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Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate

Primary Purpose

Endodontically Treated Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reinforced lithium silicate endocrowns
Post retained reinforced lith silicate crn
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth

Eligibility Criteria

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

Inclusion Criteria:

  • • Patient age range of 18-55 years.

    • Patients physically and psychologically able to tolerate conventional restorative procedures.
    • Co-operative patients approving to participate in this trial.
    • Patients with root canal treated lower first molars requiring full coverage restoration.
    • Patients willing to return for follow-up examinations and assessments.
    • Endodontically treated teeth with absence of clinical diagnosis of periapical pathosis, fistula, swelling of periodontal tissues, abnormal tooth mobility and history of sensitivity to pressure

Exclusion Criteria:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with poor oral hygiene.
  • Disabilities which will not be cooperative patient for the study.
  • Systemic diseases or severe medically compromised patients as uncontrolled diabetes or oral cancer.
  • Patients suffer from parafunctional habits
  • Teeth with fractured roots
  • Teeth with lesions extending apical to the cemento-enamel junction
  • Poor oral hygiene.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Reinforced lithium silicate endocrown

    Reinforced lithi silicate crn e post

    Arm Description

    Device: Endocrown restoration

    Device: Post retained reinforced lithium silicate crowns

    Outcomes

    Primary Outcome Measures

    Recurrent caries
    It will be assessed using United States public health service (USPHS) criteria.

    Secondary Outcome Measures

    Patient satisfaction
    Questionnaire regarding patient satisfaction will be evaluated by the assessor
    Retention
    retention of the two groups will be assessed using the modified United States public health service (USPHS) criteria (Alpha,Bravo,Charlie)

    Full Information

    First Posted
    October 16, 2018
    Last Updated
    October 26, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03713918
    Brief Title
    Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate
    Official Title
    Clinical Assessment of Retention, Patient Satisfaction and Recurrent Caries of Endocrowns Versus Post Retained Crowns Using Reinforced Lithium Silicate.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 15, 2018 (Anticipated)
    Primary Completion Date
    October 30, 2019 (Anticipated)
    Study Completion Date
    November 30, 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
    No

    5. Study Description

    Brief Summary
    Coronal retention of the restoration of RCT teeth is usually compromised, thus intraradicular posts combined or not with core material may be required. The drawbacks of the conventional treatment created a necessary demand to have alternative treatment options. Among these options is the endocrown restoration. The pulpal chamber cavity provides retention and stability. Its trapezoidal shape in mandibular molars and triangular shape in maxillary molars increase the restoration's stability. The saddle form of the pulpal floor increases stability. This anatomy, along with the adhesive qualities of the bonding material, make no need for additional preparation or further use of post-involving root canals.
    Detailed Description
    Aim of the study: The aim of this study is to evaluate the effect of using reinforced lithium silicate endocrowns on the recurrent caries, patient satisfaction and retention in comparison to post retained reinforced lithium silicate crowns. The study is held to evaluate recurrent caries,patient satisfaction and retention of endodontically treated teeth restored with Endocrowns versus Post Retained Crowns using Reinforced Lithium Silicate after one year follow up . The clinical performance of ceramic endocrowns showed a survival rate of 99 % and the success rate of 89.9 % in a 10 year retrospective study done by Bellflamme et al. 2017. Endocrowns; a recently developed line of treatment, take the advantage of the rapidly growing discipline of adhesion to glass ceramics. As the retention and recurrent caries are decisive factors in the prognosis of a restoration' they have to be thoroughly investigated. Patients with endodontically treated lower first molars will be collected.after teeth preparation to receive endocrowns and crowns ,secondary impressions will be taken .The Patients will be divided randomly into two groups .One group will receive reinforced Lithium Silicate Endocrowns (intervention)and the other group will receive reinforced Lithium Silicate Crowns (control) retained with fiber posts.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endodontically Treated Teeth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients requiring posterior single crowns or endocrowns
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Participants and outcome assessor will be blinded to avoid performance, detection and analysis bias. Only main investigator will be aware of the allocated patients in each group and the specific type of intervention given to every patient
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Reinforced lithium silicate endocrown
    Arm Type
    Experimental
    Arm Description
    Device: Endocrown restoration
    Arm Title
    Reinforced lithi silicate crn e post
    Arm Type
    Active Comparator
    Arm Description
    Device: Post retained reinforced lithium silicate crowns
    Intervention Type
    Other
    Intervention Name(s)
    Reinforced lithium silicate endocrowns
    Other Intervention Name(s)
    endocrowns
    Intervention Description
    The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with reinforced lithium silicate and cemented with self adhesive cement
    Intervention Type
    Other
    Intervention Name(s)
    Post retained reinforced lith silicate crn
    Intervention Description
    The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and reinforced lithium silicate crown will be cemented with self adhesive cement.
    Primary Outcome Measure Information:
    Title
    Recurrent caries
    Description
    It will be assessed using United States public health service (USPHS) criteria.
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    Questionnaire regarding patient satisfaction will be evaluated by the assessor
    Time Frame
    one year
    Title
    Retention
    Description
    retention of the two groups will be assessed using the modified United States public health service (USPHS) criteria (Alpha,Bravo,Charlie)
    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: • Patient age range of 18-55 years. Patients physically and psychologically able to tolerate conventional restorative procedures. Co-operative patients approving to participate in this trial. Patients with root canal treated lower first molars requiring full coverage restoration. Patients willing to return for follow-up examinations and assessments. Endodontically treated teeth with absence of clinical diagnosis of periapical pathosis, fistula, swelling of periodontal tissues, abnormal tooth mobility and history of sensitivity to pressure Exclusion Criteria: Patients in the growth stage with partially erupted teeth. Patients with poor oral hygiene. Disabilities which will not be cooperative patient for the study. Systemic diseases or severe medically compromised patients as uncontrolled diabetes or oral cancer. Patients suffer from parafunctional habits Teeth with fractured roots Teeth with lesions extending apical to the cemento-enamel junction Poor oral hygiene.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate

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