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NCT Number: NCT07324083

Immediate Implant Loading After Ridge Preservation Using Autogenous Dentin Graft and Beta-Tricalcium Phosphate

This randomized controlled clinical trial aimed to evaluate the clinical, radiographic, and histological outcomes of immediate implant loading in extraction sockets preserved using autogenous mineralized dentin graft (AMDG), beta-tricalcium phosphate (β-TCP), or no grafting. Twenty-two patients requiring extraction of maxillary premolars were enrolled, contributing a total of 27 extraction sites. Sites were randomly allocated into three groups: AMDG, β-TCP, or ungrafted control.

Following socket preservation, dental implants were placed after a 6-month healing period and immediately loaded within 48 hours. Alveolar ridge dimensional changes were assessed using cone-beam computed tomography (CBCT) between implant placement and 2 years post-loading. Implant stability, peri-implant soft tissue health, and probing depths were evaluated at loading and during follow-up visits. Histological evaluation of regenerated bone was performed at the time of implant placement.

The study sought to determine whether AMDG provides comparable or superior outcomes to β-TCP and ungrafted sockets in supporting immediate implant loading.

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Key information

Conditions

Tooth Extraction Alveolar Ridge Preservation Immediate Implant Loading

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Egypt

About this study

Immediate implant loading requires adequate primary stability and sufficient bone volume and quality. Ridge preservation techniques are therefore critical in maintaining post-extraction socket dimensions. Autogenous dentin grafts have recently gained attention due to their osteoconductive properties, biocompatibility, and cost-effectiveness.

This study compares AMDG with a commonly used synthetic graft material (β-TCP) and ungrafted sockets to assess their influence on ridge preservation, implant stability, peri-implant tissue health, and bone quality under immediate loading conditions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 years or older
  • Patients requiring extraction of a maxillary premolar tooth
  • Adequate bone height to allow delayed implant placement
  • Good oral hygiene and compliance with follow-up visits
  • Ability to understand the study procedures and provide written informed consent

Exclusion criteria

  • Presence of uncontrolled systemic diseases that could affect bone healing
  • History of radiotherapy to the head and neck region
  • Heavy smoking
  • Active infection or untreated periodontal disease at the extraction site
  • History of bisphosphonate or other antiresorptive drug use
  • Poor oral hygiene or inability to comply with study protocol

Treatment and study plan

Autogenous Mineralized Dentin Graft

Procedure

Extraction sockets were preserved using AMDG prepared from the patient's own extracted tooth. Implants were placed 6 months post-grafting and immediately loaded within 48 hours.

Beta-Tricalcium Phosphate

Procedure

Extraction sockets were preserved using synthetic β-TCP bone graft. Implants were placed 6 months post-grafting and immediately loaded within 48 hours.

Control (Ungrafted Socket)

Procedure

Extraction sockets were left ungrafted and allowed to heal naturally. Implants were placed 6 months post-extraction and immediately loaded within 48 hours.

Primary outcomes

  1. Alveolar Ridge Width Change

    Time frame: From 6 months post-extraction (implant placement) to 2 years post-loading

    Dimensional changes in alveolar ridge width were assessed using CBCT at the center, mesial, and distal sections of each implant site. Measurements were compared between the grafted (AMDG and β-TCP) and control groups over the follow-up period.Unit of Measure: Millimeters (mm)

Secondary outcomes

  1. Implant Stability Quotient (ISQ)

    Time frame: At implant loading, 3 months, and 6 months post-loading

    Implant stability was assessed using resonance frequency analysis to record ISQ values at each follow-up visit for all groups.Unit of Measure: ISQ units(0-100)

  2. Modified Sulcus Bleeding Index (mSBI)

    Time frame: At implant loading, 3 months, and 6 months post-loading

    Peri-implant soft tissue inflammation was evaluated using the mSBI at each follow-up visit for all groups. Unit of Measure: Index score (0-5 scale)

  3. Probing Pocket Depth (PPD)

    Time frame: At implant loading, 3 months, and 6 months post-loading

    Probing depth around each implant was measured using a periodontal probe to assess peri-implant tissue health across all groups.Unit of Measure: Millimeters (mm)

  4. Histological Bone Quality

    Time frame: 6 months post-grafting (at implant placement)

    Histological analysis of bone biopsies obtained from grafted and control sites was performed to evaluate bone maturity, remodeling, and osseointegration. Unit of Measure: Qualitative histological score.

Sponsors and collaborators

Lead sponsor

Soaad Tolba Mohammed Tolba Badawi

Other

Registry information

Official study title

Immediate Implant Loading Following Ridge Preservation: A Randomized Controlled Trial Comparing Autogenous Mineralized Dentin Graft and Beta-Tricalcium Phosphate

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 12, 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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