Posterior Mandibular Ridge Augmentation Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02998632

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.
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.

Condition or Disease	Intervention/Treatment	Phase
Bone Augmentation	Procedure: Mineralized plasmatic matrix for bone augmentation Procedure: Autogenous bone for bone augmentation	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional 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.	Procedure: Mineralized plasmatic matrix for bone augmentation Vertical bone augmentation of defective posterior mandibular alveolar ridge using MPM (Mineralized Plasmatic Matrix) bone graft. Other Names: Sticky bone graft
Active Comparator: 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.	Procedure: Autogenous bone for bone augmentation Vertical bone augmentation of defective posterior mandibular alveolar ridge using autogenous bone graft (gold standard) covered by titanium membrane.

Arm

Intervention/Treatment

Experimental: Interventional

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.

Procedure: Mineralized plasmatic matrix for bone augmentation

Vertical bone augmentation of defective posterior mandibular alveolar ridge using MPM (Mineralized Plasmatic Matrix) bone graft.

Other Names:

Sticky bone graft

Active Comparator: 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.

Procedure: Autogenous bone for bone augmentation

Vertical bone augmentation of defective posterior mandibular alveolar ridge using autogenous bone graft (gold standard) covered by titanium membrane.

Outcome Measures

Primary Outcome Measures

Implant body stability in ISQ unit [Change from baseline implant body stability at 4 months]

Secondary Outcome Measures

Bone height in Cone beam CT [Change from baseline bone height at 9 months]

Other Outcome Measures

Patient satisfaction using questionnare [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Abdel-Sattar, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT02998632

Other Study ID Numbers:

CEBC - CU - 2016 - 11 - 165

First Posted:

Dec 20, 2016

Last Update Posted:

Dec 20, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Dec 20, 2016