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

NCT ID: NCT06209905

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-07-01

Brief 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.

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.

Conditions

Alveolar Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Alveolar ridge augmentation

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Alveolar ridge augmentation

Intervention Type: PROCEDURE

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

Interventions

Alveolar ridge augmentation

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: collaborator

Delta University for Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed H Elkenawy, PhD

Role: STUDY_DIRECTOR

Mansoura University

Locations

Mansoura University

Al Mansurah, Addakahlyia, Egypt

Countries

Egypt

Other Identifiers

A06080921

Identifier Type: -

Identifier Source: org_study_id