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Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla

Primary Purpose

Missing Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
slopped shoulder implant
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Tooth

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Good oral hygiene
  • Systemically healthy (free from any systemic diseases).
  • Adequate native bone to achieve implant primary stability
  • Have had the tooth extraction at least 3 months before implant surgery.
  • Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery

Exclusion Criteria:

  • Smokers
  • Pregnant woman
  • Had a history of alcoholism or drug abuse within the past 5 years.
  • Had bruxism or clenching habits.
  • Patients who refused to join the study.
  • Had significant untreated periodontal disease or history of treated periodontitis.
  • Had caries on teeth adjacent to the prospective implant site.
  • Periapical infection.
  • localized radiation therapy of the oral cavity; antitumor chemotherapy.
  • poor oral hygiene

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    slopped shoulder implant

    conventional implant with flat platform

    Arm Description

    The osteotomy site will be prepared using appropriate drill sizes with flapless approach, The implant (conventional neck implant design )will be inserted till the platform will be flushed with the crestal bone, The primary stability will be checked using torque wrench

    inserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform). The primary stability will be checked using torque wrench

    Outcomes

    Primary Outcome Measures

    pink esthetic score(PES)
    soft tissue esthetics scale : Seven variables will be evaluated vs. a natural reference tooth: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14.

    Secondary Outcome Measures

    crestal bone resorption
    bone loss around implant neck will be measured using (CBCT) cone beam computed tomography. On CBCT scans, the amount of bone resorption in the buccal, lingual/palatal, mesial and distal surfaces will be determined by measuring the distance from the platform of the implant to the alveolar crest (normal group: 0-1.5mm, mild bone loss: 1.6-3mm, moderate bone loss: 3.1-4.5mm and severe bone loss: >4.5mm)
    implant stability
    osteointegration of dental implant using (periotest device ).Periotest value range: 8.0 to0.0 Good osseointegration 0.1 to +9.9 the implant can be loaded 10.0 or higher loading of the implant might or might not be possible

    Full Information

    First Posted
    July 16, 2018
    Last Updated
    July 30, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03614442
    Brief Title
    Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla
    Official Title
    Evaluation of the Effect of Slopped Shoulder Implant Neck Versus Conventional Implant Neck Design on the Crestal Bone Level in the Maxilla: Randomized Clinical Trial (RCT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 30, 2018 (Anticipated)
    Primary Completion Date
    September 1, 2018 (Anticipated)
    Study Completion Date
    September 1, 2018 (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
    In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching.The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues.
    Detailed Description
    Implant prosthesis allows normal muscle function, and the implant stimulates the bone and maintains its dimensions in a manner similar to healthy natural teeth. Crestal bone loss can result in increased bacterial accumulation resulting in secondary peri-implant inflammation and bone loss which can further result in loss of alveolar support, which in turn can lead to occlusal overload resulting in implant failure. In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching. The authors developed the concept of slopped shoulder implant which results in an inward bone creeping at the coronal part of the implant to be in continuity with the alveolar bone crest. The rational to use this type of implant allows an increase at residual crestal bone volume around the implant neck and has 3 merits: Reduced mechanical stress at the implant neck area; Repositioning of gingival papillae on the beveled neck implant (that is the physiologic condition); proper vascular supply to the implant investing structure and bone tissue also because of reduced inter-implant space. The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Missing Tooth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    the design of the dental implant
    Allocation
    Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    slopped shoulder implant
    Arm Type
    Experimental
    Arm Description
    The osteotomy site will be prepared using appropriate drill sizes with flapless approach, The implant (conventional neck implant design )will be inserted till the platform will be flushed with the crestal bone, The primary stability will be checked using torque wrench
    Arm Title
    conventional implant with flat platform
    Arm Type
    Active Comparator
    Arm Description
    inserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform). The primary stability will be checked using torque wrench
    Intervention Type
    Other
    Intervention Name(s)
    slopped shoulder implant
    Intervention Description
    different implant design to enhance soft and hard tissue outcome
    Primary Outcome Measure Information:
    Title
    pink esthetic score(PES)
    Description
    soft tissue esthetics scale : Seven variables will be evaluated vs. a natural reference tooth: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14.
    Time Frame
    8 months
    Secondary Outcome Measure Information:
    Title
    crestal bone resorption
    Description
    bone loss around implant neck will be measured using (CBCT) cone beam computed tomography. On CBCT scans, the amount of bone resorption in the buccal, lingual/palatal, mesial and distal surfaces will be determined by measuring the distance from the platform of the implant to the alveolar crest (normal group: 0-1.5mm, mild bone loss: 1.6-3mm, moderate bone loss: 3.1-4.5mm and severe bone loss: >4.5mm)
    Time Frame
    8 months
    Title
    implant stability
    Description
    osteointegration of dental implant using (periotest device ).Periotest value range: 8.0 to0.0 Good osseointegration 0.1 to +9.9 the implant can be loaded 10.0 or higher loading of the implant might or might not be possible
    Time Frame
    8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Good oral hygiene Systemically healthy (free from any systemic diseases). Adequate native bone to achieve implant primary stability Have had the tooth extraction at least 3 months before implant surgery. Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery Exclusion Criteria: Smokers Pregnant woman Had a history of alcoholism or drug abuse within the past 5 years. Had bruxism or clenching habits. Patients who refused to join the study. Had significant untreated periodontal disease or history of treated periodontitis. Had caries on teeth adjacent to the prospective implant site. Periapical infection. localized radiation therapy of the oral cavity; antitumor chemotherapy. poor oral hygiene

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla

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