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AzTrials

Alveolar Bone LossNCT03556111

Patient Satisfaction and Bone Gain Following Autogenous Particulate Sticky Bone Preparation With Xenograft Versus Without Xenograft for Grafting of Maxillary Anterior Knife Edge Ridge in Partially Edentulous Patients for Implant Placement

A study testing Sticky bone augmentation in people with Alveolar Bone Loss and Bone Graft; Complications, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim is to evaluate the value and efficiency of sticky bone in the augmentation of alveolar ridge deficiency when being used with or without xenogenic bone graft for esthetic implant placement. Read more about this study

Who is it for?
Ages 18 to 48 yearsHealthy volunteers can take part
Conditions the study is for
Alveolar Bone Loss, Bone Graft; Complications
What is being tested?
Sticky bone augmentation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteEgypt
Study dates
1 Jul 2018to Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 48 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • - Alveolar bone width 3mm or less in anterior maxillary knife edge ridge as evaluated preoperatively on the CBCT
  • Both sexes.
  • Good oral hygiene.
  • Age between 18 and 48 years. Highly motivated patients

Who cannot join

  • - Patient with Bad oral hygiene
  • Post-menopausal females with osteoporosis
  • Patient with uncontrolled systemic disease For instance: uncontrolled Diabetes Mellitus

Trial locations and contacts

1 site in 1 country.

nesma m ibrahim, BDS contact

00201000750518

nesmamattar@outlook.com

mostafa I Shindy, PHD contact

00201121112222

Egypt1 site
  • School of Dentistry , Cairo University.

    Cairo, Giza Governorate

Other trials in Egypt

About this study

Official title: Patient Satisfaction and Bone Gain Following Autogenous Particulate Sticky Bone Preparation With Xenograft Versus Without Xenograft for Grafting of Maxillary Anterior Knife-edge Ridge in Partially Edentulous Patients for Implant Placement

The aim is to evaluate the value and efficiency of sticky bone in the augmentation of alveolar ridge deficiency when being used with or without xenogenic bone graft for esthetic implant placement.

Read the detailed description

Modern Dentistry aims to restore what is missing, no matter what the difficulty is. As many patients have lost their teeth to a number of factors, either trauma or disease or lack of care. Now the individuals are seeking to restore the function and esthetics. The more the number of teeth is missing along with ridge deficiencies can present serious challenges to the clinician.

Implant supported prosthesis is an attractive option for restoring edentulous or partially edentulous patients. However, extensive loss of the alveolar bone is a complex problem that faces many surgeons. This era has witnessed numerous trials and research for bone augmentation for the defective alveolar ridge. The goal is to create sufficient space for endosseous implant placement in a knife edge ridge.

Alveolar bone resorption occurs in either a horizontal or vertical direction. It can also be composite. There are 3 classes of bone-grafting materials based upon the mode of action. Autogenous bone is an organic material and forms bone by osteogenesis, osteoinduction, and osteoconduction.

Allografts such as demineralized freeze-dried bone are osteoinductive and osteoconductive and may be cortical and/or trabecular in nature.

Alloplasts such as hydroxyapatite and tricalcium phosphate may be synthetic or natural, vary in size, and are only osteoconductive. They can be divided into three types based upon the porosity of the product and include dense, macroporous, and microporous materials. In addition, alloplastic materials may be crystalline or amorphous. These materials have different properties and therefore indications.

Previous studies have shown that although the autogenous bone is considered as the Gold Standard of bone grafting for its osteogenic potential, many drawbacks exist which limits its application. For instance, donor site morbidity is of concern. Bone harvesting procedures may put adjacent anatomical structures at a risk of damage. During chin bone harvesting, the mental nerve may be pulled under undue traction and the incisive nerve become interrupted when the harvesting depth is inordinate. Ramus bone harvesting can damage the inferior alveolar nerve. In addition, some patients may be reluctant to the harvesting procedures, especially when extra-oral donor sites are concerned. General anesthesia is mandatory for such operations.

Recent research studies have looked into modifying the surgical techniques in order to regain the space for an implant along with finding satisfying esthetic outcomes. The literature shows the positive use of ridge splitting technique and alveolar distractors, with or without the aid of xenograft material and/or alloplastic material.

Starting from the early 2000s, a new drift of guided bone regeneration research blew by. Platelet concentrates (PC); platelet-rich plasma (PRP) and platelet-rich fibrin (PRF)] were used for surgical procedures in medical and dental fields, particularly in Oral and Maxillofacial surgery, plastic surgery and sports medicine.

They were utilized to accelerate healing of bone graft over the bony defects, many techniques utilizing platelet and fibrinogen concentrations have been introduced in the literature. Platelet is known to contain high quantities of growth factors, such as transforming growth 4 . Factors ß-1 (TGFß-1), platelet-derived growth factor (PDGF), epithelial growth factor (EGF), insulin growth factor-I (IFG-I) and vascular endothelial growth factors (VEGF), which stimulates cell proliferation and upregulates angiogenesis.

Being tested
Sticky bone augmentation
Keywords
implant , sticky bone
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.

  • Sticky bone augmentationProcedure or surgery

    1. Autogenous sticky bone augmentation for the first group
    2. Autogenous sticky bone preparation with xenograft usage
    3. After 5-month of bone grafting; esthetic implant placement
Study groups in NCT03556111
Study groupRoleWhat they receive
anterior knife-edge maxilla graft (Without Xenograft Usage)ExperimentalThe intervention will be a Sticky bone augmentation of defect. It is prepared using particulate autologous graft only along with fibrin glue and growth factors obtained from the patients' blood. The sample is withdrawn and placed in plastic tubes which are spun twice in a centrifuge at a certain speed and time. The first spin to obtain the fibrin glue and the second to obtain the growth factors. The mixture is added to the harvested autogenous bone to form a semi-solid bone graft that is easily manipulated in the recipient site.
Receives: Procedure: Sticky bone augmentation
anterior knife edge maxilla graft (With Xenograft Usage)ExperimentalThe intervention will be the sticky bone augmentation of the defect using both particulate autogenous and xenograft bovine bone. The bone will be harvested from the donor, coupled with the bovine bone, the growth factors and the fibrin glue that is obtained from the patient's own blood sample. The venous blood sample is placed in plastic tubes to be centrifuged at a certain speed and time to obtain the fibrin glue and growth factors. The mixture is prepared until the bone is sticky and ready to be placed in the recipient defective maxilla
Receives: Procedure: Sticky bone augmentation

What is being measured

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

  1. Patient satisfaction

    Patient satisfaction with the bone gain and the prosthetic implant placement

    Measured: 8 months after bone graft placement

Secondary outcomes (2)
  1. bone width gain

    measured in mm

    Measured: 5 month after bone graft placement

  2. Successful implant placement

    it will be measured using OsstellISQ

    Measured: 5 months after bone graft placement

Timeline

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

  1. First posted14 Jun 2018
  2. Study start1 Jul 2018 (estimated)
  3. Primary completionJul 2019 (estimated)
  4. Study completionAug 2019 (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
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556111
Sponsor's protocol ID
Sticky bone augmentation
Status last verified
Jun 2018
First submitted
3 Apr 2018
Last updated
25 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Sticky bone augmentation in people with Alveolar Bone Loss and Bone Graft; Complications, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 2018. 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. 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?

Results are not available in the source record.

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

Contact nesma m ibrahim, BDS (00201000750518, nesmamattar@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction (time frame: 8 months after bone graft placement). 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 25 Jun 2018.

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