Socket Preservation Using Autogenous Bone Graft Versus MPM

December 30, 2016 updated by: Khaled Jamal Taha Hussien, Cairo University

Dental Implant Placement in Extraction Socket of Mandibular Anterior and Premolar Areas Treated With Mineralized Plasmatic Matrix Versus Autogenous Bone Graft

Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for implant insertion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To assess bone quality, stability of implants placed in fresh extraction sockets of mandibular anterior and premorals augmented by MPM (Mineralized Plasmatic Matrix) versus autogenous bone graft (gold standard), at different follow-up periods (0, 3, 6, 9 months).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

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. Patients with mandibular anterior and premolar hopeless teeth indicated for extraction.
  3. Evaluated bone height on X.Ray to be (0-4 mm buccal bone dehiscence).
  4. Age between 18 and 40 years.
  5. Both sexes.
  6. Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
  7. Highly motivated patients.

Exclusion criteria:

  1. Smokers.
  2. Pregnant or lactating females.
  3. Presence of any pathosis in the pre-implant site.
  4. Presence of Para functional habits.
  5. History of oral radiotherapy.
  6. History of prolonged steroids use
  7. 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mineralized Plasmatic Matrix
MPM(Mineralized plasmatic matrix) insertion in extraction sockets for socket preservation for later implant placement and histomorphometric analysis.
Other: MPM(Mineralized plasmatic matrix).
Preparation of sticky bone graft by addition of growth factors obtained from patient's vebous blood.
Other Names:
  • Sticky bone graft.
ACTIVE_COMPARATOR: Autogenous Bone Graft (Gold Standards).
Socket preservation using Autogenous bone graft for later implant placement and histomorphometric analysis.
Other: Autogenous Bone Graft
Socket preservation using autogenous bone graft for preservation of bone width and height for future implant insertion.
Other Names:
  • Gold Standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Satisfaction regarding function, to be measured using patient questionnaire.
Time Frame: 3 Months.
3 Months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparative histomorphometric analysis, to be measured using a digital software called (leica QWin 500) and unit of measurements are to be (Pixels).
Time Frame: 3 Months.
3 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

September 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

December 26, 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

Other Study ID Numbers

  • CairoSPR-Aut

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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