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Completed

NCT Number: NCT06209905

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Addakahlyia, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Alveolar ridge augmentation

Procedure

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

Primary outcomes

  1. Bone volume in cubic millimeters

    Time frame: First postoperative day

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

  2. Bone volume in cubic millimeters

    Time frame: Sixth postoperative month

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

Secondary outcomes

  1. Vertical bone height in millimeters

    Time frame: First postoperative day

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

  2. Vertical bone height in millimeters

    Time frame: Sixth postoperative month

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

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Collaborators

  • Mansoura University

Registry information

Official study title

Comparison of Khoury Technique Versus Titanium Reinforced PTFE Membrane in 3D Alveolar Bone Augmentation in Atrophic Posterior Mandible

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

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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