Alloplastic Graft vs Xenograft for Horizontal Alveolar Ridge Augmentation

May 20, 2026 updated by: Selin Kenç, Ege University

Clinical and Radiological Evaluation Using Bone Graft Materials in Augmentation of Alveolar Bone Deficiency in Bilateral Posterior Mandible: A Randomized Controlled Study

This prospective split-mouth randomized controlled trial compared horizontal alveolar ridge augmentation using alloplastic bone graft versus xenograft, both performed simultaneously with implant placement using the decompression technique in the posterior mandible. Outcomes included postoperative edema, pain, soft tissue healing, and horizontal bone gain at 6 months assessed by CBCT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bornova
      • Izmir, Bornova, Turkey (Türkiye), 35040
        • Ege University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Bilateral mandibular posterior edentulism with indication for implant-supported rehabilitation
  • Sufficient vertical bone height but insufficient horizontal bone width for implant placement
  • No infection at surgical site
  • Non-smoker
  • No head-and-neck radiotherapy within 2 years
  • No uncontrolled systemic disease (controlled systemic conditions with INR <1.2 acceptable)
  • Signed informed consent

Exclusion Criteria:

  • No indication for implant-supported prosthesis
  • Smoker
  • Active infection at surgical site
  • Head-and-neck radiotherapy within 2 years
  • Uncontrolled systemic disease
  • Allergy to study materials
  • Pregnancy
  • Age under 18
  • Medications interfering with surgical procedures
  • History of mandibular fracture
  • Contraindication to surgery determined by consultation
  • Psychiatric disorder or inability to communication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
Alloplastic bone graft with collagen membrane, simultaneous implant placement with decompression technique
Device: Alloplastic bone graft
Alloplastic bone graft with collagen membrane, simultaneous implant placement with decompression technique
Active Comparator: Control Group
Xenograft and collagen membrane, simultaneous implant placement with decompression technique
Device: Xenograft
Xenograft with collagen membrane, simultaneous implant placement with decompression technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal Alveolar Bone Gain
Time Frame: 6 months
Change in horizontal alveolar bone width measured by CBCT at baseline and 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Edema
Time Frame: 7 days
Facial surface measurements at 3 landmark pairs at baseline, day 2 and day 7
7 days
Postoperative Pain
Time Frame: 7 days
Visual Analogue Scale (VAS) scores recorded daily for 7 days
7 days
Soft Tissue Healing
Time Frame: 7 days
Landry wound healing index assessed at postoperative days 2 and 7
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Collaborators

powerbone

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGE-OMFS-2019-144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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