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Comparison of Autogenous Bone Graft and Screw Tent-Pole Technique on Atrophic Mandible

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autogenous block bone graft
i-PRF enriched allograft material+ screw tent pole technique
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring Bone augmentation, Autogenous block bone graft, Leukocytes and platelet-rich fibrin, Injectable platelet rich fibrin, Tent-pole technique

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who refused to use a partially removable prosthesis and requested dental implant treatment,
  • Patients had bilateral, moderate or severe posterior atrophic mandible,
  • Patients had precluded conditions suitable for short dental implant.

Exclusion Criteria:

  • Patients who had systemic diseases (osteoporosis, hemophilia, anemia, etc.),
  • Patients who required drugs (bisphosphonate or steroid therapy),
  • Patients who had a smoking habit,
  • Patients who had received radiation therapy within the last two years,
  • Patients who were under 18 years old, pregnant or lactating,
  • Patients who had a total platelet count lower than 150,000/mm3.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Autogenous block bone graft

    i-PRF enriched allograft material+screw tent pole technique

    Arm Description

    Surgical site as control group was treated with autogenous block bone graft. Augmentation site was covered with a mixture of particulate allograft and leukocyte and platelet-rich fibrin (L-PRF) membrane.

    Surgical site as test group was treated with injectable platelet rich-fibrin (i-PRF) enriched allograft material. To avoid soft tissue collapse, screws were used. Augmentation site was covered with leukocyte and platelet-rich fibrin (L-PRF) membrane.

    Outcomes

    Primary Outcome Measures

    Assessment of radiological changes
    Radiologic analysis was performed to compare the changes in height of alveolar bone between the study groups
    Histological assessment
    Bone core samples were harvested from the implant placement sites for calculate the relative quantification of newly-formed bone within both groups as a percentage

    Secondary Outcome Measures

    Clinical assessment
    Implant survival
    Clinical assessment
    Incidence of nerve damage were analyzed by six different sensory tests carried out three times for each evaluation area on the chin

    Full Information

    First Posted
    October 16, 2019
    Last Updated
    January 14, 2020
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04133090
    Brief Title
    Comparison of Autogenous Bone Graft and Screw Tent-Pole Technique on Atrophic Mandible
    Official Title
    Comparison of Treatment Outcomes of Autogenous Block Bone Graft and Screw Tent-Pole Technique in Combination With Injectable Platelet Rich-Fibrin on Posterior Atrophic Mandible: A Split-Mouth Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 11, 2016 (Actual)
    Primary Completion Date
    October 8, 2018 (Actual)
    Study Completion Date
    July 6, 2019 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of the present study was to assess the effect of injectable platelet-rich fibrin (i-PRF) enriched with allograft on alveolar bone regeneration when compared with autogenous block bone graft, in the same participants. The study was designed as a split-mouth randomized controlled trial. The patients were randomly assigned to one of two surgical groups: the test group with i-PRF enriched particulate allograft using the screw tent-pole technique; and the control group with autogenous block bone harvested from the ramus area. All augmentation sites covered by leukocytes-PRF (L-PRF) membrane. The primary outcome variable of this study was the radiographic and histologic data collected at postoperative 6 months. The secondary outcome variable was nerve alterations and implant survival.
    Detailed Description
    Alveolar bone loss which results from tooth extraction, trauma or age-related factors, gives rise to the functional or structural inefficiency of implant-supported prosthetic rehabilitation. Therefore, bone augmentation techniques and graft materials are required to improve esthetic outcomes and long-term prognosis of dental implant treatment. The purpose of the present study is to evaluate the effect of i-PRF enriched with allograft on bone regeneration when compared with autogenous block bone graft. The hypothesis of the study is that i-PRF enriched with allograft will provide similar results to autogenous block bone graft for three dimensional bone reconstruction. This split-mouth randomized study was conducted in the Department of Oral Surgery of the School of Dentistry. The research protocol and informed consent forms for all procedures on patients, were approved by the local ethics committee of the University in accordance with the Helsinki Declarations of 1983.Selection of the participants was determined by clinical and radiological examination according to the inclusion criteria.Before augmentation surgery, the treatment allocation of bilateral posterior atrophic mandibles were randomly assigned to one or other of the two surgical sides: either the test group ( i-PRF + particulate allograft with screw tent-pole technique + L-PRF) or the control group (autogenous block bone graft + L-PRF) by use of the computer-generated method. Blood samples from thirteen participants were collected by a nurse at the beginning of the surgery.The L-PRF preparation was performed as follows; the venous blood samples were collected in 9 ml x 4 glass tubes without anticoagulant and immediately centrifuged at 2700 rpm for 12 min. After the centrifugation of the samples, the red blood cells (RBC) and platelet-poor plasma (PRP) were separated from the 'buffy coat' described as L-PRF. Then the L-PRF was placed on a special press kit to obtain membrane form. Non-coated, 8 ml plastic tube without anticoagulant was immediately centrifuged at 2700 rpm for 2 min to obtain i-PRF. Following centrifugation, i-PRF was collected the tube by using a disposable syringe and mixed with allograft material. All surgeries were performed under local anesthesia. A mid-crestal incision was made on either side to expose the edentulous alveolar ridge. Furthermore, a posterior releasing incision was made over the external oblique ridge to provide access to the donor site, in control group. Control site was treated with autogenous block bone graft and the opposite side (test site) was treated with I-PRF enriched allograft material. L-PRF membrane was used to cover augmentation sites. The primary outcome variables of this study were the radiographic changes of augmented bone at postoperative 6 months as well as the percentage of newly formed bone, graft material and residual bone in the groups. The secondary outcome variables were the clinical data on implant survival rate and nerve alterations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alveolar Bone Loss
    Keywords
    Bone augmentation, Autogenous block bone graft, Leukocytes and platelet-rich fibrin, Injectable platelet rich fibrin, Tent-pole technique

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Split-mouth study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Autogenous block bone graft
    Arm Type
    Active Comparator
    Arm Description
    Surgical site as control group was treated with autogenous block bone graft. Augmentation site was covered with a mixture of particulate allograft and leukocyte and platelet-rich fibrin (L-PRF) membrane.
    Arm Title
    i-PRF enriched allograft material+screw tent pole technique
    Arm Type
    Active Comparator
    Arm Description
    Surgical site as test group was treated with injectable platelet rich-fibrin (i-PRF) enriched allograft material. To avoid soft tissue collapse, screws were used. Augmentation site was covered with leukocyte and platelet-rich fibrin (L-PRF) membrane.
    Intervention Type
    Procedure
    Intervention Name(s)
    Autogenous block bone graft
    Intervention Description
    Vertical and horizontal osteotomies were performed by means of a 6-mm diameter separation disc under copious irrigation with saline.The harvested bone graft was immediately placed in sterile saline solution to prevent dehydration. Sharp edges around the block graft were rounded under saline irrigation using a 4-mm round bur. The screw holes were properly made on both the recipient site and the block graft using a 1.3 mm drill. The graft was firmly fixed with 1.3 mm screws and a compatible driver. The periphery of the graft and the underlying gap between the screws and the recipient site, were covered with a mixture of particulate allograft and sterile saline solution to minimize resorption and to improve the adaption of the graft. All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture.
    Intervention Type
    Procedure
    Intervention Name(s)
    i-PRF enriched allograft material+ screw tent pole technique
    Intervention Description
    The i-PRF preparation was performed as follows: the blood sample collected in an 8 ml, non-coated plastic tube without anticoagulant was immediately centrifuged at a protocol of 2700 rpm for 2 min. After centrifugation, the liquid autologous fibrin material which comprised the 1 mL upper layer of the tube was collected, using a disposable syringe. The screw holes were made on the recipient site using a 1.3 mm drill. 7 mm long screws were fixed 2mm or 4mm higher than on the recipient site to provide the desired augmentation distance and stabilized by a compatible driver. i-PRF was mixed with allograft material in a sterile metal box. Polymerization was done in 3 to 5 minutes, then this material was applied to the underlying gap between the screws and the recipient site.All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture.
    Primary Outcome Measure Information:
    Title
    Assessment of radiological changes
    Description
    Radiologic analysis was performed to compare the changes in height of alveolar bone between the study groups
    Time Frame
    Change of alveolar bone height at 6 months
    Title
    Histological assessment
    Description
    Bone core samples were harvested from the implant placement sites for calculate the relative quantification of newly-formed bone within both groups as a percentage
    Time Frame
    Postoperatively 6 months
    Secondary Outcome Measure Information:
    Title
    Clinical assessment
    Description
    Implant survival
    Time Frame
    6 months, 12 months
    Title
    Clinical assessment
    Description
    Incidence of nerve damage were analyzed by six different sensory tests carried out three times for each evaluation area on the chin
    Time Frame
    1 month, 6 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who refused to use a partially removable prosthesis and requested dental implant treatment, Patients had bilateral, moderate or severe posterior atrophic mandible, Patients had precluded conditions suitable for short dental implant. Exclusion Criteria: Patients who had systemic diseases (osteoporosis, hemophilia, anemia, etc.), Patients who required drugs (bisphosphonate or steroid therapy), Patients who had a smoking habit, Patients who had received radiation therapy within the last two years, Patients who were under 18 years old, pregnant or lactating, Patients who had a total platelet count lower than 150,000/mm3.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Autogenous Bone Graft and Screw Tent-Pole Technique on Atrophic Mandible

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