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.
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.
mostafa I Shindy, PHD contact
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.
- Conditions
- Alveolar Bone Loss, Bone Graft; Complications
- 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
- Autogenous sticky bone augmentation for the first group
- Autogenous sticky bone preparation with xenograft usage
- After 5-month of bone grafting; esthetic implant placement
| Study group | Role | What they receive |
|---|---|---|
| anterior knife-edge maxilla graft (Without Xenograft Usage) | Experimental | The 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) | Experimental | The 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.
Patient satisfaction
Patient satisfaction with the bone gain and the prosthetic implant placement
Measured: 8 months after bone graft placement
Secondary outcomes (2)
bone width gain
measured in mm
Measured: 5 month after bone graft placement
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.
- First posted14 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mattar, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03556111
- Acronym / sponsor ID
- Sticky bone augmentation
- Conditions
- Alveolar Bone Loss, Bone Graft; Complications
- Keywords
- implant , sticky bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior knife-edge maxilla graft (Without Xenograft Usage) | Experimental | Procedure: Sticky bone augmentationThe 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. |
| anterior knife edge maxilla graft (With Xenograft Usage) | Experimental | Procedure: Sticky bone augmentationThe 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 |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (3 listed)
- - Patient with Bad oral hygiene
- Post-menopausal females with osteoporosis
- Patient with uncontrolled systemic disease For instance: uncontrolled Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sticky bone augmentation1. 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 | Procedure or surgery | anterior knife edge maxilla graft (With Xenograft Usage), anterior knife-edge maxilla graft (Without Xenograft Usage) |
Primary outcome
Patient satisfaction
Time frame: 8 months after bone graft placement
Patient satisfaction with the bone gain and the prosthetic implant placement
2 secondary outcomes
bone width gain
Time frame: 5 month after bone graft placement
Successful implant placement
Time frame: 5 months after bone graft placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: Yes
Related trials for Alveolar Bone Loss
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mostafa I Shindy, PHD contact
1 site in 1 country: see every site and its status.
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.