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Assessment Of Inlay Retained Bridge Designs In Missing Posterior Teeth Cases. (Randomized Clinical Trial)

Primary Purpose

Tooth Loss

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tub shaped inlay bridge design
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring inlay bridge, tub shaped design

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. From 18-55 years old, should be able to read and sign the consent document.
  2. Ability to tolerate the restorative procedures (physical and psychological).
  3. Patients with teeth problems indicated for inlay retained fixed partial denture:

    1. Good oral hygiene
    2. Low susceptibility to decay
    3. Have a minimum coronal tooth height of 5 mm,
    4. Parallel abutments
    5. Sufficient mesio distal edentulous gap dimensions.
  4. With no active periodontal or pulpal problems, with sound teeth or teeth with shallow restorations
  5. Willing to return for follow-up visits.

Exclusion Criteria:

  1. Partially erupted teeth (young)
  2. Bad oral hygiene and motivation
  3. Root canal treated teeth
  4. Psychiatric problems or unrealistic expectations
  5. Severe parafunctional habits
  6. The absence of enamel on the preparation margins
  7. Extensive crown defects
  8. Abutment mobility

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    inlay shaped inlay bridge design

    tub shaped inlay bridge design

    Arm Description

    The inlay shaped inlay bridge design preparation show three types of preparation, the inlay shaped, the tub shaped inlay bridge design and the proximal box shaped designs. Intracoronal preparation of the inlay retained prosthesis for the abutments (inlay shaped and tub shaped) should show the following criteria: The inlay shaped preparation should show an occlusal-proximal box preparation and to be designed with the line angles should be rounded, smooth and rounded corners, and rectangular flat floor with no beveling for the occlusal and gingival margins. The occlusal inlay preparation should have preparation depth allowed for a thickness of 2.0 mm for the material of the bridge. The occlusal reduction show 4 mm width with extension of 4 or 6 mm mesio distally for the posterior teeth.

    The tub-shaped reduction consist of an occlusal proximal inlay and prepared as the same geometry as the inlay shaped preparation, except that for the proximal box preparation which is not present in this preparation design.

    Outcomes

    Primary Outcome Measures

    Retention
    assess the loss of the restoration (debonding) the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)

    Secondary Outcome Measures

    marginal adaptation
    assess the fitting of the restoration on the underlying tooth the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)
    Caries
    assess if decay occurred on the abutment teeth the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)
    gingivitis
    assess if the gum aroung the teeth is inflamed the scale that will be used is the Gingival index scale and the measuring unit is score (discrete)
    fracture
    assess if cracks or fracture occurred to the restoration the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)

    Full Information

    First Posted
    April 30, 2017
    Last Updated
    May 3, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03139396
    Brief Title
    Assessment Of Inlay Retained Bridge Designs In Missing Posterior Teeth Cases. (Randomized Clinical Trial)
    Official Title
    Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases. (Randomized Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2017 (Anticipated)
    Primary Completion Date
    February 2019 (Anticipated)
    Study Completion Date
    April 2019 (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
    Yes

    5. Study Description

    Brief Summary
    Patients with missing back teeth can be restored with an inlay retained bridge.The inlay retained bridge designs include inlay shaped, tub shaped or proximal box shaped.In this study a clinical evaluation will be commenced to evaluate two designs the inlay shaped and the tub shaped.The hypothesis of our trial is that the new design may show longer survival rate due to less stress applied on the restoration which allow the restoration to function for longer period as the inlay shaped bridge showed clinical problems during survice.
    Detailed Description
    : This trial will be conducted on patients from the Outpatient clinic in the Fixed Prosthodontics Clinic, Faculty of Oral and Dental Medicine, Cairo University. - Adherence session will take place in the presence of the patients in the initial visit. This include that the patient will be informed by Abdelfattah M about the study steps and maintenance of oral hygiene instructions. Participants will be asked by Abdelfattah M about if they have any problems like pain. Motivation and enforcing the maintenance of oral hygiene measures by Abdelfattah M. The visits will be designated as follows: Visit 1: Preoperative records, face-to-face adherence reminder session, clinical examination, radiographic examination, intraoral photography and primary impressions (Zhermack ) for diagnostic cast construction ( Zhermack ) . Visit 2: teeth preparations, secondary impression ( Zhermack ) and temporization (Tempofit) . Visit 3: try in for the restoration. Visit 4: final cementation of the restoration.(GC resin cement) Visit 5: follow up Sample size: As there is no previously published effect size data regarding the effectiveness of the intervention or the control, an estimated sample size of 10 bridges would be used with allocation ratio of 1:1. Recruitment: The patients who show the inclusion criteria as mentioned will be selected by Abdelfattah M from the outpatient clinic of the fixed prosthodontics department - Cairo University. Screening will be carried out by Abdelfattah M for patients until the target population is reached. Methods: Assignment of interventions: Sequence generation The participant will be allocated in to two groups with 1:1 allocation ratio by using computer by Abdelfattah M. Implementation: Abdelfattah (the main researcher) will select the patients who show the listed inclusion criteria and divided them into two groups Blinding An independent examiner (not the main researches) will assess the all restorations (double blind study). Plans to promote participant retention & complete follow-up: Telephone numbers and addresses of the patients enrolled in the trial will be recorded by Abdelfattah M. All patients will be given a phone call before the next appointment for confirming to their coming. Efforts will be done to achieve proper participant retention like explaining the next procedure to the participant, elaborate to the participants the benefits gained from being enrolled in the study and use a schedule for the next visits. Data management All data will be managed electronically. Patient files will be stored in numerical order in a secured place. This will be carried out by Abdelfattah M Data analysis All Data will be collected, revised, arranged in tables and entered into the system by Abdelfattah M. Quantitative variables from normal distribution will be expressed as mean and standard deviation (SD) values. To test the significant differences between two groups student t-test will be used. Significant level will be set at P ≤ 0.05. Statistical analysis will be done using Statistical Package for Social Sciences, Version 21.0 (SPSS, IBM, Chicago, III, USA) for Windows. Data monitoring Data monitoring is the responsibility for the main supervisor (El Mahallawi O). Interim analysis will be done if harms occur. Harms Any harm or adverse events like pain or failure if happened will be recorded, documented and dealed with as recommended by Abdelfattah M. Consent Abdelfattah M will discuss all study aspects with all patients, so patients will be able to have an informed discussion with the researcher. Abdelfattah M will obtain written consent from the patients who willing to participate in the study. All consent forms will be in Arabic language Confidentiality All information related to the study will be stored in a secure place. All patients information will be stored in cabinets in areas with limited access. All data processing forms will be identified by a number to maintain participant confidentiality. Access to data Access to the data is allowed to the investigator and supervisors. The participant study information will be confidential. Ancillary care All patients will be followed up until the study period is completed. As any prosthetic treatment, post insertion adjustments will be done if necessary and the recall maintenance visits will be arranged. Dissemination policy The results of the study will be published as partial fulfillments for the doctorate degree in fixed prosthodontics. Topics from the study suggested for presentation or publication will be circulated to the authors. Data collection: Primary outcome: the retention of the restoration for both groups will be assessed using MUSPHS criteria. Secondary outcome: the marginal fit, caries, fracture and gingivitis for both groups will be assessed using the MUSPHS and gingival index.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Loss
    Keywords
    inlay bridge, tub shaped design

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    inlay shaped inlay bridge design
    Arm Type
    Active Comparator
    Arm Description
    The inlay shaped inlay bridge design preparation show three types of preparation, the inlay shaped, the tub shaped inlay bridge design and the proximal box shaped designs. Intracoronal preparation of the inlay retained prosthesis for the abutments (inlay shaped and tub shaped) should show the following criteria: The inlay shaped preparation should show an occlusal-proximal box preparation and to be designed with the line angles should be rounded, smooth and rounded corners, and rectangular flat floor with no beveling for the occlusal and gingival margins. The occlusal inlay preparation should have preparation depth allowed for a thickness of 2.0 mm for the material of the bridge. The occlusal reduction show 4 mm width with extension of 4 or 6 mm mesio distally for the posterior teeth.
    Arm Title
    tub shaped inlay bridge design
    Arm Type
    Experimental
    Arm Description
    The tub-shaped reduction consist of an occlusal proximal inlay and prepared as the same geometry as the inlay shaped preparation, except that for the proximal box preparation which is not present in this preparation design.
    Intervention Type
    Procedure
    Intervention Name(s)
    tub shaped inlay bridge design
    Other Intervention Name(s)
    tub shaped
    Intervention Description
    inlay retained bridge with tub shaped retainer on both abutments
    Primary Outcome Measure Information:
    Title
    Retention
    Description
    assess the loss of the restoration (debonding) the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    marginal adaptation
    Description
    assess the fitting of the restoration on the underlying tooth the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)
    Time Frame
    1 year
    Title
    Caries
    Description
    assess if decay occurred on the abutment teeth the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)
    Time Frame
    1 year
    Title
    gingivitis
    Description
    assess if the gum aroung the teeth is inflamed the scale that will be used is the Gingival index scale and the measuring unit is score (discrete)
    Time Frame
    1 year
    Title
    fracture
    Description
    assess if cracks or fracture occurred to the restoration the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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). Patients with teeth problems indicated for inlay retained fixed partial denture: Good oral hygiene Low susceptibility to decay Have a minimum coronal tooth height of 5 mm, Parallel abutments Sufficient mesio distal edentulous gap dimensions. With no active periodontal or pulpal problems, with sound teeth or teeth with shallow restorations Willing to return for follow-up visits. Exclusion Criteria: Partially erupted teeth (young) Bad oral hygiene and motivation Root canal treated teeth Psychiatric problems or unrealistic expectations Severe parafunctional habits The absence of enamel on the preparation margins Extensive crown defects Abutment mobility
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Mahmoud Abdelfattah, MDS
    Phone
    00201221583708
    Email
    mohamed.abdelgawad@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23534027
    Citation
    Izgi AD, Kale E, Eskimez S. A prospective cohort study on cast-metal slot-retained resin-bonded fixed dental prostheses in single missing first molar cases: results after up to 7.5 years. J Adhes Dent. 2013 Feb;15(1):73-84. doi: 10.3290/j.jad.a29010.
    Results Reference
    background
    PubMed Identifier
    18550253
    Citation
    Ohlmann B, Rammelsberg P, Schmitter M, Schwarz S, Gabbert O. All-ceramic inlay-retained fixed partial dentures: preliminary results from a clinical study. J Dent. 2008 Sep;36(9):692-6. doi: 10.1016/j.jdent.2008.04.017. Epub 2008 Jun 11.
    Results Reference
    background

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    Assessment Of Inlay Retained Bridge Designs In Missing Posterior Teeth Cases. (Randomized Clinical Trial)

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