NCT07669792

Brief Summary

The purpose of the study is the comparison of bone gained histologically from the Bone Shell Khoury's Technique in comparison with the usage of non-resorbable membrane polytetrafluoroethylene and discussing its eligibility for implant placement in restoring the atrophic posterior mandible.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jun 2025Mar 2027

Study Start

First participant enrolled

June 20, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

June 21, 2026

Last Update Submit

July 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Histomorphometric analysis of gained bone

    Primary evaluation is achieved through re opening of the flap after 6 months for removing the microscrews used in Khoury group and the nonresorbable membrane as well as the screws will be removed from the nonresorbable membrane group. Then the usage of 2 millimeters bur for core biopsy at the site of the implant that will be placed.

    6 Months

Study Arms (2)

GBR using Ti based PTFE

EXPERIMENTAL

This group will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane.

Procedure: GBR using Ti based PTFE

Bone Shell Khoury's Technique

ACTIVE COMPARATOR

This group will receive a block graft using Khoury Technique.

Procedure: Bone Shell Khoury's Technique

Interventions

Patients will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane with full releasing flap buccal and lingual with the lingual dissection for the releasing of the mylohyoid attachment and nerve dissection of the mental nerve buccally. The membrane needs to be fixed lingually with microscrews or titanium screws then the gap will be filled through Auto Chip Maker ACM or bone scraper from the external oblique ridge. Then the harvested bone shall be mixed xenograft with ratio 70 to 30 then the membrane fixed buccally as well as covered by collagen membrane to avoid one of the main obstacles of the procedure which is wound dehiscence.

GBR using Ti based PTFE

A block graft using Khoury Technique: Prior to harvesting the needed bone, measurement of the defect size as well as measurement of the donor site bone block will be harvested from the mandibular retromolar area. The bone shall be acquired through piezoelectric device that perform the osteotomy then separated through the usage of thin chisel. The acquired bone needs to be smoothened to avoid any sharp edge that may cause wound dehiscence or infection. The harvested bone will be divided into two thinner bone shells through using titanium disk with copious irrigation with saline. The bone shell shall be fixated in the defect site buccally through two microscrews at least then the created space shall be filled with a combination of autogenous bones harvested through Auto Chip Maker (ACM) or bone scraper from the external oblique ridge. The harvested bone will be combined with xenograft with ratio 70 to 30 then the defect shall be covered with collagen membrane.

Bone Shell Khoury's Technique

Eligibility Criteria

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

You may qualify if:

  • Have two or more missing teeth in the posterior mandibular segment.
  • The patients age of 18 and above.
  • The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 4mm.
  • Sufficient vertical bone height.
  • Free of any local or systemic condition that may contraindicate ridge expansion procedure.

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.
  • Smokers.
  • Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable.
  • Patients with significant vitamin D deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The British University in Egypt

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Abdelaziz H. Saad Abdelkarim, Bachelor's Degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Candidate

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

June 20, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Locations