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OpenTrials
Completed

NCT Number: NCT05880771

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.

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Key information

Conditions

Immediate Implant Placement Guided Surgery Immediate Tamporization

Age range

35 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph University

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Hard tissue change by superimposing CBCT scans between 0 and 12 months using 3d slicer software

    Time frame: 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

  2. Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 30, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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