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

Immediate Implant Placement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05880771
• Other study ID #: XFMD203
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Guided Surgery
• Immediate Implant Placement

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