18 and older, any sex, with Alveolar Process Atrophy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pink Esthetic Score (PES) at Temporary Crown Delivery.Primary· value changes between examination carried out 3 and 9 months post-op
Pink Esthetic Score (PES): 0-10; minimum - 0, maximum - 10; the best outcome: 10 PES subscores: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, root convexity/soft tissue color and texture at the facial aspect of the implant site. Minimum 0, maximum - 2; the best outcome: 2
Mesial papilla
Group
Value
95% CI
Group With Implants
1
0 – 1
Distal papilla
Group
Value
95% CI
Group With Implants
1
0 – 1
Curvature of the facial mucosa
Group
Value
95% CI
Group With Implants
1
0.5 – 2
Level of the facial mucosa
Group
Value
95% CI
Group With Implants
1
0.5 – 2
Root convexity/soft tissue color and texture
Group
Value
95% CI
Group With Implants
1
1 – 2
Pink Esthetic Score
Group
Value
95% CI
Group With Implants
5
3 – 8
Papilla Index (PI) at Temporary Crown Delivery.Primary· value changes between examination carried out 3 and 9 months post-op
Papilla Index score: 0-4; the best outcome: 3; minimum: 0, maximum: 4 0 - no papilla present; 1 - less than half of the height of papilla present; 2 - half or more of the height of papilla is present but does not extend all the way up to the contact point between of the crowns; 3 - the papilla fill up the entire proximal space and is in good harmony with the adjacent palillae; 4 - the papilla is hyperplastic and covers too much of the implant restoration and/or the adjacent tooth
Mesial papilla
Group
Value
95% CI
Group With Implants
1
0 – 2
Distal papilla
Group
Value
95% CI
Group With Implants
1
0 – 2
Cone Beam Computed Tomography Examination Taken Right After Implant Installation.Secondary· Assessed immediately after implantation and 12 months post-op
Distance between implant collar and bone margin at buccal and palatal aspect of the crest evaluated on Cone Beam Computed Tomography examination (Pax-i3D Green; Vatech, South Korea).
The change was calculated from two time points as the value at 12 months minus value at baseline.
Group
Value
95% CI
Group With Implants
1.99
± 1.05
Sponsor's own description
Evaluation of the marginal bone and soft tissue alterations after the OsseoSpeed™ EV Profile implants placement in anterior maxilla.
The following parameters will be tested:
* pink esthetic score - at the temporary crown delivery, at the final crown delivery, 6 months post final crown delivery
* papilla index - at the temporary crown delivery, at the final crown delivery, 6 months post final crown delivery
* changes in radiographic marginal bone levels and width at buccal and palatal aspects: differences between baseline (the day of surgery) and 1-year post-op measurements on CBCT will be made.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Medical University of Bialystok
Last refreshed: 2 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04243421.