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NCT Number: NCT07669792

Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The British University in Egypt

Cairo, Egypt

Location status: Recruiting

Location contact

Oral and Maxillofacial Lecturer

CONTACT

[email protected]

+201005609359

About this study

The aim of this study is to assess the bone gained histologically when comparing the following different techniques:

One of the techniques that is used for bone augmentation is the Khoury technique which entails that a split cortical bone shell obtained from the ramus area through piezoelectric surgery. The thin laminae of bone obtained is stabilized in the defect area labially through micro screws and the generated gap is filled through a mixture of autogenous that could be obtained from the retromolar area through special burs as the auto chip maker (ACM) or via bone scrapper. The obtained is mixed with an equal ratio with xenograft or bone obtained from animal source to fill the created gap.

Another technique involves the usage of a non-resorbable membrane known as reinforced titanium PTFE that is stabilized from both the lingual and labial aspects via micro screws .It's then filled with a mixture of both autogenous and xenograft for maximizing the bone formation capability. In some cases, the reinforced titanium PTFE is covered with collagen membrane to avoid one of the common drawbacks of this technique which is wound dehiscence.

This study aims to evaluate the bone quality gained from both techniques.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

GBR using Ti based PTFE

Procedure

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.

Bone Shell Khoury's Technique

Procedure

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.

Primary outcomes

  1. Histomorphometric analysis of gained bone

    Time frame: 6 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelaziz H. Saad Abdelkarim, Bachelor's Degree

CONTACT

[email protected]

+201020690459

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis): A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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