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Clinical Trials/NCT05880771
NCT05880771
Completed
Not Applicable

Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year.

Saint-Joseph University1 site in 1 country30 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immediate Implant Placement
Sponsor
Saint-Joseph University
Enrollment
30
Locations
1
Primary Endpoint
Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

This project consists of placing dental implants at extraction sites. Bone drilling and implant placement are performed using the flapless method with the use of a surgical guide allowing guided surgery. After implant placement, temporary teeth are immediately made and placed on the implants to guide the gingival contour.

Bone and soft tissue retraction at the implanted sites are measured radiographically and digitally using surface scan superimposition over a 12-month period.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
November 30, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Saint-Joseph University
Responsible Party
Principal Investigator
Principal Investigator

Christian Makary

Professor

Saint-Joseph University

Eligibility Criteria

Inclusion Criteria

  • Absence of systemic or osseous disease that may impair peri-implant healing
  • Age ≥ 21 years
  • Acceptable oral hygiene
  • Presence of both adjacent teeth
  • Absence of acute infection in the treated area
  • Absence of periodontal pockets \> 3mm at the concerned site
  • Absence of pre-operative defect at the buccal bone wall (dehiscence or fenestration)
  • Per-operative integrity of the osseous and gingival structures (during tooth extraction)
  • Light or non-smoker (\<10 cigarettes per day)

Exclusion Criteria

  • Myocardial infarction within the past 6 months.
  • Poorly controlled diabetes (HBA1c \> 7.5%).
  • Coagulation disorders.
  • Radiotherapy to the head/neck area within the past two years.
  • Present or past treatment with intravenous bisphosphonates.
  • Immunocompromised patients.
  • Psychological or psychiatric problems.
  • Alcohol or drug abuse.
  • Poor oral hygiene and motivation (full mouth plaque score \> 30% and/or full mouth bleeding score \> 20%).
  • Uncontrolled periodontal disease.

Outcomes

Primary Outcomes

Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software

Time Frame: 12 months

Soft Tissue profil retraction after immediate implant placement using 2 different bone substitutes by superimposing STL files between 0 and 12 monts using 3d slicer software

Hard tissue change by superimposing CBCT scans between 0 and 12 months using 3d slicer software

Time Frame: 12 months

Buccal bone profil retraction after immediate implant placement using 2 different bone substitutes by comparing CBCT Dicom files at 0 and 12 months using 3d slicer software

Study Sites (1)

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