NCT07394933

Brief Summary

The aim of the present clinical trial is to compare two different alveolar ridge bone augmentation techniques for mandibular horizontal bone defects.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

June 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 31, 2026

Last Update Submit

February 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cone Beam Volumetric Topography (CBVT)

    6 Months

Secondary Outcomes (1)

  • Clinical measurement: the frequency of complications

    6 Months

Study Arms (2)

Khoury's bone shell technique

ACTIVE COMPARATOR

Bone blocks will be harvested from the retromolar area after measuring of the size required and measuring of the donor site anatomy. Piezoelectric device will be used to perform the graft osteotomy. The block size should be slightly larger than the defect size. Sharp bony edges will be smoothened, and the donor defect will be packed with gelatin sponges. The bone block margins will be smoothened and separated into two thinner bone shells using titanium disk with copious saline irrigation. The blocks will be fixed into the recipient site buccally using at least two micro-screws leaving a gap to be filled with bone graft.

Procedure: Khoury's bone shell technique

GBR using Ti-reinforced PTFE Membrane

EXPERIMENTAL

A non-resorbable ti-enforced polytetrafluoroethylene (PTFE) membrane will be fixed with titanium screws on the lingual bone plate and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft).

Procedure: GBR using Ti-reinforced PTFE Membrane

Interventions

Bone blocks will be harvested from the retromolar area after measuring of the size required and measuring of the donor site anatomy. Piezoelectric device will be used to perform the graft osteotomy. The block size should be slightly larger than the defect size. Sharp bony edges will be smoothened, and the donor defect will be packed with gelatin sponges. The bone block margins will be smoothened and separated into two thinner bone shells using titanium disk with copious saline irrigation. The blocks will be fixed into the recipient site buccally using at least two micro-screws leaving a gap to be filled with bone graft.

Khoury's bone shell technique

A non-resorbable ti-enforced polytetrafluoroethylene (PTFE) membrane will be fixed with titanium screws on the lingual bone plate and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft).

GBR using Ti-reinforced PTFE Membrane

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have one or more missing teeth in the posterior mandibular segment.
  • The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 5 mm.
  • Sufficient vertical bone height above inferior alveolar nerve.
  • Free of any local or systemic condition that may contraindicate ridge expansion procedure.
  • No sex predilection.
  • The patient will be between the ages of 18-70 years.

You may not qualify if:

  • Patients taking any medication that may interfere with bone healing or bone biology.
  • Patients with any systemic disease that may affect bone healing.
  • Any patients with any previous bone grafting procedure at the site of interest.
  • Heavy Smokers (more than 20 cigarettes daily).
  • Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - The British University in Egypt

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 6, 2026

Study Start

June 15, 2025

Primary Completion

October 15, 2025

Study Completion

April 1, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations