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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorHams Hamed Abdelrahman

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • customized Zirconia barrier

    Other intervention

    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 intervention

    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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: ZirconiaExperimental treatment 1 intervention
Group B: TitaniumExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

change in vertical height of ridge

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.

Time frame
up to 6 months
2

change in horizontal width of ridge

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.

Time frame
up to 6 months
3

change in volume of ridge

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.

Time frame
up to 6 months

Secondary outcomes

1

symptoms of infection

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

Time frame
up to one month
2

manifestations of wound healing disturbance

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

Time frame
up to one month

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Kafr El-sheikh UniversityRecruiting Kafr ElsheikhEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hams Hamed Abdelrahman

Lead sponsor

Alexandria University

Sponsor institution