Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft

December 30, 2016 updated by: Mahmoud Usama Mahmoud El Masry, Cairo University

Implant Insertion in Defective Anterior Maxillary Ridge Augmented Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft

Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.

-PICO-

Population (P): Patients with defective maxillary alveolar ridge requiring implant insertion.

Intervention (I): Ridge augmentation with MPM.

Comparator (C): Autogenous bone graft.

Outcome (O): Patient satisfaction - Implant stability.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Medically free patients.
  2. Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
  3. Patients with Anterior maxillary defective partially edentulous ridge.
  4. Age between 18 and 40 years.
  5. Both sexes.
  6. Patients physically able to tolerate surgical and restorative procedures.
  7. Patients with an opposing tooth to the pre-implant site.
  8. Good oral hygiene.
  9. Highly motivated patients.

Exclusion Criteria:

  1. Patients allergic to local anesthetic agent.
  2. Pregnant or lactating females.
  3. Presence of any pathosis in the pre-implant site.
  4. Presence of any mucosal disease.
  5. Presence of parafunctional habits.
  6. History of oral radiotherapy.
  7. History of prolonged steroids use.
  8. Psychological disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autogenous bone graft (Gold Standard).
Patients with defective maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and collagen membrane to be used for bone augmentation around exposed threads of inserted dental implants.
Other: Autogenous bone graft (gold standard).
Exposed implant threads are to be covered with autogenous bone and collagen membrane.
Other Names:
  • Autobone.
Active Comparator: MPM Augmentation.
Mineralized plasmatic matrix (MPM) to be used without collagen membrane to augment the defect in the maxillary bone and cover the exposed threads of the dental implants.
Other: Mineralized plasmatic matrix (MPM).
By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM, for 10 minutes , Which will result if sticky bone graft consistency after mixing.
Other Names:
  • Sticky bone graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire.
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Stability of dental implants , this will be measured using Ostell device in ISQ units.
Time Frame: 5 months.
5 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 25, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 30, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoMPM-ABG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Evaluation of the comparative Effectiveness of MPM Augmentation in Anterior ridge defects with Autogenous bone graft.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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