Evaluation of Horizontal Bone Gain of Ridge Augmentation Using Customized Porous Zirconia Shell.

NCT07056920 | Recruiting

• 1 other identifier: PER 4.4.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Khoury technique, which employs autogenous bone blocks harvested from the patient, has been widely used for horizontal and vertical ridge augmentation. This method introduces critical limitations, including the technical complexity, morbidity associated with donor site harvesting, such as infection, neurosensory disturbances, and post-operative discomfort This clinical case series aims to demonstrate how customized pours zirconium shell could be an alternative technique for ridge augmentation to overcome the limitations of Khoury shell technique.

Conditions

Horizontal Ridge Deficiency; Deficient Alveolar Bone

Keywords

ridge augmentation; horizontal ridge augmentation; deficient alveolar ridge; zirconia; non resorbable membrane; khoury technique; zirconia membrane; lingual flap advancement

Outcome Measures

Primary Outcomes (1)

• Horizontal bone gain

  Tomographic evaluation of the horizontal bone gain using CBCT in millimeters , CBCT scans will be performed to assess the amount of bone gain in comparison to the preoperative CBCT scans

  6 months postoperatively.

Secondary Outcomes (3)

• Soft tissue dehiscence

  Soft tissue will be evaluated post-operatively at 1, 2, 4, 6, 8, 12, and 16 week recall appointments

• Swelling score

  Swelling score will be evaluated for one week postoperatively

• Pain score

  First thing in the morning for the first 7 days post-operatively.

Study Arms (1)

Zirconia membrane

EXPERIMENTAL

Customized Zirconia membrane will be used as a non resorbable membrane for horizontal ridge augmentation of deficient posterior mandibular region.

Procedure: Zirconia shell technique

Interventions

Zirconia shell technique PROCEDURE

Customized Zirconia membrane will be printed as a porous shell and will be used as a non resorbable membrane for horizontal ridge augmentation of deficient posterior mandibular region.

Zirconia membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years old.
• Deficient lower posterior area (Seibert class I).
• Enough inter-arch space for placement of implant-supported prosthesis.
• Motivated the patient to have the treatment.
• Good oral hygiene.

You may not qualify if:

• Patient with systematic conditions that could interfere with healing process.
• Pregnant females
• Smokers.
• Poor oral hygiene.

Sponsors & Collaborators

• Ahmed Shawky: lead

Study Sites (1)

October University for modern sciences and arts (MSA University)

Giza, Giza Governorate, 12451, Egypt

RECRUITING

Study Officials

• Ahmed R Abd Elrahman, Professor

  Modern Science and Arts University

  STUDY DIRECTOR

• Nada Zazou, Lecturer

  Modern Science and Arts University

  STUDY CHAIR

• Ahmed S Refaey, Bachelor

  Modern Science and Arts University

  PRINCIPAL INVESTIGATOR

• Rasha Attia, Lecturer

  STUDY CHAIR

Central Study Contacts

Ahmed S Refaey, Bachelor

CONTACT

+201111989751; Ahmed.shawky2@msa.edu.eg

Nada Zazou, Lecturer

CONTACT

00201224016945; nzazou@msa.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-06

Locations

EG (1)