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N/A N=30 Treatment

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

Alveolar Process Atrophy

Bottom Line

View on ClinicalTrials.gov: NCT04243421 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Pink Esthetic Score (PES) at Temporary Crown Delivery. — 1; 1; 1; 1 score on a scale — p=0.0007

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Implantation (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Medical University of Bialystok
Primary completion
Aug 2019

Outcome Measures

OutcomeResultp-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

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.

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.

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