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

Immediate Implant Loading Following Ridge Preservation: A Randomized Controlled Trial Comparing Autogenous Mineralized 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.

Study Overview

• Status: Completed
• Conditions: Tooth Extraction; Alveolar Ridge Preservation; Immediate Implant Loading
• Intervention / Treatment: Procedure: Autogenous Mineralized Dentin Graft; Procedure: Beta-Tricalcium Phosphate; Procedure: Control (Ungrafted Socket)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • Faculty of Dentistry, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autogenous Mineralized Dentin Graft; 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.	Procedure: Autogenous Mineralized Dentin Graft; 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.
Active Comparator: Beta-Tricalcium Phosphate; Extraction sockets were preserved using synthetic β-TCP bone graft. Implants were placed 6 months post-grafting and immediately loaded within 48 hours.	Procedure: Beta-Tricalcium Phosphate; Extraction sockets were preserved using synthetic β-TCP bone graft. Implants were placed 6 months post-grafting and immediately loaded within 48 hours.
Placebo Comparator: Control (Ungrafted Socket); Extraction sockets were left ungrafted and allowed to heal naturally. Implants were placed 6 months post-extraction and immediately loaded within 48 hours.	Procedure: Control (Ungrafted Socket); Extraction sockets were left ungrafted and allowed to heal naturally. Implants were placed 6 months post-extraction and immediately loaded within 48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar Ridge Width Change	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)	From 6 months post-extraction (implant placement) to 2 years post-loading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Stability Quotient (ISQ)	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)	At implant loading, 3 months, and 6 months post-loading
Modified Sulcus Bleeding Index (mSBI)	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)	At implant loading, 3 months, and 6 months post-loading
Probing Pocket Depth (PPD)	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)	At implant loading, 3 months, and 6 months post-loading
Histological Bone Quality	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.	6 months post-grafting (at implant placement)

Collaborators and Investigators

• Sponsor: Soaad Tolba Mohammed Tolba Badawi

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: dental implant; immediate loading; Socket preservation; autogenous dentin graft; beta-tricalcium phosphate
• Additional Relevant MeSH Terms: beta-tricalcium phosphate
• Other Study ID Numbers: R.25.12.95

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No