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NCT Number: NCT07700095

Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh

Zirconia can be considered as an alternative and innovative material suitable for GBR because it has high biocompatibility, together with a scarce tissue integration. Zirconia barriers could be a predictable and alternative barrier material for GBR in terms of (i) biocompatibility, (ii) ease of use and removal, (iii) exposure management, (iv) bone regeneration outcomes.

Recruiting

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafr El-sheikh University

Kafr Elsheikh, Egypt

Location status: Recruiting

Location contact

Moataz Nasar, BDS

CONTACT

[email protected]

01000353417 ext. 002

Moataz Nasr, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are systemically medically free according to the American Society of Anesthesiologists (ASA) considered as ASA I.
  • Ability to maintain good oral hygiene as evidenced in recall visits.
  • patients who had a partial or completely edentulous alveolar ridge with apparent 3D defect following teeth loss.
  • All patients were free from any local or general disease that may interfere with bone healing and had no history of previous grafting procedure at the designated edentulous ridge.
  • The ridge had to exhibit severe vertical and horizontal (3D) alveolar ridge deficiency with alveolar ridge height less than 7 mm from the alveolar crest to the inferior alveolar canal and width less than 5 mm which was firstly measured by CBCT, or a clinically apparent increase in inter-arch space relative to the adjacent natural teeth.
  • Pre-operative clinical assessment of soft tissue coverage was done to cover the graft and its membrane, in addition to assessment of occlusion and inter-arch distance should allow for the graft, membrane, implan and the future prosthesis.

Exclusion criteria

  • Smoker (> 25 cigarettes/ day).
  • Patients undergoing radiotherapy or chemotherapy
  • Patients having infection or local lesions in the area of surgery.
  • Patients with diabetes mellitus or bone diseases which may compromise the results.
  • Patient with poor oral hygiene or active periodontal disease.
  • Patient with limited mouth opening.
  • Participation in other clinical trials

Treatment and study plan

customized Zirconia barrier

Other

It includes eight patients seeking for placement of customized Zirconia barrier after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.

prebent titanium mesh

Other

It includes eight patients seeking for placement prebent titanium mesh as barriers after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.

Primary outcomes

  1. change in vertical height of ridge

    Time frame: up to 6 months

    Cone Beam Computed Tomography (CBCT) was done immediately (1 week) and after six months to evaluate the changes in vertical, horizontal and volumetric measurements of the ridge. OnDemand3D™ software was used to evaluate vertical and horizontal height. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.

  2. change in horizontal width of ridge

    Time frame: up to 6 months

    Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.

  3. change in volume of ridge

    Time frame: up to 6 months

    Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.

Secondary outcomes

  1. symptoms of infection

    Time frame: up to one month

    Any symptoms of infection including swelling, redness, hotness, pus discharge, and pain will be recorded

  2. manifestations of wound healing disturbance

    Time frame: up to one month

    observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Moataz Nasr

CONTACT

[email protected]

01000353417

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Assessment of Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh: A Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.