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

NCT02998632 | Unknown DMC

• 1 other identifier: CEBC - CU - 2016 - 11 - 165
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Augmentation

Outcome Measures

Primary Outcomes (1)

• Implant body stability in ISQ unit

  Change from baseline implant body stability at 4 months

Secondary Outcomes (1)

• Bone height in Cone beam CT

  Change from baseline bone height at 9 months

Other Outcomes (1)

• Patient satisfaction using questionnare

  9 months

Study Arms (2)

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.

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.

Procedure: Autogenous bone for bone augmentation

Interventions

Mineralized plasmatic matrix for bone augmentation PROCEDURE

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

Also known as: Sticky bone graft

Interventional

Autogenous bone for bone augmentation PROCEDURE

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

Comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 20, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share