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

NCT06209905 | Completed

• 1 other identifier: A06080921
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Vertical bone height in millimeters

  First postoperative day

• Vertical bone height in millimeters

  Sixth postoperative month

Study Arms (2)

Ti-PTFE

SHAM COMPARATOR

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

Khoury technique

ACTIVE COMPARATOR

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

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.

Khoury technique; Ti-PTFE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Delta University for Science and Technology: lead
• Mansoura University: collaborator

Study Sites (1)

Mansoura University

Al Mansurah, Addakahlyia, 35516, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Alveolar Ridge Augmentation

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Mohamed H Elkenawy, PhD

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 18, 2024
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: July 1, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)