Immediate Implant Loading Following Ridge Preservation: A Randomized Controlled Trial Comparing Autogenous Mineralized Dentin Graft and Beta-Tricalcium Phosphate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Alveolar Ridge Width Change
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- 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))
Investigators
Soaad Tolba Mohammed Tolba Badawi
Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University
Mansoura University