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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05880771
Other study ID # XFMD203
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date November 30, 2024

Study information

Verified date June 2023
Source Saint-Joseph University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 74 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Immediate Implant Placement
Tooth extraction followed by immediate implant placement. One group will have Allograft graft in the buccal gap, the other will have Xenograft graft.

Locations

Country Name City State
Lebanon Saint Joseph University Beirut

Sponsors (1)

Lead Sponsor Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hard tissue change by superimposing CBCT scans between 0 and 12 months using 3d slicer software 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 12 months
Primary Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software 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 12 months
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