ClinicalTrials.gov
ClinicalTrials.gov Menu

Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03007069
Recruitment Status : Not yet recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Mahmoud Usama Mahmoud El Masry, Cairo University

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

Condition or disease Intervention/treatment Phase
Bone Resorption Other: Mineralized plasmatic matrix (MPM). Other: Autogenous bone graft (gold standard). Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implant Insertion in Defective Anterior Maxillary Ridge Augmented Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
Study Start Date : January 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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 Name: 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 Name: Sticky bone graft.




Primary Outcome Measures :
  1. Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire. [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Stability of dental implants , this will be measured using Ostell device in ISQ units. [ Time Frame: 5 months. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Responsible Party: Mahmoud Usama Mahmoud El Masry, Dentist at menistry of health, Cairo University
ClinicalTrials.gov Identifier: NCT03007069     History of Changes
Other Study ID Numbers: CairoMPM-ABG
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Evaluation of the comparative Effectiveness of MPM Augmentation in Anterior ridge defects with Autogenous bone graft.

Additional relevant MeSH terms:
Bone Resorption
Bone Diseases
Musculoskeletal Diseases