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Bone Loss, AlveolarNCT06559605

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

A study testing zirconia barrier and titanium mesh in people with Bone Loss, Alveolar, run by Cairo University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Bone Loss, Alveolar
What is being tested?
zirconia barrier and titanium mesh
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteEgypt
Study dates
22 May 2024to 22 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age: 20-70 years.
  • Bone width less than 4mm
  • Vertical bone height less than 9mm
  • Periodontally sound neighboring teeth
  • Patients with sound vertical occlusal bite dimension
  • Good oral hygiene (full mouth plaque control record [PCR] < 25%,full mouth bleeding on probing (BOP) < 25% .
  • Patients demonstrating understanding and commitment to the post-operative care regime and the study follow up timeline.
  • Good general health (including participants with well-controlled systemic disease)

Who cannot join

  • 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
  • Poor oral hygiene after hygienic phase (Plaque control record over 30%) or Active periodontal disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amaal Abdalnassar abdalzeim contact

01003752752

amaalabdalnassar@gmail.com

Omnia Khaled Tawfik contact

omnia.tawfik@dentistry.cu.edu.eg

Egypt1 site, 1 recruiting
  • Cairo university

    Cairo

    Amaal Abdalnassar Abdalzeim, 01003752752, amaalabdalnassar@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical and Radiographic Evaluation of Bone Gain Using Customized 3D Printed Zirconia Barrier Versus Titanium Mesh in Combined Ridge Defects in The Aesthetic Zone: A Randomized Clinical 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.

Read the detailed description

After a tooth is extracted, the alveolar process undergoes an inevitable dimensional change as part of the post extraction remodeling process. The alveolar process is reduced both in the vertical and the horizontal dimension. Therefore, Bone augmentation procedures have been employed to address this issue. A number of bone grafting materials and membranes have been used including resorbable and non-resorbable membranes. It is well-established that non-resorbable membranes produce greater bone augmentation than resorbable ones in terms of their ability to generate new bone. However, their complications make them a less popular option in everyday clinical practice.

Zirconia surfaces show prominent osteo-conductivity, also it has low affinity to bacterial plaque, small amounts of inflammatory infiltrate and good soft-tissue integration. Therefore, this study aims to introduce customized-3D zirconia barriers as a predictable alternative to titanium mesh with horizontal bone gain used as primary outcome.

A randomized clinical trial designed to evaluate the amount of bone gained clinically and radiographically using customized 3D printed zirconia barrier compared to titanium mesh with 26 sites with combined ridge defect total sample size, 13 sites per arm. Once patient preparation is completed and the radiographs are acquired, the patient will be assigned into an arm in the study to allow for barrier manufacturing.

For the zirconia group from the pre-operative CBCT a 3D model of the alveolar jawbone will be created. A 0.4-0.5 mm-thick barrier will then be designed. It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter. The barrier will be milled and sintered, after milling and finishing, the zirconia meshes will be cleaned, dis-infected and sterilized. At the time of the surgery and after administration of anesthesia, the full thickness flap of the atrophic area will be elevated adjacent to the defect site. Autogenous bone particulate will be harvested. Autogenous bone will be harvested by using an auto-chip maker (ACM) bur, autogenous bone chips that collected with ACM bur will be mixed with a xenograft at 50:50 ratio. A try-in of the barrier will be performed before grafting the area to verify whether its adaptation to the recipient site will be correct. A part of the graft will be placed into the atrophic area and the other part of it was placed into the inner side of the barrier. The barrier will be then placed and according to the clinical situation, two or three fixation screws were tightened at 10 N/cm.

The titanium mesh group, an aluminum foil will be adapted to the defect site and used as a guide for trimming the titanium mesh and ensure its adequate fit. The titanium mesh will be polished to prevent dehiscence or premature exposure. It will then stabilize over the particulate graft by 2 mm titanium mini screws at the labial and palatal sides. Releasing incisions of the flaps will be the next step in the procedure. Then, suturing was performed with single and horizontal mattress sutures.

The patient will be instructed to take antibiotics, antiseptic mouth rinse, anti-inflammatory drugs and instructed to apply an ice pack to the treated area for the first 24 hours and to avoid any brushing or trauma to the surgical site for one week.

After 6 months of a healing period a post-operative CBCT will be performed to assess the effectiveness of the GBR procedure, and then Dental implants will be placed according to the bone dimensions. The osteotomy will be initially done using a 4 mm-diameter trephine bur, instead of the pilot drill to acquire a core biopsy. Sequential drilling will then take place until the correct osteotomy size is created for the implant size

Being tested
zirconia barrier, titanium mesh
Keywords
zirconia membrane, titanium membrane, combined bone defect
Medical subject headings
Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zirconia barrierProcedure or surgery

    Also called zirconia membrane

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

  • titanium meshProcedure or surgery

    barrier membrane used for guided bone regeneration

Study groups in NCT06559605
Study groupRoleWhat they receive
zirconia barrierActive comparatorZirconia will be used as a barrier material because it has interesting features and, if compared to titanium, it induces a better fibroblast response. It also shows less biofilm adhesion and less inflammatory response. From the pre-operative CBCT a 3D model of the alveolar jaw bone will be created. A 0.4-0.5 mm-thick barrier will then be designed. It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter.
Receives: Procedure: zirconia barrier
titanium meshPlacebo comparatorTitanium mesh in particular, its clinical suitability for GBR procedures is unmatched by other GBR membranes, due to their exceptional volume stability, titanium meshes are indispensable in the management of vertical or large horizontal bone defects. Titanium meshes not only demonstrate high strength and stiffness but also exhibit good plasticity, allowing them to be perfectly adapted to various bone defects through bending and shaping. Due to titanium mesh's stiffness and sharp edges from cutting and bending, mucosal flaps may be adversely stimulated, leading to mucosal rupture and subsequent mesh exposure
Receives: Procedure: titanium mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. horizontal bone gain

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

    Measured: 6 months

Secondary outcomes (8)
  1. Vertical bone gain

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

    Measured: 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

    Measured: 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

    Measured: up to 4 weeks

  4. Membrane exposure area/percentage

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

    Measured: up to 4 weeks

  5. Soft tissue thickness

    An endodontic spreader with a rubber stopper will be positioned on the soft tissue to record the thickness of the soft tissue.

    Measured: 6 months after barrier placement

  6. Procedural time

    Procedural time will be calculated with a stopwatch to measure the time of each procedure and detect differences in the time spend placing and removing the different membranes.

    Measured: during the surgery

  7. Patient pain

    Readings will be recorded by the patient for the first 12 days after the surgery using the visual analogue scale (VAS) which is a descriptive numerical rating scale of 0 to 10.

    0 = No pain 1-3= Mild pain 4-6 = Moderate pain (bearable) 7-10 = Severe pain (unbearable)

    Measured: first 12 days after the surgery

  8. Patient satisfaction

    Patient will answer questionnaire related to postsurgical and outcome satisfaction (numerical)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start22 May 2024
  3. Primary completion22 May 2026 (estimated)
  4. Study completion22 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06559605
Sponsor's protocol ID
PER 6-3-1.1
Status last verified
Aug 2024
First submitted
12 Jul 2024
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing zirconia barrier and titanium mesh in people with Bone Loss, Alveolar, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amaal Abdalnassar abdalzeim (01003752752, amaalabdalnassar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

horizontal bone gain (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

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