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CompletedNCT06209905Updated Jan 18, 2024

Khoury Technique Versus Titanium Reinforced PTFE Membrane in 3D Alveolar Bone Augmentation

An interventional study of Alveolar ridge augmentation in Alveolar Bone Loss, sponsored by Delta University for Science and Technology. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-18.

Sponsored by Delta University for Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Nov 2021, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In patients with missed lower posterior teeth and resorbed lower jaw, the study aimed at restoring the jaw's height and width to accommodate placing dental implants. The study was designed as a clinical trial with two arms; control group and study group. In the control group, titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane was used to secure the grafted bone mixture in the recipient site. While in the study group, bone-plate technique (Khoury technique) for bone restoration was used to secure the grafted bone mixture as well. The donor bone was the lower jaw (for bone particles and bone-plate harvesting) and bovine bone particles mixed together to form the graft mixture. Patients were monitored for six months and assessed by X-rays. The outcome variables were volume and height of gained bone in cubic millimeters and millimeters, respectively.

Read the detailed description

This study targeted bone augmentation in atrophic posterior mandible. Two groups were assigned. The first group included titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane as a rigid modality to achieve guided-bone regeneration (GBR): A mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills, and covered with the mentioned membrane. The second group utilized rigid bone-plates (a bone block was harvested from the mandibular external oblique ridge, then splitted into two plates; one fixated buccally and the other fixated occlusally by bone screws), and the same bone mixture was prepared and introduced as in the first group. All procedures were operated under local anesthesia in a minor oral surgical setting.

Follow-up time intervals were the first postoperative day, and the sixth postoperative month. Two outcome variables were assessed; gained bone volume and gained bone height.

02

Conditions studied

  • Alveolar Bone Loss

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03

In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's enrollment of 16 is below the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Delta University for Science and Technology is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age above 18 years old.
  2. Good oral hygiene.
  3. Missing mandibular posterior teeth.
  4. No history of bruxism or para-functional habits.
  5. Residual alveolar ridge height cannot accommodate dental implant placement.
  6. Patients prepared to comply with the follow-up and maintenance program.
  7. Agreement and signing the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Systemic diseases that may contraindicate the surgery or affect soft tissue or bone healing.
  2. Heavy smoking (more than 20 cigarettes/day).
  3. Intraosseous pathological lesion at the intended grafting site.
  4. Gingival inflammation at the intended implant site.
  5. Periodontal diseases affecting teeth adjacent to the edentulous space.
  6. Inadequate inter-arch space after the indented vertical augmentation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Sham comparator
    Ti-PTFE

    A mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills, and covered with the Ti-PTFE membrane.

    Procedure: Alveolar ridge augmentation

  • Active comparator
    Khoury technique

    A bone block was harvested from the mandibular external oblique ridge, then splitted into two plates; one fixated buccally and the other fixated occlusally by bone screws), and a mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills.

    Procedure: Alveolar ridge augmentation

Interventions

  • ProcedureAlveolar ridge augmentation

    Alveolar ridge augmentation in the three dimensions with either intervention; Ti-PTFE + bone mixture, or Khoury (Bone-plate) technique + bone mixture.

06

What researchers measure

Primary outcomes

  1. Bone volume in cubic millimeters

    Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)

    Time frame: First postoperative day

  2. Bone volume in cubic millimeters

    Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)

    Time frame: Sixth postoperative month

Secondary outcomes

  1. Vertical bone height in millimeters

    Height of the gained bone was assessed by cone-beam computed tomography (CBCT)

    Time frame: First postoperative day

  2. Vertical bone height in millimeters

    Height of the gained bone was assessed by cone-beam computed tomography (CBCT)

    Time frame: Sixth postoperative month

07

Study locations

1 site
  • Mansoura University
    Mansoura, Addakahlyia 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06209905
Lead sponsor
Delta University for Science and Technology
Collaborators
Mansoura University
Responsible party
Sponsor
First posted
Jan 18, 2024
Start date
Nov 1, 2021
Primary completion
Nov 1, 2022
Completion
Jul 1, 2023
Last update
Jan 18, 2024

Study contacts

Mohamed H Elkenawy, PhD
study director · Mansoura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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