Bone Graft; ComplicationsPhase 1/2NCT03008538
Socket Preservation Using Autogenous Bone Graft Versus MPM
A Phase 1/2 study testing MPM(Mineralized plasmatic matrix). and Autogenous Bone Graft in people with Bone Graft; Complications, run by Cairo University.
Trial summary
Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for implant insertion. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Graft; Complications
- What is being tested?
- MPM(Mineralized plasmatic matrix). and Autogenous Bone Graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2017
- Phase
- Phase 1/2
- 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.
- Patients with mandibular anterior and premolar hopeless teeth indicated for extraction.
- Evaluated bone height on X.Ray to be (0-4 mm buccal bone dehiscence).
- Age between 18 and 40 years.
- Both sexes.
- Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
- Highly motivated patients.
Who cannot join
- Smokers.
- Pregnant or lactating females.
- Presence of any pathosis in the pre-implant site.
- Presence of Para functional habits.
- History of oral radiotherapy.
- History of prolonged steroids use
- Psychological disorders.
About this study
Official title: Dental Implant Placement in Extraction Socket of Mandibular Anterior and Premolar Areas Treated With Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for implant insertion.
Read the detailed description
To assess bone quality, stability of implants placed in fresh extraction sockets of mandibular anterior and premorals augmented by MPM (Mineralized Plasmatic Matrix) versus autogenous bone graft (gold standard), at different follow-up periods (0, 3, 6, 9 months).
- Conditions
- Bone Graft; Complications
- Being tested
- MPM(Mineralized plasmatic matrix)., Autogenous Bone Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPM(Mineralized plasmatic matrix).Other
Also called Sticky bone graft.
Preparation of sticky bone graft by addition of growth factors obtained from patient's vebous blood.
Autogenous Bone GraftOther
Also called Gold Standards
Socket preservation using autogenous bone graft for preservation of bone width and height for future implant insertion.
| Study group | Role | What they receive |
|---|---|---|
| Mineralized Plasmatic Matrix | Experimental | MPM(Mineralized plasmatic matrix) insertion in extraction sockets for socket preservation for later implant placement and histomorphometric analysis. Receives: Other: MPM(Mineralized plasmatic matrix). |
| Autogenous Bone Graft (Gold Standards). | Active comparator | Socket preservation using Autogenous bone graft for later implant placement and histomorphometric analysis. Receives: Other: Autogenous Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction regarding function, to be measured using patient questionnaire.
Measured: 3 Months.
Secondary outcomes (1)
Comparative histomorphometric analysis, to be measured using a digital software called (leica QWin 500) and unit of measurements are to be (Pixels).
Measured: 3 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 startSep 2016
- 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 Graft; ComplicationsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Jamal Taha Hussien, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008538
- Sponsor's protocol ID
- CairoSPR-Aut
- Status last verified
- Dec 2016
- First submitted
- 26 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
- Dental Implant Placement in Extraction Socket of Mandibular Anterior and Premolar Areas Treated With Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
- ClinicalTrials.gov ID
- NCT03008538
- Acronym / sponsor ID
- CairoSPR-Aut
- Conditions
- Bone Graft; Complications
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2016
- 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.
Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for implant insertion.
Detailed description
To assess bone quality, stability of implants placed in fresh extraction sockets of mandibular anterior and premorals augmented by MPM (Mineralized Plasmatic Matrix) versus autogenous bone graft (gold standard), at different follow-up periods (0, 3, 6, 9 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineralized Plasmatic Matrix | Experimental | Other: MPM(Mineralized plasmatic matrix).MPM(Mineralized plasmatic matrix) insertion in extraction sockets for socket preservation for later implant placement and histomorphometric analysis. |
| Autogenous Bone Graft (Gold Standards). | Active comparator | Other: Autogenous Bone GraftSocket preservation using Autogenous bone graft for later implant placement and histomorphometric analysis. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Medically free patients.
- Patients with mandibular anterior and premolar hopeless teeth indicated for extraction.
- Evaluated bone height on X.Ray to be (0-4 mm buccal bone dehiscence).
- Age between 18 and 40 years.
- Both sexes.
Key exclusion criteria (7 listed)
- Smokers.
- Pregnant or lactating females.
- Presence of any pathosis in the pre-implant site.
- Presence of Para functional habits.
- History of oral radiotherapy.
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 |
|---|---|---|
| MPM(Mineralized plasmatic matrix).Also: Sticky bone graft.Preparation of sticky bone graft by addition of growth factors obtained from patient's vebous blood. | Other | Mineralized Plasmatic Matrix |
| Autogenous Bone GraftAlso: Gold StandardsSocket preservation using autogenous bone graft for preservation of bone width and height for future implant insertion. | Other | Autogenous Bone Graft (Gold Standards). |
Primary outcome
Patient Satisfaction regarding function, to be measured using patient questionnaire.
Time frame: 3 Months.
1 secondary outcome
Comparative histomorphometric analysis, to be measured using a digital software called (leica QWin 500) and unit of measurements are to be (Pixels).
Time frame: 3 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: Undecided
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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 Phase 1/2 study testing MPM(Mineralized plasmatic matrix). and Autogenous Bone Graft in people with Bone Graft; Complications, 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 7 inclusion and 7 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 function, to be measured using patient questionnaire. (time frame: 3 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.