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

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

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Alveolar ridge augmentation

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.

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

Contacts and Locations

Study Locations

• Egypt
  • Addakahlyia
    • Mansoura, Addakahlyia, Egypt, 35516
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone volume in cubic millimeters	Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)	First postoperative day
Bone volume in cubic millimeters	Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)	Sixth postoperative month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical bone height in millimeters	Height of the gained bone was assessed by cone-beam computed tomography (CBCT)	First postoperative day
Vertical bone height in millimeters	Height of the gained bone was assessed by cone-beam computed tomography (CBCT)	Sixth postoperative month

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology
• Collaborators: Mansoura University
• Investigators: Study Director: Mohamed H Elkenawy, PhD, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: January 6, 2024
• First Submitted That Met QC Criteria: January 6, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: A06080921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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