Bone ResorptionNCT03007069
Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft
A study testing Mineralized plasmatic matrix (MPM). and Autogenous bone graft (gold standard). 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Mineralized plasmatic matrix (MPM). and Autogenous bone graft (gold standard).
- 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 Dec 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients.
- Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
- Patients with Anterior maxillary defective partially edentulous ridge.
- Age between 18 and 40 years.
- Both sexes.
- Patients physically able to tolerate surgical and restorative procedures.
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- Patients with an opposing tooth to the pre-implant site.
- Good oral hygiene.
- Highly motivated patients.
Who cannot join
- Patients allergic to local anesthetic agent.
- Pregnant or lactating females.
- Presence of any pathosis in the pre-implant site.
- Presence of any mucosal disease.
- Presence of parafunctional habits.
- History of oral radiotherapy.
- History of prolonged steroids use.
- Psychological disorders.
About this study
Official title: Implant Insertion in Defective Anterior Maxillary Ridge Augmented Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards.
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 maxillary alveolar ridge requiring implant insertion.
Intervention (I): Ridge augmentation with MPM.
Comparator (C): Autogenous bone graft.
Outcome (O): Patient satisfaction - Implant stability.
- Conditions
- Bone Resorption
- Being tested
- Mineralized plasmatic matrix (MPM)., Autogenous bone graft (gold standard).
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineralized plasmatic matrix (MPM).Other
Also called Sticky bone graft.
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, for 10 minutes , Which will result if sticky bone graft consistency after mixing.
Autogenous bone graft (gold standard).Other
Also called Autobone.
Exposed implant threads are to be covered with autogenous bone and collagen membrane.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous bone graft (Gold Standard). | Experimental | Patients with defective maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and collagen membrane to be used for bone augmentation around exposed threads of inserted dental implants. Receives: Other: Autogenous bone graft (gold standard). |
| MPM Augmentation. | Active comparator | Mineralized plasmatic matrix (MPM) to be used without collagen membrane to augment the defect in the maxillary bone and cover the exposed threads of the dental implants. Receives: Other: Mineralized plasmatic matrix (MPM). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire.
Measured: 5 months
Secondary outcomes (1)
Stability of dental implants , this will be measured using Ostell device in ISQ units.
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 posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionSep 2017 (estimated)
- Study completionDec 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, Mahmoud Usama Mahmoud El Masry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007069
- Sponsor's protocol ID
- CairoMPM-ABG
- Status last verified
- Dec 2016
- First submitted
- 25 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Evaluation of the comparative Effectiveness of MPM Augmentation in Anterior ridge defects with Autogenous bone graft.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Insertion in Defective Anterior Maxillary Ridge Augmented Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
- ClinicalTrials.gov ID
- NCT03007069
- Acronym / sponsor ID
- CairoMPM-ABG
- 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
- Dec 2017 (estimated)
- First posted
- 2 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.
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 maxillary alveolar ridge requiring implant insertion.
Intervention (I): 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 bone graft (gold standard).Patients with defective maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and collagen membrane to be used for bone augmentation around exposed threads of inserted dental implants. |
| MPM Augmentation. | Active comparator | Other: Mineralized plasmatic matrix (MPM).Mineralized plasmatic matrix (MPM) to be used without collagen membrane to augment the defect in the maxillary bone and cover the exposed threads of the dental implants. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Medically free patients.
- Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
- Patients with Anterior maxillary defective partially edentulous ridge.
- Age between 18 and 40 years.
- Both sexes.
Key exclusion criteria (8 listed)
- Patients allergic to local anesthetic agent.
- Pregnant or lactating females.
- Presence of any pathosis in the pre-implant site.
- Presence of any mucosal disease.
- Presence of parafunctional habits.
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 |
|---|---|---|
| Mineralized plasmatic matrix (MPM).Also: Sticky bone graft.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, for 10 minutes , Which will result if sticky bone graft consistency after mixing. | Other | MPM Augmentation. |
| Autogenous bone graft (gold standard).Also: Autobone.Exposed implant threads are to be covered with autogenous bone and collagen membrane. | Other | Autogenous bone graft (Gold Standard). |
Primary outcome
Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire.
Time frame: 5 months
1 secondary outcome
Stability of dental implants , this will be measured using Ostell device in ISQ units.
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 2 Jan 2017.
- Individual participant dataSharing planned: No. Evaluation of the comparative Effectiveness of MPM Augmentation in Anterior ridge defects with Autogenous bone graft.
Related trials for Bone Resorption
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Recruiting
Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement
Dental Implant, Bone Resorption
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Recruiting
The Effect of IPD on Lateral Bone Augmentation
Guided Bone Regeneration, Bone Resorption
Not yet recruitingPhase 1
Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting
Bone Loss, Osteoclastic, Bone Loss, Alveolar
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mineralized plasmatic matrix (MPM). and Autogenous bone graft (gold standard). 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 9 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 2 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire. (time frame: 5 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 2 Jan 2017; AzTrials last refreshed its copy on 30 Oct 2026.