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

NCT05880771 | Completed

• 1 other identifier: XFMD203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Immediate Implant Placement; Guided Surgery; Immediate Tamporization

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Immediate implant placement with buccal gap grafted with Allograft

EXPERIMENTAL

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

Immediate implant placement with buccal gap grafted with Xenograft

EXPERIMENTAL

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

Interventions

Immediate Implant Placement OTHER

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

Immediate implant placement with buccal gap grafted with Allograft; Immediate implant placement with buccal gap grafted with Xenograft

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 30, 2023
• Study Start: January 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 16, 2025

Record last verified: 2023-07

Locations

LE (1)