Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla

February 12, 2019 updated by: Mohab Fathy Metwally, Cairo University

Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla Using Native Collagen vs Titanium Reinforced Polytetraflouroethelene Membranes Using an Organic Bovine Bone Mineral

Guided bone regeneration (GBR) is a surgical technique that uses barrier membranes to promote osteoblast cells proliferation and exclude other cells such as epithelium and connective tissue cells. GBR is often combined with bone grafting procedures.

Using Absorbable membranes like collagen membrane will reduce treatment time by decreasing need for second surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla using native Collagen vs Titanium Reinforced Polytetraflouroethelene Membranes using an organic bovine Bone mineral.Reconstructive surgery is necessary before implant placement to regenerate bone defects caused by atrophy, dental trauma, extractions or periodontal disease . Success rate of implants is related to the correct position and angulation of implants in residual crest, so that height and thickness of bone augmentation can allow predictable results ,With this in mind, it is important to establish sound clinical concepts with clearly defined parameters that lead to successful esthetics in the anterior maxilla, with long-term stability of the peri-implant tissues.

The most popular surgical procedures to obtain bone augmentation are: bone grafts, guided bone regeneration, maxillary sinus floor elevation, and bone osteogenesis distraction.

Guided bone regeneration (GBR) is a surgical technique that uses barrier membranes to promote osteoblast cells proliferation and exclude other cells such as epithelium and connective tissue cells. GBR is often combined with bone grafting procedures.

Bone grafts are integrated into native bone with three different processes: osteogenesis, osteoinduction and osteoconduction; Osteogenesis is the formation of new bone from osteocompetent cells and is the only process where the graft itself can induce Bone augmentation, Osteoinduction induces Bone Augmentation from the differentiation and stimulation of mesenchymal cells by the bone-inductive proteins, Osteoconduction is the formation of Bone Augmentation along a scaffold from osteocompetent cells of the recipient site .

There are 2 Types of membranes:

III. Non Resorbable membrane IV. Resorbable membrane

Non-resorbable membranes:

With the presentation of the first successful GBR procedures and the subsequent wide and successful application of ePTFE membranes, this material became a standard for bone regeneration. Expanded PTFE is characterized as a polymer with high stability in biological systems. It resists breakdown by host tissues and by microbes and does not elicit immunologic reactions. A frequent complication with membrane application in conjunction with implants is membrane exposure and infection Wound dehiscence and membrane exposure have been reported to impair the amount of bone regenerated in a number of experimental animal and clinical investigations

Bioresorbable membranes:

The requirement of second surgical procedure for the removal of Non Resorbable barrier membrane(NRBM) led to the introduction of bioresorbable barrier membranes (RBM). The advantages of RBM compared to NRBM were as follows:

  1. Improved soft tissue healing,
  2. Incorporation of the membranes by the host tissues (depending on material properties),
  3. Quick resorption in case of exposure, eliminating bacterial contamination. Today, a lot of RBM are commercially available including collagen, freeze-dried fascia lata, freeze-dried dura mater allografts, polyglactin-acid, polylactic acid, polyglycolic acid, polyorthoester, polyurethane, polyhydroxybutyrate, etc.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Patients with atrophied anterior maxillary ridge area.

    • Age: 18 years and older.
    • No intraoral soft and hard tissue pathology.
    • No systemic condition that contraindicate bone augmentation

Exclusion Criteria:

  • Heavy smokers more than 20 cigarettes per day.(32)
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
  • Pregnant or nursing women.
  • Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
  • Patient with previous history of radiotherapy.

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: Ridge augmentation by collagen membrane
  • Intra operative procedures (for both groups) followed by CBCT will be taken for every patient.
  • Local anesthesia will be given to the patient.
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • Flap will be done.
  • bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed at defected area then covered at the defected area by a collagen membrane which will be stabilized by tacks.
  • The site will then be copiously irrigated with saline in preparation for closure.
  • The flap will then be closed using interrupted 4/0 resorbable sutures.
Other: Augmentation
non invasive technique to increase bone width and eliminate need for second surgery
Active Comparator: augmentation by titanium reinforced PTFE
  • Intra operative procedures (for both groups) followed by CBCT will be taken for every patient.
  • Local anesthesia will be given to the patient.
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • Flap will be done.
  • bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed at the defected area then covered by a titanium reinforced polytetraflouroethelene membrane which will be stabilized by tacks.
  • The site will then be copiously irrigated with saline in preparation for closure.
  • The flap will then be closed using interrupted 4/0 resorbable sutures.
Other: Augmentation
non invasive technique to increase bone width and eliminate need for second surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height and width of bone gained
Time Frame: After 6 monthes
Height and width of bone gained will be measured from CBCT
After 6 monthes
Bone area percentage
Time Frame: After 6 monthes
Bone area percentage will be measured by Histo-morphometric analysis
After 6 monthes

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed m Atef, Cairo U

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMetwally

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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