Poly Tetra Fluro Ethylene vs Native Collagen Membrane for Gbr in Anterior Maxilla

February 12, 2019 updated by: bassam ahmed abd elhameed alkholi, Cairo University

Assessment Of Poly Tetra Fluro Ethylene Membrane Versus Native Collagen Membrane With Guided Bone Regeneration In Atrophic Anterior Maxilla Using (1:1) Of Autogenous Bone And Xenograft Mixture (Randomized Clinical Trial)

evaluation of amount of bone gained in the anterior maxilla using collagen membranes vs ptfe membrane while using a 1:1 mix of xenograft and autogenous bone

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The alveolar bone is formed during tooth eruption, and consists of maxillary and mandibular components that shape and support the alveolar sockets. When teeth are lost, alveolar atrophy occurs, ultimately resulting in a short and narrow alveolar ridge . Such changes in the alveolar bone have a significant effect on prosthetic restoration planning, and are particularly important for areas with esthetic requirements, such as the maxillary incisors. Since preservation of the alveolar bone after extraction makes implant placement and prosthetic restoration easier in the edentulous jaw, alveolar ridge preservation and reconstruction methods using various bone graft materials together with resorbable and non-resorbable membranes have been introduced in order to minimize the loss of alveolar bone after extraction.

Investigations of changes in the alveolar bone after extraction have frequently been performed through clinical measurements and radiographic analysis. In particular, after the extraction of a tooth with fracture or severe periodontitis, the alveolar bone shows severe horizontal and vertical atrophy. The reduction in the width of the alveolar ridge is more notable in the horizontal direction than in the vertical direction, and the buccal wall of the alveolar bone has been reported to undergo greater vertical atrophy than the lingual wall. Changes in the width of the alveolar ridge after extraction occur in a relatively short time, decreasing most rapidly within the first six months after extraction, followed by continual, slow bone resorption over the course of the rest of the patient's life .

When a tooth has been lost, the extent of alveolar bone resorption is affected by a range of factors, including the number of extracted teeth and bone walls, the bone density, the extent of alveolar bone loss, infection, and the presence or absence of adjacent teeth.

Dental implant has become a predictable treatment option, with excellent long-term results. However, the success of implant therapy depends on the amount of bone volume at the insertion site.Unfavorable local conditions may provide insufficient bone volume that negatively affects the prognosis of dental implants. Cawood and Howell in 1988 ranked the atrophy degree of edentulous jaws in six classes. Particularly, atrophies within class IV, also known as "knife-edge" ridges, present a serious horizontal defect, making challenging the placement of regular implants.

Many techniques have been developed to regenerate atrophic alveolar jaws for the placement of dental implants, performed either in combination with graft procedures or in second stage surgery after a period of healing. For many years, bone blocks represented the gold standard to reconstruct the alveolar ridge bone defects. This technique requires to harvest a wide amount of bone to rebuild the atrophic crest.(20). For this reason, bone blocks were often harvested from extra-oral sites with an higher morbidity. Moreover some problems can occur when a combined defects (horizontal and vertical) need to be treated. Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques. To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of both non-resorbable or resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.

Guided bone regeneration or GBR, and guided tissue regeneration or GTR are dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration.

GBR is similar to guided tissue regeneration (GTR) but is focused on development of hard tissues in addition to the soft tissues of the periodontal attachment. At present, guided bone regeneration is predominantly applied in the oral cavity to support new hard tissue growth on an alveolar ridge to allow stable placement of dental implants.

The first application of barrier membranes in the mouth occurred in 1982. in the context of regeneration of periodontal tissues via GTR, as an alternative to resective surgical procedures to reduce pocket depths.Barrier membrane is utilized in GBR technique to cover the bone defect and create a secluded space, which prevents the connective tissue from growing into the space and facilitates the growth priority of bone tissue.

Several surgical techniques via GBR have been proposed regarding the tri-dimensional bone reconstruction of the severely resorbed maxilla, using different types of bone substitutes that have regenerative, osseoinductive or osseoconductive properties which is then packed into the bony defect and covered by resorbable membranes. In cases where augmentation materials used are autografts or allografts the bone density is quite low and resorption of the grafted site in these cases can reach up to 30% of original volume. For higher predictability, nonresorbable titanium-reinforced d-polytetrafluoroethylene (d-PTFE) membranes-as a barrier against the migration of epithelial cells within the grafted site-are recommended.

Non-resorbable membranes retain their shape and structure in the tissues, requiring a second surgical procedure for removal, with consequent additional patient discomfort, and a raise in the costs and duration of the therapy. Non-resorbable membranes include: (i) expanded polytetrafluoroethylene (e-PTFE, Gore-Tex®); (ii) high-density polytetrafluoroethylene (d-PTFE) and (iii) titanium-reinforced expanded polytetrafluoroethylene (Ti-e-PTFE) membranes. The PTFE physico-chemical, thermal, and mechanical properties make it one of the most inert materials.The microstructure of e-PTFE consists of solid nodes interconnected by fine, highly oriented fibrils, providing a unique porous structure. The e-PTFE membranes, first used in 1984, have different structural features at both membrane sides.Effectiveness of e-PTFE membranes was investigated in numerous clinical studies, that confirmed their excellent biocompatibility, leading to a significant bone regeneration after 3- and 6-month healing period .However, drawbacks of e-PTFE membranes are (i) the need for a second surgical procedure and (ii) membrane stiffness that may result in soft tissue dehiscence (which is the cause of failure during the first 3 weeks after membrane implantation), allowing the exposure of the membrane to bacterial infection.

The d-PTFE membrane, developed in 1993, is a non-resorbable membrane, consisting of a high-density PTFE having submicron (0.2 μm) pores. The d-PTFE membranes do not require primary closure and preserve the full width of keratinized mucosa, producing an interesting advantage in respect to e-PTFE. Compared to e-PTFE membranes, the macroporosity of which enhances bacterial colonization upon exposure .the density of the d-PTFE membranes (i) prevents the infections as widely described by different authors .and (ii) makes membranes easy to be removed.

Titanium-reinforced barrier membranes were introduced (Cytoplast® TI-250 Titanium-Reinforced) by Jovanovic and Nevins . who reported the superior regenerative ability of these membranes in respect to the conventional e-PTFE ones. The titanium reinforcement provides mechanical support to the overlying soft tissue preventing its collapse into the defect. In addition, during the surgical procedure, titanium struts permit the surgeon to easily place the membrane under flaps with minimal dissection and flap reflection Native collagen membranes have rapid biodegradation by the enzymatic activity of macrophages and polymorphonuclear leucocytes occurs when using them. these membranes are well documented and have excellent results . they have good tissue integration and vascularization from periosteal side.there is a debate about what is more important biocompatibility or resorption time . The most important commercial collagen membrane is Bio-Gide®, which is based on Xenogenic collagen Type I form porcine skin and is characterized by a bilayered structure with a dense and a porous layer. The dense layer has a smooth surface able to avoid epithelial cell infiltration into bone defects, while the porous layer allows tissue integration.

Study Type

Interventional

Enrollment (Anticipated)

10

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

Study Contact Backup

  • Name: mohamed atef, professor
  • Phone Number: 01009612708

Study Locations

  • Egypt
    • Manial
      • Giza, Manial, Egypt, 11311
        • Cairo Univeristy
        • Contact:
          • cairo univeristy

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.
  • Both sexes.
  • 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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: guided bone regeneration using ptfe

Augmented anterior maxillary bone ridge using ptfe with 1:1 autogenous bone and xenograft mixture

  • Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
  • 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.

intervention:

  • Flap will be done.
  • In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a ptfe membrane which will be stabilized by tacks.
Procedure: guided bone regenerations

intra oral procedures.

  • Flap will be done.
  • In the study group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
  • In the control group: : bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and 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.
EXPERIMENTAL: collagen membrane
  • Local anesthesia will be given to the patient. intervention:
  • Flap will be done.
  • In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
Procedure: guided bone regenerations

intra oral procedures.

  • Flap will be done.
  • In the study group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
  • In the control group: : bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of bone gained
Time Frame: 6 months
using cbct 6 months after
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone area percentage
Time Frame: 6 months
Histo-morphometric analysis
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

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)

February 26, 2019

Primary Completion (ANTICIPATED)

December 30, 2019

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

December 11, 2018

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

Other Study ID Numbers

  • GBR using ptfe vs collagen

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.

Clinical Trials on Missing Maxillary Anterior Teeth

Clinical Trials on guided bone regenerations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe