Bone AugmentationNCT02998632
Posterior Mandibular Ridge Augmentation Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
A study testing Mineralized plasmatic matrix for bone augmentation and Autogenous bone for bone augmentation in people with Bone Augmentation, run by Cairo University.
Trial summary
Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will start their surgical treatment in the next visit after radiographic and surgical site evaluation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Augmentation
- What is being tested?
- Mineralized plasmatic matrix for bone augmentation and Autogenous bone for bone augmentation
- Type of treatment
- Surgery or procedure
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients.
- Patients with posterior mandibular defective partially edentulous ridge.
- Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
- Patients physically able to tolerate surgical and restorative procedures.
- Patients with an opposing tooth to the pre-implant site.
- Good oral hygiene.
- Highly motivated patients.
Who cannot join
- Patients allergic to local anaesthetic agent.
- smokers.
- Pregnant or lactating females.
- Presence of any pathosis in the pre-implant site.
- Presence of parafunctional habits.
- History of oral radiotherapy.
- History of prolonged steroids use.
- Psychological disorders.
About this study
Official title: The Effect of Posterior Mandibular Ridge Augmentation Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft on Implant Body Stability: A Randomized Clinical Trial Comparative Study
- Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will start their surgical treatment in the next visit after radiographic and surgical site evaluation.
- On the day of surgery, each patient will be assigned to either intervention or control group, the patients will receive inferior alveolar nerve block and long buccal nerve anesthesia. Future implant site will be planned, an incision will be made and flap will be reflected along the defective ridge.
- Implant fixture/s will be inserted in the previously planned site. Uncovered fixture threads and bone defect will be covered by MPM or autogenous bone graft.
- In the control group, autogenous particulate bone graft will be used for vertical augmentation and covered with titanium reinforced membrane. In the intervention group, MPM (Mineralized plasmatic matrix) will be used.
- Edges will be approximated, Sutures will be placed.
- Osstell instrument will be used to measure and record fixture primary stability in ISQ units.
- Patients will be referred to the fixed prosthodontics department for placement of the crowns after ensuring success of osseointegration and implant stability (after 4 months).
- Patients will evaluate their overall satisfaction after fitting the final prosthesis using a questionnaire at 9 months.
- After 9 months, CBCT will be performed to evaluate augmented bone height to be compared with the bone height previously recorded in CBCT.
- Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to be compared to the ratio recorded before.
Read the detailed description
In the study group:
- Full medical and dental history will be obtained from all the patients participating in this study (figure 2).
- Thorough clinical and radiographic examination for the ridge area to be treated will be done.
- Future implant site will be planned.
- Each patient will be asked to evaluate their overall satisfaction using a questionnaire before any intervention.
- Patients will receive 2 gm of amoxicillin 1 hour before surgery. They will be instructed to wash their mouths with a 0.12% chlorhexidine solution for 30 seconds immediately before surgery.
- The patient will receive inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution using aspirating syringe and 27-gauge needle.
- After confirming the success of profound local anaesthesia, an incision will be made and flap will be reflected along the ridge of the previously planned intraoral donor site to completely expose bone.
- Autogenous bone graft will be obtained and will be grinded according to the dimensions of the present defect.
- MPM (Mineralized plasmatic matrix) will be prepared:
Tubes of 9 ml of venous blood will be taken from the patient and will be placed in a centrifuge at 2500 rpm / min for 5 min.
At the end of the centrifugation, the blood in the tube will be separated into two compartments one yellow and one red.
The yellow part will be withdrawn with a syringe to be mixed with the grinded autogenous bone previously obtained from intra oral site.
Components will be mixed using a probe until the formation of a single homogeneous component, called the MPM (Mineralized Plasmatic Matrix).
- The graft site receiver will be prepared by perforating the lateral cortical bone to improve the vascularization and facilitate cell migration.
- Implant fixture/s will be inserted in the previously planned site.
- Uncovered fixture threads and bone defect will be covered by MPM.
- Osstell instrument will be used to measure and record fixture primary stability in ISQ units precisely and objectively 48.
- Edges will be approximated, Sutures will be placed.
- Sutures will be removed 7 days later.
- Immediate postoperative CBCT will be performed.
- Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed after the surgical procedure to be administrated by the patients.
- Patients will be referred to the fixed prosthodontics department for placement of the crowns after ensuring success of osseointegration and implant stability (after 4 months).
In the control group:
- The Same previously mentioned procedure will be performed, But here gold standards are to be performed (Autogenous particulate bone graft used for vertical augmentation will be covered with titanium reinforced membrane).
- Osstell tool will be used to measure and record fixture primary stability in ISQ units.
- Suturing will be performed.
- Then Immediate Post operative CBCT will be performed.
- Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed after the surgical procedure to be administrated by the patients.
- Patients will be referred to the fixed prosthodontics department for placement of the crowns after ensuring success of osseointegration and implant stability (after 4 months).
Postoperative follow up in both groups:
- After 4 months, Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to be compared to the ratio recorded before.
- After 9 months, Patients will evaluate their overall satisfaction after fitting the final prosthesis using a questionnaire to be answered by YES or NO.
- -After 9 months, CBCT will be performed to evaluate augmented bone height to be compared with the bone height previously recorded in CBCT.
- Conditions
- Bone Augmentation
- Being tested
- Mineralized plasmatic matrix for bone augmentation, Autogenous bone for bone augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineralized plasmatic matrix for bone augmentationProcedure or surgery
Also called Sticky bone graft
Vertical bone augmentation of defective posterior mandibular alveolar ridge using MPM (Mineralized Plasmatic Matrix) bone graft.
Autogenous bone for bone augmentationProcedure or surgery
Vertical bone augmentation of defective posterior mandibular alveolar ridge using autogenous bone graft (gold standard) covered by titanium membrane.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Patients will receive 2 gm of amoxicillin 1 hour before surgery. Mouthwash 0.12% chlorhexidine solution for 30 seconds immediately before surgery.
Inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution.
Flap will be reflected in intraoral donor site to completely expose bone. Autogenous bone graft will be obtained and will be ground. MPM (Mineralized plasmatic matrix) will be prepared. Implant fixture/s will be inserted. Uncovered fixture threads and bone defect will be covered by MPM. Osstell will be used to measure fixture primary stability in ISQ units. Sutures will be placed. Sutures will be removed 7 days later. Immediate postoperative CBCT will be performed. Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed. Receives: Procedure: Mineralized plasmatic matrix for bone augmentation |
| Comparator | Active comparator | Patients will receive 2 gm of amoxicillin 1 hour before surgery. Mouthwash 0.12% chlorhexidine solution for 30 seconds immediately before surgery.
The patient will receive inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution Flap will be reflected in intraoral donor site to completely expose bone. Autogenous bone graft will be obtained and will be ground. Implant fixture/s will be inserted. Uncovered fixture threads and bone defect will be covered by autogenous bone graft and covered by titanium membrane.
Osstell instrument will be used to measure and record fixture primary stability in ISQ units.
Sutures will be placed. Sutures will be removed 7 days later. Immediate postoperative CBCT will be performed. Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed. Receives: Procedure: Autogenous bone for bone augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant body stability in ISQ unit
Measured: Change from baseline implant body stability at 4 months
Secondary outcomes (1)
Bone height in Cone beam CT
Measured: Change from baseline bone height at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 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 AugmentationStudies 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, Ahmed Abdel-Sattar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998632
- Sponsor's protocol ID
- CEBC - CU - 2016 - 11 - 165
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Posterior Mandibular Ridge Augmentation Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft on Implant Body Stability: A Randomized Clinical Trial Comparative Study
- ClinicalTrials.gov ID
- NCT02998632
- Acronym / sponsor ID
- CEBC - CU - 2016 - 11 - 165
- Conditions
- Bone Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Dec 2016 (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.
- Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will start their surgical treatment in the next visit after radiographic and surgical site evaluation.
- On the day of surgery, each patient will be assigned to either intervention or control group, the patients will receive inferior alveolar nerve block and long buccal nerve anesthesia. Future implant site will be planned, an incision will be made and flap will be reflected along the defective ridge.
- Implant fixture/s will be inserted in the previously planned site. Uncovered fixture threads and bone defect will be covered by MPM or autogenous bone graft.
- In the control group, autogenous particulate bone graft will be used for vertical augmentation and covered with titanium reinforced membrane. In the intervention group, MPM (Mineralized plasmatic matrix) will be used.
- Edges will be approximated, Sutures will be placed.
- Osstell instrument will be used to measure and record fixture primary stability in ISQ units.
- Patients will be referred to the fixed prosthodontics department for placement of the crowns after ensuring success of osseointegration and implant stability (after 4 months).
- Patients will evaluate their overall satisfaction after fitting the final prosthesis using a questionnaire at 9 months.
- After 9 months, CBCT will be performed to evaluate augmented bone height to be compared with the bone height previously recorded in CBCT.
- Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to be compared to the ratio recorded before.
Detailed description
In the study group:
- Full medical and dental history will be obtained from all the patients participating in this study (figure 2).
- Thorough clinical and radiographic examination for the ridge area to be treated will be done.
- Future implant site will be planned.
- Each patient will be asked to evaluate their overall satisfaction using a questionnaire before any intervention.
- Patients will receive 2 gm of amoxicillin 1 hour before surgery. They will be instructed to wash their mouths with a 0.12% chlorhexidine solution for 30 seconds immediately before surgery.
- The patient will receive inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution using aspirating syringe and 27-gauge needle.
- After confirming the success of profound local anaesthesia, an incision will be made and flap will be reflected along the ridge of the previously planned intraoral donor site to completely expose bone.
- Autogenous bone graft will be obtained and will be grinded according to the dimensions of the present defect.
- MPM (Mineralized plasmatic matrix) will be prepared:
Tubes of 9 ml of venous blood will be taken from the patient and will be placed in a centrifuge at 2500 rpm / min for 5 min.
At the end of the centrifugation, the blood in the tube will be separated into two compartments one yellow and one red.
The yellow part will be withdrawn with a syringe to be mixed with the grinded autogenous bone previously obtained from intra oral site.
Components will be mixed using a probe until the formation of a single homogeneous component, called the MPM (Mineralized Plasmatic Matrix).
- The graft site receiver will be prepared by perforating the lateral cortical bone to improve the vascularization and facilitate cell migration.
- Implant fixture/s will be inserted in the previously planned site.
- Uncovered fixture threads and bone defect will be covered by MPM.
- Osstell instrument will be used to measure and record fixture primary stability in ISQ units precisely and objectively 48.
- Edges will be approximated, Sutures will be placed.
- Sutures will be removed 7 days later.
- Immediate postoperative CBCT will be performed.
- Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed after the surgical procedure to be administrated by the patients.
- Patients will be referred to the fixed prosthodontics department for placement of the crowns after ensuring success of osseointegration and implant stability (after 4 months).
In the control group:
- The Same previously mentioned procedure will be performed, But here gold standards are to be performed (Autogenous particulate bone graft used for vertical augmentation will be covered with titanium reinforced membrane).
- Osstell tool will be used to measure and record fixture primary stability in ISQ units.
- Suturing will be performed.
- Then Immediate Post operative CBCT will be performed.
- Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed after the surgical procedure to be administrated by the patients.
- Patients will be referred to the fixed prosthodontics department for placement of the crowns after ensuring success of osseointegration and implant stability (after 4 months).
Postoperative follow up in both groups:
- After 4 months, Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to be compared to the ratio recorded before.
- After 9 months, Patients will evaluate their overall satisfaction after fitting the final prosthesis using a questionnaire to be answered by YES or NO.
- -After 9 months, CBCT will be performed to evaluate augmented bone height to be compared with the bone height previously recorded in CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: Mineralized plasmatic matrix for bone augmentationPatients will receive 2 gm of amoxicillin 1 hour before surgery. Mouthwash 0.12% chlorhexidine solution for 30 seconds immediately before surgery. Inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution. Flap will be reflected in intraoral donor site to completely expose bone. Autogenous bone graft will be obtained and will be ground. MPM (Mineralized plasmatic matrix) will be prepared. Implant fixture/s will be inserted. Uncovered fixture threads and bone defect will be covered by MPM. Osstell will be used to measure fixture primary stability in ISQ units. Sutures will be placed. Sutures will be removed 7 days later. Immediate postoperative CBCT will be performed. Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed. |
| Comparator | Active comparator | Procedure: Autogenous bone for bone augmentationPatients will receive 2 gm of amoxicillin 1 hour before surgery. Mouthwash 0.12% chlorhexidine solution for 30 seconds immediately before surgery. The patient will receive inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution Flap will be reflected in intraoral donor site to completely expose bone. Autogenous bone graft will be obtained and will be ground. Implant fixture/s will be inserted. Uncovered fixture threads and bone defect will be covered by autogenous bone graft and covered by titanium membrane. Osstell instrument will be used to measure and record fixture primary stability in ISQ units. Sutures will be placed. Sutures will be removed 7 days later. Immediate postoperative CBCT will be performed. Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Medically free patients.
- Patients with posterior mandibular defective partially edentulous ridge.
- Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
- Patients physically able to tolerate surgical and restorative procedures.
- Patients with an opposing tooth to the pre-implant site.
Key exclusion criteria (8 listed)
- Patients allergic to local anaesthetic agent.
- smokers.
- Pregnant or lactating females.
- Presence of any pathosis in the pre-implant site.
- 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 for bone augmentationAlso: Sticky bone graftVertical bone augmentation of defective posterior mandibular alveolar ridge using MPM (Mineralized Plasmatic Matrix) bone graft. | Procedure or surgery | Interventional |
| Autogenous bone for bone augmentationVertical bone augmentation of defective posterior mandibular alveolar ridge using autogenous bone graft (gold standard) covered by titanium membrane. | Procedure or surgery | Comparator |
Primary outcome
Implant body stability in ISQ unit
Time frame: Change from baseline implant body stability at 4 months
1 secondary outcome
Bone height in Cone beam CT
Time frame: Change from baseline bone height at 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: No
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
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Not yet recruitingObservational study
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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 study testing Mineralized plasmatic matrix for bone augmentation and Autogenous bone for bone augmentation in people with Bone Augmentation, 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 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 20 Dec 2016. 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?
Implant body stability in ISQ unit (time frame: Change from baseline implant body stability at 4 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 20 Dec 2016.