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Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment

Primary Purpose

Edentulous Alveolar Ridge

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

About this trial

This is an interventional other trial for Edentulous Alveolar Ridge

Eligibility Criteria

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

Inclusion Criteria:

  • completely edentulous patient.
  • Age range from 40 to 70 year old
  • Skeletal class 1
  • Both sexes.

Exclusion Criteria:

  • No intra oral soft and hard tissue pathology
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Patient with sever parafunctional occlusal activity.
  • Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability,.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    dome magnetic attachment

    flat magnetic attachment

    Arm Description

    A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed. Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor We connect magnetic attachment(dome) for each groups on complete denture by pick up procedure at day of implant installation

    A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed. Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor We connect magnetic attachment(flat) for each groups on complete denture by pick up procedure at day of implant installation

    Outcomes

    Primary Outcome Measures

    name of measurement: Patient satisfaction
    Denture satisfaction questionnaire
    name of measurement: Patient satisfaction
    Denture satisfaction questionnaire

    Secondary Outcome Measures

    name of measurement: implant stability
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe.
    name of measurement: implant stability
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe.
    name of measurement: implant stability
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
    name of measurement: implant stability
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
    name of measurement: implant stability
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.

    Full Information

    First Posted
    June 15, 2020
    Last Updated
    June 17, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04438616
    Brief Title
    Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment
    Official Title
    Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment for Implant Retained Mandibular Over Denture Following Immediate Loading
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    January 30, 2021 (Anticipated)
    Study Completion Date
    April 30, 2021 (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
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Patients were randomly divided in to two groups by using computerized software ; the first group received flat magnetic attachment design while the second group received dome magnetic attachment design.which the inclusion criteria is completely edentulous patient ,Age range from 40 to 70 year old ,skeletal class 1, both sexes Implant stability will be measured for both groups using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks. Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire
    Detailed Description
    The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group flat magnetic attachment design and study group dome magnetic attachment design technique Radiographic examination included a preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis. All patients will receive complete denture before implant installation .Constructed as the following Primary impression to construct diagnostic cast and special tray . Secondary impression with selective pressure impression technique to have master caste and occlusion block Face bow transfer and centric relation record will be utilized to mount the master cast on semi adjuctable articulator ,then setting the teeth and trying the denture in patient mouth. Processing of acrylic and lab remounting ,then delivery of the denture. The complete denture will be duplication to be used as a guide to fabricate the radiographic stent after placement radio opaque marker in two lower canines then send patient to perform CBCT and these duplicate denture use as surgical template to place two implant. CBCT machine: planmeca / CBCT soft ware : blue sky / FOV: single arch mandible /voxel size :400 Mm ( KV:90 / MA: 8 / S:11,997) The CBCT examination where performed in radiology department / collage of dentistry /cairo university serial follow up CBCT not need Patients were randomly divided in to two groups by using computerized software ; the first group received flat magnetic attachment design while the second group received dome magnetic attachment design e. All surgeries were performed by the same prosthodontic. All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine). A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed. Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor.(control and study groups) The flap will then be closed using interrupted 4/0 resorbable sutures. We connect magnetic attachment(flat,dome) for each groups on complete denture by pick up procedure at day of implant installation. Relief space from the denture for the magnetic attachment will be made and a rubber dam will be used to closed the under cute under the magnetic attachment. pickup material will be added in the relief area to connect the housing to the denture intra orally. Implant stability will be measured for both groups using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks. Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dome magnetic attachment
    Arm Type
    Active Comparator
    Arm Description
    A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed. Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor We connect magnetic attachment(dome) for each groups on complete denture by pick up procedure at day of implant installation
    Arm Title
    flat magnetic attachment
    Arm Type
    Active Comparator
    Arm Description
    A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed. Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor We connect magnetic attachment(flat) for each groups on complete denture by pick up procedure at day of implant installation
    Intervention Type
    Procedure
    Intervention Name(s)
    dome magnetic attachment
    Intervention Description
    All patients will receive complete denture before implant installation . The CBCT examination should be take patients received infiltration local anesthesia A crestal incision is made using No. 15 c blade . Full sequential drilling under copious saline irrigation will be made . insertion of two implant by the contra angle handpiece with special adaptor We connect magnetic attachment(dome) on complete denture by pick up procedure at day of implant installation. Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks. Patient satisfaction measure
    Intervention Type
    Procedure
    Intervention Name(s)
    flat magnetic attachment
    Intervention Description
    All patients will receive complete denture before implant installation . The CBCT examination should be take patients received infiltration local anesthesia. A crestal incision is made using No. 15 c blade Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant by the contra angle handpiece with special adaptor We connect magnetic attachment(flat) on complete denture by pick up procedure at day of implant installation. Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks. Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire
    Primary Outcome Measure Information:
    Title
    name of measurement: Patient satisfaction
    Description
    Denture satisfaction questionnaire
    Time Frame
    Patient satisfaction measure in 2 weak
    Title
    name of measurement: Patient satisfaction
    Description
    Denture satisfaction questionnaire
    Time Frame
    Patient satisfaction measure in 12 weak
    Secondary Outcome Measure Information:
    Title
    name of measurement: implant stability
    Description
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe.
    Time Frame
    Implant stability will be measure at day of implant
    Title
    name of measurement: implant stability
    Description
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe.
    Time Frame
    Implant stability will be measure after 2 weak
    Title
    name of measurement: implant stability
    Description
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
    Time Frame
    Implant stability will be measure after 4 weak
    Title
    name of measurement: implant stability
    Description
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
    Time Frame
    Implant stability will be measure after 8 weak
    Title
    name of measurement: implant stability
    Description
    Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
    Time Frame
    Implant stability will be measure after 12 weak

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: completely edentulous patient. Age range from 40 to 70 year old Skeletal class 1 Both sexes. Exclusion Criteria: No intra oral soft and hard tissue pathology Heavy smokers more than 20 cigarettes per day. Patients with systemic disease that may affect normal healing. Patient with sever parafunctional occlusal activity. Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability,.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hussein H moalla, bachelor
    Phone
    02201021422480
    Email
    husein_hatam@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    runnd s zwain, bachelor
    Phone
    01101034909

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    8555143
    Citation
    Boerrigter EM, Geertman ME, Van Oort RP, Bouma J, Raghoebar GM, van Waas MA, van't Hof MA, Boering G, Kalk W. Patient satisfaction with implant-retained mandibular overdentures. A comparison with new complete dentures not retained by implants--a multicentre randomized clinical trial. Br J Oral Maxillofac Surg. 1995 Oct;33(5):282-8. doi: 10.1016/0266-4356(95)90038-1.
    Results Reference
    background
    PubMed Identifier
    11208203
    Citation
    Allen PF, McMillan AS, Walshaw D. A patient-based assessment of implant-stabilized and conventional complete dentures. J Prosthet Dent. 2001 Feb;85(2):141-7. doi: 10.1067/mpr.2001.113214.
    Results Reference
    background
    PubMed Identifier
    12182304
    Citation
    Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Montreal, Quebec, May 24-25, 2002. Int J Oral Maxillofac Implants. 2002 Jul-Aug;17(4):601-2. No abstract available.
    Results Reference
    background
    PubMed Identifier
    4500507
    Citation
    Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. J Prosthet Dent. 1972 Feb;27(2):120-32. doi: 10.1016/0022-3913(72)90188-6. No abstract available.
    Results Reference
    background
    PubMed Identifier
    19553853
    Citation
    Barao VA, Assuncao WG, Tabata LF, Delben JA, Gomes EA, de Sousa EA, Rocha EP. Finite element analysis to compare complete denture and implant-retained overdentures with different attachment systems. J Craniofac Surg. 2009 Jul;20(4):1066-71. doi: 10.1097/SCS.0b013e3181abb395.
    Results Reference
    background

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    Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment

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