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Biphasic Material With PRF in Lateral Sinus Floor Augmentation

Primary Purpose

Maxillary Sinus Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lateral sinus floor augmentation
Biphasic Calcium Phosphate
Injectable platlets rich fibrin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Sinus Disease focused on measuring sinus floor augmentation, biphasic calcium phosphate, PRF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Residual bone crest height < 5 mm and width≥6 mm in the planned implant site. Healed bone crest (at least 6 months elapsed from tooth loss/extraction); Exclusion Criteria: Absolute medical contraindications to implant surgery such as uncontrolled diabetes mellitus, blood platelet disorders, serious osseous disorders, and cardiac arrhythmia; history of bone grafting in the posterior maxilla, immunocompromised patients, taking corticosteroids, taking aspirin before the procedure, positive history of chemotherapy and radiotherapy, and maxillary sinus pathologies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1 BCP alone

    Group 2 BCP with I-PRF

    Arm Description

    Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application

    Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application with addition of injectable platlet rich fibrin I-PRF

    Outcomes

    Primary Outcome Measures

    Vertical bone gain BG
    Vertical bone gain (BG) 6 months after sinus augmentation in both height and density aspects by cone beam CT

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2023
    Last Updated
    October 6, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06071416
    Brief Title
    Biphasic Material With PRF in Lateral Sinus Floor Augmentation
    Official Title
    The Lateral Approach Maxillary Sinus Floor Augmentation Using Biphasic Material Combined With Injectable Platelet Rich Fibrin- Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    March 15, 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    A lack of bone in the posterior maxilla, mainly resulting from the combination of alveolar bone resorption after tooth loss, pneumatization of the maxillary sinus, and periodontal disease, leads to increased difficulty during dental implant treatment. The classic technique for maxillary sinus floor augmentation entails the preparation of the trap door to elevate the schneiderian membrane in the lateral sinus wall. it can be done either in a single stage with simultaneous implant placement or in two stages with delayed implant placement, depending on the available residual alveolar ridge height that necessary for implant primary stability. The new compartment created between the floor of maxillary sinus and the elevated membrane was filled with either autogenous, allografts, xenograft or combination of them to maintain space for new bone formation. The disadvantages of such methods are high costs for grafting material, time consuming and high morbidity, because harvesting of bone grafts is needed.
    Detailed Description
    Recently, a systematic review demonstrated the effectiveness of synthetic bone materials, including biphasic calcium phosphate (BCP), as substitutes for autogenous bone. BCP consists of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP). In contrast with stable HA, β-TCP is highly resorptive and is replaced by newly formed bone; therefore, the resorption rate of BCP could be influenced by the ratio of HA and β-TCP. platelet-rich fibrin (PRF) was recently introduced as additional or replacement materials in bone augmentation procedures. The use of biologic mediators with osteoinductive properties has been considered to reduce the time interval and accelerate the formation of new bone. The strengths of PRF in reducing tissue inflammation, promoting the vascularization of bone tissue, accelerating new bone formation, and improving scaffold mechanics have been reported.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maxillary Sinus Disease
    Keywords
    sinus floor augmentation, biphasic calcium phosphate, PRF

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group I, patients undergo sinus lifting using bone substitute BCP alone. -Group II, patients who undergo sinus lifting using BCP with I-PRF.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    using automated sequence generation ( randomizer. org) patients will be divided into the two groups ,In sequentially numbered , opaque, sealed envelopes, participants will be enrolled and evaluated while the allocation sequence will be kept a secret from the researchers.
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 BCP alone
    Arm Type
    Active Comparator
    Arm Description
    Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application
    Arm Title
    Group 2 BCP with I-PRF
    Arm Type
    Active Comparator
    Arm Description
    Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application with addition of injectable platlet rich fibrin I-PRF
    Intervention Type
    Procedure
    Intervention Name(s)
    Lateral sinus floor augmentation
    Intervention Description
    maxillary sinus floor augmentation by lateral approach
    Intervention Type
    Drug
    Intervention Name(s)
    Biphasic Calcium Phosphate
    Intervention Description
    appliaction of BCP bone substitute
    Intervention Type
    Procedure
    Intervention Name(s)
    Injectable platlets rich fibrin
    Intervention Description
    centrifuge 10 ml of patient blood to get I-PRF that applied to the bone substitute
    Primary Outcome Measure Information:
    Title
    Vertical bone gain BG
    Description
    Vertical bone gain (BG) 6 months after sinus augmentation in both height and density aspects by cone beam CT
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Residual bone crest height < 5 mm and width≥6 mm in the planned implant site. Healed bone crest (at least 6 months elapsed from tooth loss/extraction); Exclusion Criteria: Absolute medical contraindications to implant surgery such as uncontrolled diabetes mellitus, blood platelet disorders, serious osseous disorders, and cardiac arrhythmia; history of bone grafting in the posterior maxilla, immunocompromised patients, taking corticosteroids, taking aspirin before the procedure, positive history of chemotherapy and radiotherapy, and maxillary sinus pathologies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alzahraa Alghriany, Lecturer
    Phone
    +201203770058
    Email
    alghriany@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Mortada Fikry, Associate professor
    Phone
    +201005432223
    Email
    mortadafikry@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Biphasic Material With PRF in Lateral Sinus Floor Augmentation

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