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Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization

Primary Purpose

Edentulous Alveolar Ridge

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use of Densah Burs in closed sinus lift
Closed sinus lift using osteotomes
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring Densah Burs, Osteotomes, Sinus Tenting, Graftless

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No inflamed sinus
  • Minimum alveolar ridge height 5-6 mm
  • Medical free
  • Both genders males and females.

Exclusion Criteria:

  • Remaining alveolar ridge height is less than 5mm
  • Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.

    • Subjected to irradiation in the head and neck area less than 1 year before implantation.
    • Patients having history of allergy to any drugs.
    • Patients who have a history of any concomitant from a major known medical problem and/or ongoing pharmacologic treatments
    • Untreated periodontitis.
    • Poor oral hygiene and motivation.
    • Uncontrolled diabetes.
    • Pregnant or nursing.
    • Substance abuse.
    • Psychiatric problems or unrealistic expectations.
    • Severe bruxism or clenching.
    • Immunosuppressed or immunocompromised.
    • Treated or under treatment with intravenous amino-bisphosphonates.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Closed sinus lift using Densah bur

    Conventional closed sinus lift using osteotomes

    Arm Description

    Closed sinus lifting will be performed using densah burs and then dental implants will be placed.

    Sinus lifting will be performed using osteotomes and then dental implants will be placed.

    Outcomes

    Primary Outcome Measures

    Measurement of Bone Change in Cone Beam CT
    The amount of bone change will be determined by superimposing pre-operative CBCT (cone-beam computed tomography), three months post-operative, and six months post-operative CBCT.

    Secondary Outcome Measures

    Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)
    The implant stability quotient (ISQ) of the implants will be measured using a resonance frequency analysis measuring device, that is, Ostell, at the time of placement, which is the primary stability, and after six months, which is the secondary stability. The implant stability quotient has a scale ranging from 0 to 100 in which 0 is a failed implant and 100 is maximum implant stability.

    Full Information

    First Posted
    June 27, 2022
    Last Updated
    August 20, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05513170
    Brief Title
    Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization
    Official Title
    Graftless Closed Sinus Tenting Using Dental Implants After Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Sinus Pneumatization: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (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

    5. Study Description

    Brief Summary
    Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Introducing new intervention of Densah Burs helps increase bone gain around implant and decrease the patient discomfort.
    Detailed Description
    The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Maxillary sinus lift is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Trans-crestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was first in 1994, and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found to yield predictable results with success rates of at least 95%. Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and auto grafted into open marrow spaces and osteotomy site walls in outwardly expanding directions. It was reported that osseodensification increases the bone-implant contact, bone density, and primary stability. Moreover, the insertion torque peak is directly related to implant primary stability and host bone density. Furthermore, for every 9.8 N cm of torque increased, a reduction in failure rate of 20% in single-tooth implant restoration was observed. The objective of this study is to evaluate crestal sinus elevation using osseodensification versus osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary stability and bone gain around the implant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous Alveolar Ridge
    Keywords
    Densah Burs, Osteotomes, Sinus Tenting, Graftless

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients' data will be enrolled in database of the Outpatient clinics of the Department of Oral and maxillofacial surgery, Faculty of Dentistry, Cairo University. If there is a potential eligibility, the patient will be examined thoroughly as described before. Consecutive sampling is done through screening of patients. This will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    This trial is considered a randomized double blind clinical trial due to the following: The participant will be blinded to the technique that will be used during the surgical operation. The outcome assessor will be blinded The operator (DR.B.S.) will not be blinded for both techniques during the surgical operation, as the two techniques are different. (Dr. M.O.). The purpose of double blinding procedure is to reduce assessment bias and to increase accuracy and objectivity of clinical outcomes
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Closed sinus lift using Densah bur
    Arm Type
    Active Comparator
    Arm Description
    Closed sinus lifting will be performed using densah burs and then dental implants will be placed.
    Arm Title
    Conventional closed sinus lift using osteotomes
    Arm Type
    Active Comparator
    Arm Description
    Sinus lifting will be performed using osteotomes and then dental implants will be placed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Use of Densah Burs in closed sinus lift
    Intervention Description
    Closed sinus will be performed using Densah Burs. Densah Burs enhance bone quality through osseodensification; a process through which bone is compacted and auto-graphted in the marrow spaces and apically to elevate the sinus floor and enhance bone density.
    Intervention Type
    Procedure
    Intervention Name(s)
    Closed sinus lift using osteotomes
    Intervention Description
    Closed sinus lift will be performed using osteotomes. Osteotomes elevate the sinus floor and enhance the bone quality.
    Primary Outcome Measure Information:
    Title
    Measurement of Bone Change in Cone Beam CT
    Description
    The amount of bone change will be determined by superimposing pre-operative CBCT (cone-beam computed tomography), three months post-operative, and six months post-operative CBCT.
    Time Frame
    three and six months
    Secondary Outcome Measure Information:
    Title
    Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)
    Description
    The implant stability quotient (ISQ) of the implants will be measured using a resonance frequency analysis measuring device, that is, Ostell, at the time of placement, which is the primary stability, and after six months, which is the secondary stability. The implant stability quotient has a scale ranging from 0 to 100 in which 0 is a failed implant and 100 is maximum implant stability.
    Time Frame
    At the day of implant placement and after six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: No inflamed sinus Minimum alveolar ridge height 5-6 mm Medical free Both genders males and females. Exclusion Criteria: Remaining alveolar ridge height is less than 5mm Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study. Subjected to irradiation in the head and neck area less than 1 year before implantation. Patients having history of allergy to any drugs. Patients who have a history of any concomitant from a major known medical problem and/or ongoing pharmacologic treatments Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised. Treated or under treatment with intravenous amino-bisphosphonates.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman M Anwar, Professor
    Phone
    +20223642705
    Ext
    522
    Email
    rec@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16274152
    Citation
    Ottoni JM, Oliveira ZF, Mansini R, Cabral AM. Correlation between placement torque and survival of single-tooth implants. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):769-76.
    Results Reference
    background
    PubMed Identifier
    8055503
    Citation
    Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
    Results Reference
    background
    Links:
    URL
    https://edj.journals.ekb.eg/article_71261_ed987b0840ffacb78fc722592cb620ed.pdf
    Description
    Clinical and radiographic evaluation of osseodensification versus osteotome for sinus floor elevation in partially atrophic maxilla: A prospective long term study
    URL
    https://clinicaltrials.gov/ct2/show/NCT03559777
    Description
    Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome
    URL
    https://adjc.journals.ekb.eg/article_165194_0f7e7df22Scb83b2ace99f7d370d885c.pdf
    Description
    Patient Perception and Radiographic Assessment of Sinus Lifting Procedure using Densah Bur versus Osteotome-mediated sinus lifting: A Randomized Clinical Trial

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    Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization

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