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

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.

Study Overview

• Status: Completed
• Conditions: Guided Surgery; Immediate Implant Placement; Immediate Tamporization
• Intervention / Treatment: Other: Immediate Implant Placement

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate implant placement with buccal gap grafted with Allograft; 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	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.
Experimental: Immediate implant placement with buccal gap grafted with Xenograft; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: XFMD203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No