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OpenTrials
Completed

NCT Number: NCT07608744

Alloplastic Graft vs Xenograft for Horizontal Alveolar Ridge Augmentation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Dentistry

Izmir, Bornova, 35040, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Alloplastic bone graft

Device

Alloplastic bone graft with collagen membrane, simultaneous implant placement with decompression technique

Xenograft

Device

Xenograft with collagen membrane, simultaneous implant placement with decompression technique

Primary outcomes

  1. Horizontal Alveolar Bone Gain

    Time frame: 6 months

    Change in horizontal alveolar bone width measured by CBCT at baseline and 6 months

Secondary outcomes

  1. Postoperative Edema

    Time frame: 7 days

    Facial edema assessed by measuring three surface distances (lateral orbital rim to mandibular angle, tragus to oral commissure, tragus to pogonion) at baseline, day 2, and day 7

  2. Postoperative Pain

    Time frame: 7 days

    Postoperative pain assessed using the Visual Analogue Scale (VAS); score range 0-10; higher scores indicate worse pain. VAS scores recorded daily for 7 days

  3. Soft Tissue Healing

    Time frame: 7 days

    Wound healing assessed using the Landry wound healing index; score range 1-5; higher scores indicate better healing. Landry wound healing index assessed at postoperative days 2 and 7

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 27, 2026
Registry last updated
Jun 3, 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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