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

NCT ID: NCT05880771

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Immediate Implant Placement

Intervention Type: 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 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

Group Type: EXPERIMENTAL

Immediate Implant Placement

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saint-Joseph University

OTHER

Sponsor Role: lead

Responsible Party

Christian Makary

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Joseph University

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

XFMD203

Identifier Type: -

Identifier Source: org_study_id