Bone ResorptionMPMNCT03014388
Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
A study testing autogenous bone and Mineralized plasmatic matrix in people with Bone Resorption, run by Cairo University.
Trial summary
Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- autogenous bone and Mineralized plasmatic matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Oct 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients systemically free.
- Patients with posterior maxillary defective ridges indicated for sinus lift procedure.
- Cases with 5 mm bone height or less are included in the study.
- Age between 18 and 50 years.
- Both sexes.
- Patients physically able to tolerate surgical and restorative procedures.
- Good oral hygiene.
- Highly motivated patients.
Who cannot join
- Patients allergic to local anesthetic agent.
- Medium and heavy smokers.
- Pregnant females.
- Presence of any pathosis in the pre-implant site.
- Presence of any mucosal disease.
- History of oral radiotherapy.
- History of prolonged steroids use.
- Psychological disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (A Randomized Clinical Trial Comparative Study)
Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion.
Read the detailed description
To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.
-PICO Population(P) : Patients with defective posterior maxillary alveolar ridge. Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) : Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.
- Conditions
- Bone Resorption
- Being tested
- autogenous bone, Mineralized plasmatic matrix
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autogenous boneOther
Also called Autobone
Autogenous bone graft (gold standard). sinus lift with autogenous bone.
Mineralized plasmatic matrixOther
Also called MPM
By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous bone graft (Gold Standard). | Experimental | Patients with defective posterior maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and to be used for bone augmentation with sinus lift. Receives: Other: autogenous bone |
| Mineralized Plasmatic Matrix (MPM) | Experimental | Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix. Receives: Other: Mineralized plasmatic matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction regarding aesthetic results will be measured using questionnaire.
outcome will be measure using questionnaire.
Measured: 9 months
Secondary outcomes (1)
Stability of dental implants.
will be measured using OSTELL Device.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Refaat Ragab Abu Ellill, Cairo University
- Investigators
- Cairo University CBE, Principal investigator, Cairo University - Ethics Committee.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014388
- Sponsor's protocol ID
- CairoU MPM
- Acronym
- MPM
- Status last verified
- Dec 2016
- First submitted
- 5 Jan 2017
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (A Randomized Clinical Trial Comparative Study)
- ClinicalTrials.gov ID
- NCT03014388
- Acronym / sponsor ID
- MPM / CairoU MPM
- Conditions
- Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- 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.
Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion.
Detailed description
To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.
-PICO Population(P) : Patients with defective posterior maxillary alveolar ridge. Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) : Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenous bone graft (Gold Standard). | Experimental | Other: autogenous bonePatients with defective posterior maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and to be used for bone augmentation with sinus lift. |
| Mineralized Plasmatic Matrix (MPM) | Experimental | Other: Mineralized plasmatic matrixPatients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients systemically free.
- Patients with posterior maxillary defective ridges indicated for sinus lift procedure.
- Cases with 5 mm bone height or less are included in the study.
- Age between 18 and 50 years.
- Both sexes.
Key exclusion criteria (8 listed)
- Patients allergic to local anesthetic agent.
- Medium and heavy smokers.
- Pregnant females.
- Presence of any pathosis in the pre-implant site.
- Presence of any mucosal disease.
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 |
|---|---|---|
| autogenous boneAlso: AutoboneAutogenous bone graft (gold standard). sinus lift with autogenous bone. | Other | Autogenous bone graft (Gold Standard). |
| Mineralized plasmatic matrixAlso: MPMBy using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM. | Other | Mineralized Plasmatic Matrix (MPM) |
Primary outcome
Patient Satisfaction regarding aesthetic results will be measured using questionnaire.
Time frame: 9 months
outcome will be measure using questionnaire.
1 secondary outcome
Stability of dental implants.
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Individual participant dataSharing planned: No. Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.
Related trials for Bone Resorption
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
RecruitingObservational study
A Prospective Natural History Study of Lymphatic Anomalies
Lymphatic Diseases, Lymphatic Abnormalities
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
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.
Cairo University CBE principal investigator
Cairo University - Ethics Committee.
Questions about this trial
What is this clinical trial studying?
A study testing autogenous bone and Mineralized plasmatic matrix in people with Bone Resorption, run by Cairo University.
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 8 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 refaat ragab, Master (01111175536, refaat.ragab.rr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction regarding aesthetic results will be measured using questionnaire. (time frame: 9 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 9 Jan 2017.