N/A Completed N=30 Treatment

Marginal Bone and Soft Tissue Alterations After Use of OsseoSpeed EV Profile Implants

Alveolar Process Atrophy

Source: ClinicalTrials.gov NCT04243421 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcomePrimary: Pink Esthetic Score (PES) at Temporary Crown Delivery. — 1; 1; 1; 1 score on a scale — p=0.0007

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pink Esthetic Score (PES) at Temporary Crown Delivery.	1; 1; 1; 1; 1; 5	0.0007 sig
PRIMARY Papilla Index (PI) at Temporary Crown Delivery.	1; 1	0.0005 sig
SECONDARY Cone Beam Computed Tomography Examination Taken Right After Implant Installation.	1.99	0.39

Eligibility Criteria

Inclusion Criteria

lack of tooth in position of central incisors, canines and premolars

Exclusion Criteria

Smoking
Uncontrolled diabetes
Pregnancy or lactation
Poor oral hygiene
Compromised dentition neighboring to edentulous site

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04243421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.