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Bone Changes in Atrophic Maxilla Treated by Split-crest Technique

Primary Purpose

Atrophy; Edentulous Ridge

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ridge splitting, immediate implant, Nanobone with PRF.
Ridge splitting, immediate implantand PRF.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy; Edentulous Ridge

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18-70.
  • Patients with an edentulous site in maxilla.
  • Ridge width of <6mm at the edentulous site.
  • Ridge height of >9mm at the edentulous site.
  • Patients who are compliant to oral hygiene measures for 4 weeks.
  • Patient consent approval and signing.

Exclusion Criteria:

  • Smokers.
  • Systemic disease that contraindicates implant placement or surgical procedures.
  • No or poor patient's compliance.
  • History of radio or chemo-therapy.
  • Psychological problems.
  • Pathology at the site of intervention.
  • Pregnancy.
  • Insufficient crown height space or mesio-distal dimension that contradict the placement of a dental implant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Test group

    Arm Description

    Ridge splitting, immediate implantand PRF.

    Ridge splitting, immediate implant, Nanobone with PRF.

    Outcomes

    Primary Outcome Measures

    Horizontal bone gain in millimeters
    using Cone beam computed tomography

    Secondary Outcome Measures

    Post-operative pain Using Numerical rating scale
    Post-operative swelling Using Descriptive 4-point scale of swelling

    Full Information

    First Posted
    July 11, 2016
    Last Updated
    January 13, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02836678
    Brief Title
    Bone Changes in Atrophic Maxilla Treated by Split-crest Technique
    Official Title
    Bone Changes in Atrophic Maxilla Treated by Split-crest Technique and Dental Implants With Platelet Rich Fibrin and Nanobone® Versus Platelet Rich Fibrin Alone; Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    September 2018 (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

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The effect of adding Nanobone on horizontal bone gain in ridge splitting.
    Detailed Description
    In cases of a very narrow ridge, One of the augmentation protocols is alveolar ridge-splitting techniques (RST) or alveolar ridge expansion techniques with simultaneous implant insertion. The piezoelectric surgical devices implemented for conducting bone osteotomy through the use of micrometric ultrasonic vibrations have been widely used in recent years in maxillofacial surgery. Its biggest advantages are that it allows for cutting with micrometric sensitivity while cutting hard tissues, it offers a clear vision of the surgical site due to its cavitation effect, it does not cause any damage to the soft tissues while performing these cuts, and that the bone tissue heals more quickly and seamlessly, after the cuts made by piezosurgery device. The fully synthetic bone substitute, NanoBone® (Artoss, Rostock, Germany), which will be applied in this clinical study, is basically a nanocrystalline hydroxyapatite embedded in a silica gel matrix, achieved by means of specific sol-gel techniques. Features such as interconnecting pores on the nanoscale, the open SiOH or SiO groups of polysilicic acid, its large internal surface, and the high porosity of this biomaterial are all related to the calcification processes observed within the implantation bed. While the HA component is responsible for NanoBone osteoconductive properties, the silica component is believed to induce connective tissue formation, osteoblast proliferation, bone matrix mineralization, and calcification, thus combining osteoconductive and osteoinductive properties. This phenomenon is associated with the rearrangement of the silica matrix, which could be observed in vivo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrophy; Edentulous Ridge

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Ridge splitting, immediate implantand PRF.
    Arm Title
    Test group
    Arm Type
    Experimental
    Arm Description
    Ridge splitting, immediate implant, Nanobone with PRF.
    Intervention Type
    Biological
    Intervention Name(s)
    Ridge splitting, immediate implant, Nanobone with PRF.
    Intervention Description
    Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis). Alloplast bone graft material (Nanobone) PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue).
    Intervention Type
    Biological
    Intervention Name(s)
    Ridge splitting, immediate implantand PRF.
    Intervention Description
    Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis). PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue).
    Primary Outcome Measure Information:
    Title
    Horizontal bone gain in millimeters
    Description
    using Cone beam computed tomography
    Time Frame
    5 month
    Secondary Outcome Measure Information:
    Title
    Post-operative pain Using Numerical rating scale
    Time Frame
    2 weeks
    Title
    Post-operative swelling Using Descriptive 4-point scale of swelling
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age: 18-70. Patients with an edentulous site in maxilla. Ridge width of <6mm at the edentulous site. Ridge height of >9mm at the edentulous site. Patients who are compliant to oral hygiene measures for 4 weeks. Patient consent approval and signing. Exclusion Criteria: Smokers. Systemic disease that contraindicates implant placement or surgical procedures. No or poor patient's compliance. History of radio or chemo-therapy. Psychological problems. Pathology at the site of intervention. Pregnancy. Insufficient crown height space or mesio-distal dimension that contradict the placement of a dental implant.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maged Anis, Assisstant lecturer
    Phone
    00201000618605
    Email
    magedwadie@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rasha Attia, Assisstant lecturer
    Phone
    00201009032255
    Email
    periorasha1@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amr Zahran, Professor
    Organizational Affiliation
    Professor of Oral Medicine, Periodontology and Oral Diagnosis
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ahmed Reda, Lecturer
    Organizational Affiliation
    Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    Gerber, T., Holzhüter, G., Knoblich, B., Dörfling, P., Bienengräber, V., & Henkel, K. O. (2000). Development of bioactive sol-gel material template for in vitro and in vivo synthesis of bone material. Journal of Sol-Gel Science and Technology, 19(1-3), 441-445. http://doi.org/10.1023/A:10087995
    Results Reference
    background
    PubMed Identifier
    14980425
    Citation
    Porter AE, Patel N, Skepper JN, Best SM, Bonfield W. Effect of sintered silicate-substituted hydroxyapatite on remodelling processes at the bone-implant interface. Biomaterials. 2004 Jul;25(16):3303-14. doi: 10.1016/j.biomaterials.2003.10.006.
    Results Reference
    background

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    Bone Changes in Atrophic Maxilla Treated by Split-crest Technique

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