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NCT Number: NCT07705399

Evaluation of Autogenous Bone Graft on Immediate Dental Implant Osseointegration Using Piezosurgery

This clinical study aims to evaluate the clinical and radiographic outcomes of immediate dental implant placement in mandibular premolar sites. Patients requiring extraction of mandibular premolars will receive immediate implant placement, with or without autogenous bone grafting, according to the study protocol.

When indicated, autogenous bone graft will be harvested using piezosurgery during the implant procedure. Participants will be followed up clinically and radiographically to assess implant stability, marginal bone level changes, and peri-implant tissue conditions over a defined follow-up period. The results of this study may help determine the effectiveness and predictability of immediate implant placement in mandibular premolar regions.

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This study is active but is not currently recruiting participants.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University, Faculty of Dentistry

Ismailia, 4312, Egypt

About this study

This prospective clinical study is designed to evaluate the clinical and radiographic outcomes of immediate dental implant placement in mandibular premolar regions following tooth extraction. Patients indicated for extraction of mandibular premolars will be enrolled according to predefined inclusion and exclusion criteria.

Following atraumatic tooth extraction, immediate dental implant placement will be performed in the extraction socket. two group included, one without bone graft and the other group with autogenous bone graft from ramus . Autogenous bone grafting will be utilized according to the study protocol and will be harvested intraoperatively using piezosurgery to ensure precise and minimally traumatic bone collection.

Implant placement will be performed following standard surgical protocols. Primary implant stability will be assessed at the time of placement. Patients will receive postoperative care and instructions according to institutional guidelines.

Clinical and radiographic evaluations will be conducted during follow-up visits to assess implant stability, peri-implant soft tissue condition, and marginal bone level changes. Radiographic assessment will be performed using standardized imaging techniques.

The primary outcome measures will include implant stability and marginal bone level changes around the implant. Secondary outcome measures will include implant stability and marginal bone level changes around the implant . overall implant success rate.

The results of this study aim to provide evidence regarding the predictability and effectiveness of immediate implant placement in mandibular premolar sites, with particular emphasis on the role of autogenous bone graft harvested using piezosurgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients requiring extraction of mandibular premolars.
  • Age ≥ 25 years.
  • Adequate oral hygiene and motivated patients for implant treatment.
  • Sufficient bone volume to allow immediate implant placement (with or without minor augmentation).
  • Patients willing to participate and attend follow-up visits for at least 6 months.
  • Systemically healthy patients (ASA I or II).

Exclusion criteria

  • Uncontrolled systemic diseases (e.g., uncontrolled diabetes, immunocompromised patients).
  • Heavy smokers (e.g., >10-15 cigarettes/day).
  • Active periodontal or acute infection at the implant site.
  • Poor oral hygiene or non-compliant patients.
  • Pregnancy or lactation.
  • History of radiotherapy in head and neck region.
  • Severe bone deficiency not suitable for immediate implant placement.

Treatment and study plan

Immediate implant with autogenous bone graft

Procedure

Immediate implant with autogenous bone graft using piezo surgery

Immediate implant without bone graft

Procedure

Immediate implant without bone graft

Primary outcomes

  1. Osseointegration success rate (%)

    Time frame: 6 months after implant placement.

    Implant success will be evaluated based on the absence of mobility, pain, infection, and peri-implant radiolucency around the implant.

Secondary outcomes

  1. Implant stability (ISQ)

    Time frame: At implant placement and 6 months after implant placement

    Implant stability will be measured using resonance frequency analysis (ISQ values) at the time of implant placement and during follow-up.

  2. Marginal bone loss (mm)

    Time frame: Baseline (at implant placement) and 4 months after implant placement

    Marginal bone level changes around the implant will be assessed using standardized periapical radiographs. Measurements will be performed using Digora software

  3. Implant survival rate (%)

    Time frame: 6 months after implant placement

    Presence of implant in situ without mobility or failure at follow-up visit.

  4. Postoperative complication (%)

    Time frame: Up to 6 months after implant placement.

    Clinical assessment of pain, swelling, infection, and delayed healing after implant placement.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Evaluation of Autogenous Bone Graft on Osseointegration of Immediate Dental Implant in Lower Premolars Area Using Piezosurgery

Acronym: ABG-IDIP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

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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