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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209905
• Other study ID #: A06080921
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2024
• Source: Delta University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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.

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Addakahlyia

Sponsors (2)

Lead Sponsor	Collaborator
Delta University for Science and Technology	Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone volume in cubic millimeters	Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)	First postoperative day
Primary	Bone volume in cubic millimeters	Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)	Sixth postoperative month
Secondary	Vertical bone height in millimeters	Height of the gained bone was assessed by cone-beam computed tomography (CBCT)	First postoperative day
Secondary	Vertical bone height in millimeters	Height of the gained bone was assessed by cone-beam computed tomography (CBCT)	Sixth postoperative month