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Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases. (dentistry)

Primary Purpose

Missing Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tub shaped design
Inlay shaped design
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

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • From 18-55 years old, should be able to read and sign the consent document.
  • Ability to tolerate the restorative procedures (physical and psychological).
  • Good oral hygiene
  • Low susceptibility to decay
  • Have a minimum coronal tooth height of 5 mm,
  • Parallel abutments
  • Sufficient mesio distal edentulous gap dimensions.

Exclusion Criteria:

  • Partially erupted teeth (young)
  • Bad oral hygiene and motivation
  • Root canal treated teeth
  • Psychiatric problems or unrealistic expectations
  • Severe para-functional habits
  • The absence of enamel on the preparation margins
  • Extensive crown defects
  • Abutment mobility

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tub shaped design

    Inlay shaped design

    Arm Description

    The tub-shaped preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.

    The occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars.

    Outcomes

    Primary Outcome Measures

    Fracture
    Fracture assessed by modified Ryge Criteria ( Alpha , Bravo , Charlie and Delta )

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2018
    Last Updated
    October 19, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03715842
    Brief Title
    Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases.
    Acronym
    dentistry
    Official Title
    Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 11, 2019 (Anticipated)
    Primary Completion Date
    March 11, 2020 (Anticipated)
    Study Completion Date
    April 11, 2020 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The interest in partial coverage retainers such as inlays and onlays have increased drastically because these restorations are able to provide a more conservative option requiring minimal tissue removal thus preserving healthy tooth structure to a maximum extent. If patient rejects an implant treatment and enough sound tooth structure is available it would be desirable to restore a missing tooth with Inlay-Retained Fixed Partial Denture instead of full coverage retained one . The use of all-ceramic materials for inlays and onlays in restorative dentistry is becoming more popular , the proper selection of restorative materials, careful preparation design and adequate adhesion between tooth/restorative material interfaces considered important factor to prevent failures . Zirconia was introduced into dentistry in the 1990s.The high initial strength and fracture toughness of zirconia results from a physical property of partially stabilized zirconia known as transformation toughening. On the other hand, its white color, similar to the color of natural teeth and its ability to transmit light makes it useful in aesthetically important areas . Inlay Fixed Partial Denture restoration may have increased the risk of fracture due to the relative small size of restorations compared to the complete coverage restoration. An unfavorable distribution of stresses between the ceramic inlay and tooth structure may result in marginal deterioration around the inlay or its failure. The direction of forces on the occlusal surface of Inlay Fixed Partial Denture may lead to the phenomenon of submargination, ceramic fracture, wear at interface and postoperative hypersensitivity which remain a problem that require further investigation. One of the most important factors in the success and longevity of a restoration is to have an accurate marginal fit. Ideally, the cemented restoration should precisely meet the finish line of the prepared tooth. In reality, clinical perfection is challenging to achieve and to verify.
    Detailed Description
    The tub-shaped inlay preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished. Participant timeline The visits will be designated as follows: Visit 1: one week after allocation, preoperative records, face-to-face adherence reminder session, clinical examination, radiographic examination, intraoral photography and primary impressions for diagnostic cast construction . Visit 2: one week after the first visit, teeth preparations, secondary impression and temporization . Visit 3: one week after the second visit, try in for the restoration will be done. Visit 4: one week after the try in, final cementation of the restoration.(GC resin cement) Visit 5: follow up after twelve months from the cementation visit. The aim of the study is to assess the fracture resistance of two inlay retained bridge designs (tub shaped and inlay shaped) in missing posterior teeth cases. Based on previous papers by Ohlmann et al., 2008 7 and İzgi et al.,2011 4 indicate that the failure rate among controls is 52%. If the true failure rate for experimental subjects is 99%, we will need to study 12 in each group to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use an uncorrected chi-squared statistic to evaluate this null hypothesis. This number is to be increased to 15 in each group (25% more than the calculated) to compensate for possible losses during follow up. The sample size was calculated by PS: Power and Sample Size Calculation software Version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA).

    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
    Participant
    Allocation
    Randomized
    Enrollment
    7 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tub shaped design
    Arm Type
    Experimental
    Arm Description
    The tub-shaped preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.
    Arm Title
    Inlay shaped design
    Arm Type
    Active Comparator
    Arm Description
    The occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars.
    Intervention Type
    Other
    Intervention Name(s)
    Tub shaped design
    Intervention Description
    The tub-shaped inlay preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.
    Intervention Type
    Other
    Intervention Name(s)
    Inlay shaped design
    Intervention Description
    The occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars.
    Primary Outcome Measure Information:
    Title
    Fracture
    Description
    Fracture assessed by modified Ryge Criteria ( Alpha , Bravo , Charlie and Delta )
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: From 18-55 years old, should be able to read and sign the consent document. Ability to tolerate the restorative procedures (physical and psychological). Good oral hygiene Low susceptibility to decay Have a minimum coronal tooth height of 5 mm, Parallel abutments Sufficient mesio distal edentulous gap dimensions. Exclusion Criteria: Partially erupted teeth (young) Bad oral hygiene and motivation Root canal treated teeth Psychiatric problems or unrealistic expectations Severe para-functional habits The absence of enamel on the preparation margins Extensive crown defects Abutment mobility

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22821429
    Citation
    Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
    Results Reference
    background
    Citation
    Shillingburg, H.T., Hobo, S. and Whitsett, L. (1997) Fundamentals of fixed prosthodontics. 3rd Edition, Quintessence, Chicago, 119-137, 171-174.
    Results Reference
    background

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    Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases.

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