Guided Bone Regeneration Using Ti-Reinforced PTFE Membrane Vs. Khoury's Technique in Augmentation of Posterior Mandibular Defects

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atrophic Ridge
• Intervention / Treatment: Procedure: Khoury's bone shell technique; Procedure: GBR using Ti-reinforced PTFE Membrane

Detailed Description

Will using PTFE membrane with a mixture of xenograft and particulate autogenous bone result in bone gain similar to standard Khoury's bone shell technique?

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry - The British University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Khoury's bone shell technique; 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; 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.
Experimental: GBR using Ti-reinforced PTFE Membrane; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cone Beam Volumetric Topography (CBVT)	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical measurement: the frequency of complications	6 Months

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Actual): October 15, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 31, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No