Horizontal Alveolar Bone DefectPhase 2NCT04816110
Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Peri-implant Bone Regeneration
A Phase 2 study testing mineralized plasmatic matrix with collagen membrane and mineralized plasmatic matrix (MPM) without collagen membrane in people with Horizontal Alveolar Bone Defect and Alveolar Bone Loss, run by Alexandria University at 1 site in Egypt.
Trial summary
This study focuses on comparing the effect of MPM with or without collagen membrane on delayed implant placement in anterior maxillary aesthetic zone. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Horizontal Alveolar Bone Defect, Alveolar Bone Loss
- What is being tested?
- mineralized plasmatic matrix with collagen membrane and mineralized plasmatic matrix (MPM) without collagen membrane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2019to 15 Dec 2020
- Phase
- Phase 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with missing anterior maxillary teeth and having deficient alveolar thickness.
- Good oral hygiene
- Alveolar ridge width less than 4 mm.
Who cannot join
- Medically compromised patients.
- Heavy smokers.
- Current chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Periimplant Bone Regeneration (Randomized Clinical Trial)
This study focuses on comparing the effect of MPM with or without collagen membrane on delayed implant placement in anterior maxillary aesthetic zone.
- Being tested
- mineralized plasmatic matrix with collagen membrane, mineralized plasmatic matrix (MPM) without collagen membrane
- 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.
mineralized plasmatic matrix with collagen membraneBiological
Two tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers:
- A yellow plasma liquid on the top of the tube.
- Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM.
After implant placement, the buccal bone defect was grafted with MPM and covered by collagen membrane
mineralized plasmatic matrix (MPM) without collagen membraneBiological
Two tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers:
- A yellow plasma liquid on the top of the tube.
- Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM.
After implant placement, the buccal bone defect was grafted with MPM.
| Study group | Role | What they receive |
|---|---|---|
| mineralized plasmatic matrix with collagen membrane | Experimental | Not described Receives: Biological: mineralized plasmatic matrix with collagen membrane |
| mineralized plasmatic matrix without collagen membrane | Active comparator | Not described Receives: Biological: mineralized plasmatic matrix (MPM) without collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
The visual analog scale was used to gauge the degree of post-operative pain with a scale from zero (lowest) to ten (highest)
Measured: up to 1 week
Postoperative Edema
A visual descriptor analogue scale was utilized to indicate presence/ absence of edema and inflammation with a scale of zero (lowest) to 5 (highest)
Measured: up to 1 week
Peri-implant Probing depth
Probing depth refers to the distance between the gingival margin and the bottom of the pocket. Mesial and distal pockets were measured as close as possible to contact points from the buccal aspect while facial and lingual pockets were measured at the midline of the implant. To prevent excessive tissue damage and over extension into the healthy tissue, the peri-implant sulcus depth was made with light force.
Measured: up to 9 months
Implant stability
The implant stability was measured by Osstell®.The stability was evaluated on buccal, palatal, mesial and distal sides of the implant and the mean values of implant stability quotients ISQs were calculated. SQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start10 Apr 2019
- Primary completion10 Sep 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Alveolar Bone DefectStudies of the same condition, open and under way.
- More trials run by Alexandria 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youmna Aboserie, Alexandria University
- Investigators
- Yomna M Abo Serie, BDS, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptMoustafa El Dibany, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptGaafar N El Halawani, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816110
- Sponsor's protocol ID
- MPM & bone regeneration
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Periimplant Bone Regeneration (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04816110
- Acronym / sponsor ID
- MPM & bone regeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 25 Mar 2021 (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.
This study focuses on comparing the effect of MPM with or without collagen membrane on delayed implant placement in anterior maxillary aesthetic zone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mineralized plasmatic matrix with collagen membrane | Experimental | Biological: mineralized plasmatic matrix with collagen membrane |
| mineralized plasmatic matrix without collagen membrane | Active comparator | Biological: mineralized plasmatic matrix (MPM) without collagen membrane |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with missing anterior maxillary teeth and having deficient alveolar thickness.
- Good oral hygiene
- Alveolar ridge width less than 4 mm.
Key exclusion criteria (3 listed)
- Medically compromised patients.
- Heavy smokers.
- Current chemotherapy or 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 |
|---|---|---|
| mineralized plasmatic matrix with collagen membraneTwo tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers: * A yellow plasma liquid on the top of the tube. * Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM. After implant placement, the buccal bone defect was grafted with MPM and covered by collagen membrane | Biological | mineralized plasmatic matrix with collagen membrane |
| mineralized plasmatic matrix (MPM) without collagen membraneTwo tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers: * A yellow plasma liquid on the top of the tube. * Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM. After implant placement, the buccal bone defect was grafted with MPM. | Biological | mineralized plasmatic matrix without collagen membrane |
Primary outcome
Postoperative Pain
Time frame: up to 1 week
The visual analog scale was used to gauge the degree of post-operative pain with a scale from zero (lowest) to ten (highest)
Postoperative Edema
Time frame: up to 1 week
A visual descriptor analogue scale was utilized to indicate presence/ absence of edema and inflammation with a scale of zero (lowest) to 5 (highest)
Peri-implant Probing depth
Time frame: up to 9 months
Probing depth refers to the distance between the gingival margin and the bottom of the pocket. Mesial and distal pockets were measured as close as possible to contact points from the buccal aspect while facial and lingual pockets were measured at the midline of the implant. To prevent excessive tissue damage and over extension into the healthy tissue, the peri-implant sulcus depth was made with light force.
Implant stability
Time frame: up to 3 months
The implant stability was measured by Osstell®.The stability was evaluated on buccal, palatal, mesial and distal sides of the implant and the mean values of implant stability quotients ISQs were calculated. SQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
Related trials for Horizontal Alveolar Bone Defect
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series
Alveolar Ridge Deficiency, Alveolar Bone Loss
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Guided Bone Regeneration in Lower Posterior Edentulous Arch Using Resorbable or Non Resorbable Membrane.
Horizontal Alveolar Bone Defect, Guided Bone Regeneration
Active, not recruiting
Radiographic and Histomorphometric Assessment of Anterior Horizontal Maxillary Bone Augmentation Using Autogenous and Bovine Sticky Bone Versus Autogenous and Bovine Bone Shell Technique (Khoury): A Randomized Comparative Clinical Trial
Maxillary Augmentation in Horizontal Bone Defect
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Osseodensification Versus Alveolar Ridge Splitting
Maxillary Deficiency, Horizontal Alveolar Bone Defect
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.
Yomna M Abo Serie, BDS principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Moustafa El Dibany, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Gaafar N El Halawani, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mineralized plasmatic matrix with collagen membrane and mineralized plasmatic matrix (MPM) without collagen membrane in people with Horizontal Alveolar Bone Defect and Alveolar Bone Loss, run by Alexandria 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 3 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: finished, as of the sponsor's last update on 25 Mar 2021. 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.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Pain (time frame: up to 1 week). The study lists 4 primary outcomes in all. 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 Mar 2021.