NCT07869485

Brief Summary

This study will compare three different ratios of autogenous bone and xenograft used for horizontal alveolar ridge augmentation in patients with insufficient bone width for dental implant placement. Participants will be randomly assigned to receive one of three bone graft mixtures: 50% autogenous bone and 50% xenograft, 75% autogenous bone and 25% xenograft, or 25% autogenous bone and 75% xenograft. The aim of the study is to determine whether the different bone graft ratios result in different amounts of horizontal bone gain. Bone changes will be assessed clinically and using cone-beam computed tomography (CBCT) during follow-up.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Oct 2026

Status
not yet recruiting

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 Progress3%
Oct 2026Sep 2027

Study Start

First participant enrolled

October 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

11 months

First QC Date

October 6, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

Guided Bone Regeneration Horizontal Ridge Augmentation Alveolar Ridge Augmentation Autogenous Bone Xenograft Bone Graft Sausage Technique

Outcome Measures

Primary Outcomes (1)

  • Radiographic Horizontal Bone Gain

    The change in horizontal alveolar ridge width from baseline to 6 months after horizontal ridge augmentation, measured radiographically using cone-beam computed tomography (CBCT).

    Baseline to 6 months after augmentation

Secondary Outcomes (10)

  • Clinical Horizontal Bone Gain

    6 months after augmentation

  • Vertical Bone Gain

    Baseline to 6 months after augmentation

  • Histomorphometric Bone Quality

    6 months after augmentation

  • Soft Tissue Thickness

    Baseline and 3 and 6 months after augmentation

  • Keratinized Tissue Width

    Baseline and 3 and 6 months after augmentation

  • +5 more secondary outcomes

Study Arms (3)

50:50 Autogenous Bone-Xenograft

EXPERIMENTAL

Participants will receive horizontal alveolar ridge augmentation using a 50:50 mixture of autogenous bone and xenograft, covered with a collagen membrane using the sausage technique.

Procedure: 50:50 Autogenous Bone-Xenograft

75:25 Autogenous Bone-Xenograft

EXPERIMENTAL

Participants will receive horizontal alveolar ridge augmentation using a 75:25 mixture of autogenous bone and xenograft, covered with a collagen membrane using the sausage technique.

Procedure: 75:25 Autogenous Bone-Xenograft

25:75 Autogenous Bone-Xenograft

EXPERIMENTAL

Participants will receive horizontal alveolar ridge augmentation using a 25:75 mixture of autogenous bone and xenograft, covered with a collagen membrane using the sausage technique.

Procedure: 25:75 Autogenous Bone-Xenograft

Interventions

Horizontal alveolar ridge augmentation using a 50:50 mixture of autogenous bone and xenograft with a collagen membrane using the sausage technique.

50:50 Autogenous Bone-Xenograft

Horizontal alveolar ridge augmentation using a 75:25 mixture of autogenous bone and xenograft with a collagen membrane using the sausage technique.

75:25 Autogenous Bone-Xenograft

Horizontal alveolar ridge augmentation using a 25:75 mixture of autogenous bone and xenograft with a collagen membrane using the sausage technique.

25:75 Autogenous Bone-Xenograft

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 20 to 70 years.
  • Patients with multiple missing mandibular posterior teeth (2 or more).
  • Patients with compromised bone width in the posterior mandible (≤4 mm) and adequate bone height (not less than 9 mm).
  • Patients with healthy systemic condition.
  • Adequate inter-arch space for placement of the implant prosthetic part (8-12 mm).
  • Good oral hygiene.
  • Cooperative patients who are willing to commit to 6 months of follow-up.

You may not qualify if:

  • Smokers.
  • Pathological lesions (abscess, cyst, or acute infection) at the defect site.
  • Pregnant females.
  • Uncontrolled diabetic patients.
  • Patients taking medications or receiving treatments that may interfere with healing, including corticosteroids, bisphosphonates, chemotherapy, or radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • eslam hisham mohamed, B.Sc.

    Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

eslam hisham mohamed, B.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to the treatment group allocation during outcome assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's student

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 9, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers because no specific plan for IPD sharing has been established, and participant-level data will be retained by the research team for study and academic purposes.