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Lithium Disilicate Glass-ceramic Versus Hybrid Ceramic Superstructure Materials on Implant Stability (RCT)

Primary Purpose

Prosthesis Survival

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vita Enamic (hybrid dental ceramic)
lithium disilicate glass-ceramic
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prosthesis Survival focused on measuring implant supported restorations, IPS Emax (lithium disilicate glass-ceramic), Vita Enamic (hybrid dental ceramic), implant survival, peri-implant tissue response

Eligibility Criteria

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

Inclusion Criteria:

Patients > 18 yrs. Patients with missing teeth in the maxillary premolar region. Absence of any pathological condition in the recipient site.

Stabilization phase will be performed including:

  • Scaling
  • Debridement.
  • Elimination of all carious cavities and root canal treatment if needed.
  • Elimination of over-hanging restoration. Systemic condition of the subjects was evaluated according to dental modification of the Cornell medical index (Kerr and Millard 1966).

Patients who are cooperative, motivated, and hygiene conscious. Patients should have adequate ridge width (>5mm).

Exclusion Criteria:

Patients unable to undergo minor surgical procedure. Patients with history of drug abuse or metabolic drugs. Patients with history of psychiatric disorder. Patients with insufficient bone. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.

Patients with any systemic condition that may contraindicate implant therapy. Patients that may have any habits that may jeopardize the osseo-integration process, such as heavy smoking and alcoholism.

Patients with para-functional habits that produce overload on the implant such as bruxism and clenching.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hybrid superstructure

    Ceramic superstructure

    Arm Description

    Vita Enamic is a hybrid ceramic, consisting of composite and ceramic. The ceramic; compatible and high aesthetics while the composite; resilient material with low modulus of elasticity which will absorb stress and therefore decrease load on bone and eventually decrease crestal bone loss

    IPS Emax, is the mostly used ceramic superstructures in implant supported restorations.

    Outcomes

    Primary Outcome Measures

    Implant survival rate
    Implant stability and success could be affected by crestal bone loss, if the implant is stable therefore high survival rate

    Secondary Outcome Measures

    Crestal bone loss
    Crestal bone loss will be measured using a Cone Beam Computed tomography to measure the amount of bone resorbed from start date, and follow up for one year
    Peri-implant tissue response
    Bleeding index, probing depth and gingival index
    Patient satisfaction
    Patients will be asked to answer a questionnaire to know whether the procedure was not satisfied, accepted, or highly satisfied

    Full Information

    First Posted
    October 11, 2016
    Last Updated
    January 10, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02931903
    Brief Title
    Lithium Disilicate Glass-ceramic Versus Hybrid Ceramic Superstructure Materials on Implant Stability
    Acronym
    RCT
    Official Title
    The Effect of Lithium Disilicate Glass-ceramic (IPS Emax) Versus Hybrid Ceramic (Vita Enamic) Superstructure Materials on Implant Stability in Implant Supported Restorations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    March 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to assess the effect of the newly introduced (hybrid dental ceramic) superstructure materials, Vita Enamic versus IPS Emax on implant stability, patient satisfaction and crestal bone loss.
    Detailed Description
    This study will be conducted on patients requiring single implant replacement in the maxillary premolar area, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University. After a period of healing of 6 months, an implant abutment of accurate diameter and angulation will be placed to fit precisely into the internal hex of the fixture after removal of the cover screw. The platform matched abutment will be then secured into its final position using the abutment screw. Alginate impression will be taken and poured into dental stone. Using the impression transfers, impressions with polyvinylsiloxane are taken. After taking the impressions, the Impression transfers are removed and fixed to the implant replica. Surgeons' assistants will be asked to open the sealed envelope containing the information regarding the crown placement. The impressions will be sent to dental laboratory with the result of the sealed envelope, for preparation of the future crowns, either vita enamic crowns or Ips e max crowns.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prosthesis Survival
    Keywords
    implant supported restorations, IPS Emax (lithium disilicate glass-ceramic), Vita Enamic (hybrid dental ceramic), implant survival, peri-implant tissue response

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hybrid superstructure
    Arm Type
    Experimental
    Arm Description
    Vita Enamic is a hybrid ceramic, consisting of composite and ceramic. The ceramic; compatible and high aesthetics while the composite; resilient material with low modulus of elasticity which will absorb stress and therefore decrease load on bone and eventually decrease crestal bone loss
    Arm Title
    Ceramic superstructure
    Arm Type
    Active Comparator
    Arm Description
    IPS Emax, is the mostly used ceramic superstructures in implant supported restorations.
    Intervention Type
    Other
    Intervention Name(s)
    Vita Enamic (hybrid dental ceramic)
    Other Intervention Name(s)
    hybrid, resin nanoceramic
    Intervention Description
    Vita Enamic (hybrid dental ceramic) are provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology,
    Intervention Type
    Other
    Intervention Name(s)
    lithium disilicate glass-ceramic
    Other Intervention Name(s)
    Emax CAD, IPS Emax
    Intervention Description
    All ceramic crowns (Lithium disilicate glass ceramic) milled by Computer aided design/Computer aided manufacturer (CAD/CAM) technology
    Primary Outcome Measure Information:
    Title
    Implant survival rate
    Description
    Implant stability and success could be affected by crestal bone loss, if the implant is stable therefore high survival rate
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Crestal bone loss
    Description
    Crestal bone loss will be measured using a Cone Beam Computed tomography to measure the amount of bone resorbed from start date, and follow up for one year
    Time Frame
    12 months
    Title
    Peri-implant tissue response
    Description
    Bleeding index, probing depth and gingival index
    Time Frame
    12 months
    Title
    Patient satisfaction
    Description
    Patients will be asked to answer a questionnaire to know whether the procedure was not satisfied, accepted, or highly satisfied
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients > 18 yrs. Patients with missing teeth in the maxillary premolar region. Absence of any pathological condition in the recipient site. Stabilization phase will be performed including: Scaling Debridement. Elimination of all carious cavities and root canal treatment if needed. Elimination of over-hanging restoration. Systemic condition of the subjects was evaluated according to dental modification of the Cornell medical index (Kerr and Millard 1966). Patients who are cooperative, motivated, and hygiene conscious. Patients should have adequate ridge width (>5mm). Exclusion Criteria: Patients unable to undergo minor surgical procedure. Patients with history of drug abuse or metabolic drugs. Patients with history of psychiatric disorder. Patients with insufficient bone. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components. Patients with any systemic condition that may contraindicate implant therapy. Patients that may have any habits that may jeopardize the osseo-integration process, such as heavy smoking and alcoholism. Patients with para-functional habits that produce overload on the implant such as bruxism and clenching.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gihan El Naggar, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Lithium Disilicate Glass-ceramic Versus Hybrid Ceramic Superstructure Materials on Implant Stability

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