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

Not Applicable

Completed

• Conditions: Guided Surgery; Immediate Tamporization; Immediate Implant Placement
• Interventions: Other: Immediate Implant Placement

• Registration Number: NCT05880771
• Lead Sponsor: Saint-Joseph University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-30
• Status Verified: 2023-07
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate implant placement with buccal gap grafted with Allograft	Immediate Implant Placement	Following tooth extraction immediate implant will be placed in the palatal bone and the buccal gap between the implant and the buccal bone will be grafted with Allograft
Immediate implant placement with buccal gap grafted with Xenograft	Immediate Implant Placement	Following tooth extraction immediate implant will be placed in the palatal bone and the buccal gap between the implant and the buccal bone will be grafted with Xenograft

Primary Outcome Measures

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

Trial Locations

Locations (1)

Saint Joseph University; 🇱🇧 Beirut, Lebanon