Health TrialsbyHealthPanel

Evaluation of Bone Gain Using Customized 3D Zirconia Barrier Versus Titanium Mesh

ConditionBone Loss, Alveolar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorCairo University

About this trial

Evaluation of clinical and radiographical amount of bone gained using customized 3D printed zirconia barrier compared to titanium mesh in combined ridge defect at the esthetic zone.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 20-70 years.

Bone width less than 4mm

Vertical bone height less than 9mm

Periodontally sound neighboring teeth

Disqualifiers

Pathological lesions (abscess-cyst-acute infection) in the defect site

Systemic diseases that would interfere with bone metabolism

Uncontrolled diabetic patients

Ongoing treatment or a history of recent chemotherapy or radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • zirconia barrier

    Procedure/Surgery

    barrier membrane used for guided bone regeneration and augmentation of ridge defect

  • titanium mesh

    Procedure/Surgery

    barrier membrane used for guided bone regeneration

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: zirconia barrierActive comparator 1 intervention
Group B: titanium meshPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

horizontal bone gain

Horizontal bone gain will be assessed on CBCT after 6 months of bone augmentation

Time frame
6 months

Secondary outcomes

1

Vertical bone gain

measured on CBCT in a linear dimension as a different in measurement between pre and post operative CBCT.

Time frame
6 months after barrier placement
2

Quality of bone

The core biopsies will be sectioned and stained with H\&E stain for examination under a light microscope. Bone volume will be measured for each specimen and the mean volume for native bone and newly formed bone will be calculated for statistics

Time frame
6 months after barrier placement
3

Incidence of membrane exposure

Healing complications including membrane exposure during the period of barrier placement will be recorded and it's evaluated by visual inspection

Time frame
up to 4 weeks
4

Membrane exposure area/percentage

The exposed area will be measured will be assessed by UNC-15 periodontal probe.

Time frame
up to 4 weeks

Other outcomes

Sponsors and contacts

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

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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