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Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla

Primary Purpose

Guided Bone Regeneration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Augmentation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Guided Bone Regeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ridge augmentation by collagen membrane

    augmentation by titanium reinforced PTFE

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Height and width of bone gained
    Height and width of bone gained will be measured from CBCT
    Bone area percentage
    Bone area percentage will be measured by Histo-morphometric analysis

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2019
    Last Updated
    February 12, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03840681
    Brief Title
    Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla
    Official Title
    Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla Using Native Collagen vs Titanium Reinforced Polytetraflouroethelene Membranes Using an Organic Bovine Bone Mineral
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2019 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    September 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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: Improved soft tissue healing, Incorporation of the membranes by the host tissues (depending on material properties), 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Guided Bone Regeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Each patient will be given a code by the researcher ( T.A ) and the observer will be blind to which group this case belongs Patients,evaluators and statistican will be blinded
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ridge augmentation by collagen membrane
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    augmentation by titanium reinforced PTFE
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Augmentation
    Intervention Description
    non invasive technique to increase bone width and eliminate need for second surgery
    Primary Outcome Measure Information:
    Title
    Height and width of bone gained
    Description
    Height and width of bone gained will be measured from CBCT
    Time Frame
    After 6 monthes
    Title
    Bone area percentage
    Description
    Bone area percentage will be measured by Histo-morphometric analysis
    Time Frame
    After 6 monthes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohab f Metwally
    Phone
    00201115709990
    Email
    hobaz90_2000@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed m Atef
    Organizational Affiliation
    Cairo U
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26511187
    Citation
    Lopez MA, Andreasi Bassi M, Confalone L, Carinci F. REGENERATION OF ATROPHIC CRESTAL RIDGES WITH RESORBABLE LAMINA: TECHNICAL NOTE. J Biol Regul Homeost Agents. 2015 Jul-Sep;29(3 Suppl 1):97-100.
    Results Reference
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    17066630
    Citation
    Esposito M, Grusovin MG, Coulthard P, Worthington HV. The efficacy of various bone augmentation procedures for dental implants: a Cochrane systematic review of randomized controlled clinical trials. Int J Oral Maxillofac Implants. 2006 Sep-Oct;21(5):696-710.
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    PubMed Identifier
    15800467
    Citation
    Sorni M, Guarinos J, Garcia O, Penarrocha M. Implant rehabilitation of the atrophic upper jaw: a review of the literature since 1999. Med Oral Patol Oral Cir Bucal. 2005 Apr 1;10 Suppl 1:E45-56. English, Spanish.
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    PubMed Identifier
    12498538
    Citation
    Hoexter DL. Bone regeneration graft materials. J Oral Implantol. 2002;28(6):290-4. doi: 10.1563/1548-1336(2002)0282.3.CO;2.
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    PubMed Identifier
    16968389
    Citation
    Chiapasco M, Zaniboni M, Boisco M. Augmentation procedures for the rehabilitation of deficient edentulous ridges with oral implants. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:136-59. doi: 10.1111/j.1600-0501.2006.01357.x.
    Results Reference
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    Citation
    Karring T, Cortellini P, Lindhe J. Regenerative periodontal therapy. In: Lindhe J, Karring T, Lang NP, editors. Clinical periodontology and implant dentistry. Copenhagen: Munksgaard, 1997: 597-646.
    Results Reference
    background
    PubMed Identifier
    9197097
    Citation
    Schliephake H, Kracht D. Vertical ridge augmentation using polylactic membranes in conjunction with immediate implants in periodontally compromised extraction sites: an experimental study in dogs. Int J Oral Maxillofac Implants. 1997 May-Jun;12(3):325-34.
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    PubMed Identifier
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    Becker W, Dahlin C, Becker BE, Lekholm U, van Steenberghe D, Higuchi K, Kultje C. The use of e-PTFE barrier membranes for bone promotion around titanium implants placed into extraction sockets: a prospective multicenter study. Int J Oral Maxillofac Implants. 1994 Jan-Feb;9(1):31-40.
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    Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla

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