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

NCT07324083 | Completed

• 1 other identifier: R.25.12.95
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Extraction; Alveolar Ridge Preservation; Immediate Implant Loading

Keywords

Socket preservation; immediate loading; autogenous dentin graft; beta-tricalcium phosphate; dental implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Implant Stability Quotient (ISQ)

  At implant loading, 3 months, and 6 months post-loading

• Modified Sulcus Bleeding Index (mSBI)

  At implant loading, 3 months, and 6 months post-loading

• Probing Pocket Depth (PPD)

  At implant loading, 3 months, and 6 months post-loading

• Histological Bone Quality

  6 months post-grafting (at implant placement)

Study Arms (3)

Autogenous Mineralized Dentin Graft

ACTIVE COMPARATOR

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

Beta-Tricalcium Phosphate

ACTIVE COMPARATOR

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

Control (Ungrafted Socket)

PLACEBO COMPARATOR

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)

Interventions

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.

Control (Ungrafted Socket)

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.

Autogenous Mineralized Dentin Graft

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.

Beta-Tricalcium Phosphate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soaad Tolba Mohammed Tolba Badawi: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

beta-tricalcium phosphate

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

EG (1)