant Impression Techniques
Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.
An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined
Dental implant impressions- Different Techniques: Assessment of soft tissues changes with different techniques
|
|---|---|
|
Overall Study
STARTED
|
6 412
|
|
Overall Study
COMPLETED
|
6 412
|
|
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 |
Dental Implant Impression Techniques
n=6 Participants
Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.
An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined
Dental implant impressions- Different Techniques: Assessment of soft tissues changes with different techniques
|
|---|---|
|
Age, Continuous
|
51 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Both techniques will be used in the same appointment upon 3 months use of provisional crownPopulation: Patients with a single implant in the esthetic anterior maxillar zone in need of a definitive crown.
Discrepancies in soft tissues around implants between different techniques, conventional and digital, in a single unit implant impression, measured as root mean square in µm.
Outcome measures
| Measure |
Dental Implant Impression Techniques
n=6 Participants
Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.
An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined
Dental implant impressions- Different Techniques: Assessment of soft tissues changes with different techniques
|
|---|---|
|
Changes in Soft Tissues Around Implant
|
243.89 root mean square in µm
Interval 209.15 to 278.63
|
SECONDARY outcome
Timeframe: Both techniques will be used in the same appointment upon 3 months use of provisional crownPopulation: Patients in need of a definitive crown in a single implant in the esthetic anterior maxillar zone.
Linear measurements in µm between STL files in teeth adjacent to implant in several pre-defined locations
Outcome measures
| Measure |
Dental Implant Impression Techniques
n=6 Participants
Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.
An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined
Dental implant impressions- Different Techniques: Assessment of soft tissues changes with different techniques
|
|---|---|
|
Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant
|
51.08 Root mean square in μm
Interval 45.68 to 56.47
|
Adverse Events
Dental Implant Impression Techniques
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