NCT07608744

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 20, 2026

Last Update Submit

May 31, 2026

Conditions

Alveolar Bone LossEdentulous Jaw

Keywords

atrophic mandiblebone augmentationDecompression techniquealveolar ridge augmentation

Outcome Measures

Primary Outcomes (1)

  • Horizontal Alveolar Bone Gain

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

    6 months

Secondary Outcomes (3)

  • Postoperative Edema

    7 days

  • Postoperative Pain

    7 days

  • Soft Tissue Healing

    7 days

Study Arms (2)

Alloplastic Bone Graft

EXPERIMENTAL

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

Device: Alloplastic bone graft

Xenograft

ACTIVE COMPARATOR

Xenograft and collagen membrane, simultaneous implant placement with decompression technique

Device: Xenograft

Interventions

Alloplastic bone graftDEVICE

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

Alloplastic Bone Graft
XenograftDEVICE

Xenograft with collagen membrane, simultaneous implant placement with decompression technique

Xenograft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Dentistry

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone LossJaw, Edentulous

Interventions

Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesJaw DiseasesMouth, EdentulousTooth Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oral and Maxillofacial Surgeon

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start

October 1, 2019

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)