Alveolar Ridge Abnormality of MaxillaNCT03757195
Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix
A study testing Augmentation in people with Alveolar Ridge Abnormality of Maxilla, run by Cairo University at 2 sites in Egypt.
Trial summary
A new technique of grafting introduce called Mineralized plasmatic matrix. This technique can be used in grafting in anterior zone giving a good results and bone substitution occur using allograft or xenograft. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Abnormality of Maxilla
- What is being tested?
- Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Nov 2018to 25 Oct 2020
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: from 20 to 40 years old
- no history of previous grafting.
- no History of previous implant placement
- Medically Free e.g no debilitating diseases
Who cannot join
- Smoker patients.
- Alcoholic patients
- Pregnant.
- Drug Abusers.
- Hypertensive , Diabetic, having Problems or disease in Kidney and/or liver.
- Thyroid Disease.
Show all 12Show fewer
- Problem in Vit.D absorption or in calcitonin hormone secretion.
- History of blood transfusion or donating blood less than 4 months.
- Patient under Corticosteroid therapy.
- Neurologicaly unstable patients.
- History of radiotherapy or chemo-therapy.
- Patient undergo Spect C.T Scan less than 4 Months .
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Cairo Univerisity
Cairo
Hany M Ahmed, BDS, 00201091971228, hanyyusf4@gmail.com
- Not yet recruiting
Cairo University
Cairo
Tarek I. Abdallah, P.H.D
Hany M. Ahmed, B.D.S
About this study
A new technique of grafting introduce called Mineralized plasmatic matrix. This technique can be used in grafting in anterior zone giving a good results and bone substitution occur using allograft or xenograft.
The bone graft have a good consistency when it mixed with plasma give easy application, strength and stability of the graft. Also plasma rich with CGF (Cellular growth factors).
Read the detailed description
Patients suffering from anterior maxillary vertical and horizontal bone loss will be treated using a xeno-graft mixed with the same patient plasma that extracted from his own blood during the operation this graft will be stabilized by collagen membrane and surgical tags.
Patients will be follow up for 6 months to measure amount of bone loss of the xeno-graft during this period post operative using C.B.C.T
- Conditions
- Alveolar Ridge Abnormality of Maxilla
- Being tested
- Augmentation
- Keywords
- Mineralized plasmatic matrix, sticky bone, plasma, autogeous fibrin glue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AugmentationProcedure or surgery
combination product
| Study group | Role | What they receive |
|---|---|---|
| augmentation by xenograft | Experimental | xenograft mixed with plasma extracted from blood Receives: Procedure: Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of bone loss
amount of bone loss after xenograft by CBCT
Measured: change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start15 Nov 2018
- Primary completion29 Jul 2020 (estimated)
- Study completion25 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge Abnormality of MaxillaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany mostafa ahmed, Cairo University
- Investigators
- Tarek I. Abdallah, P.H.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757195
- Sponsor's protocol ID
- CEBC-CU-2017-11-16
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix
- ClinicalTrials.gov ID
- NCT03757195
- Acronym / sponsor ID
- CEBC-CU-2017-11-16
- Conditions
- Alveolar Ridge Abnormality of Maxilla
- Keywords
- Mineralized plasmatic matrix, sticky bone, plasma, autogeous fibrin glue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 29 Jul 2020 (estimated)
- Study completion
- 25 Oct 2020 (estimated)
- First posted
- 28 Nov 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.
A new technique of grafting introduce called Mineralized plasmatic matrix. This technique can be used in grafting in anterior zone giving a good results and bone substitution occur using allograft or xenograft.
The bone graft have a good consistency when it mixed with plasma give easy application, strength and stability of the graft. Also plasma rich with CGF (Cellular growth factors).
Detailed description
Patients suffering from anterior maxillary vertical and horizontal bone loss will be treated using a xeno-graft mixed with the same patient plasma that extracted from his own blood during the operation this graft will be stabilized by collagen membrane and surgical tags.
Patients will be follow up for 6 months to measure amount of bone loss of the xeno-graft during this period post operative using C.B.C.T
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| augmentation by xenograft | Experimental | Procedure: Augmentationxenograft mixed with plasma extracted from blood |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: from 20 to 40 years old
- no history of previous grafting.
- no History of previous implant placement
- Medically Free e.g no debilitating diseases
Key exclusion criteria (12 listed)
- Smoker patients.
- Alcoholic patients
- Pregnant.
- Drug Abusers.
- Hypertensive , Diabetic, having Problems or disease in Kidney and/or liver.
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 |
|---|---|---|
| Augmentationcombination product | Procedure or surgery | augmentation by xenograft |
Primary outcome
amount of bone loss
Time frame: change from baseline at 6 months
amount of bone loss after xenograft by CBCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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.
Tarek I. Abdallah, P.H.D study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmentation in people with Alveolar Ridge Abnormality of Maxilla, run by Cairo University at 2 sites 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 12 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 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Hany M Ahmed, B.D.S (00201091971228, hanyyusf4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of bone loss (time frame: change from baseline at 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 28 Nov 2018.