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Evaluation of Crestal Bone Loss Around Short Dental Implants As Affected By Two Suprastructure Materials

Primary Purpose

Bone Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vita Enamic (Hybrid dental ceramic)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients within age group of ≥ 18.
  2. There should be absence of any systemic diseases.
  3. Patients have missing simple posterior tooth
  4. Adequate interarch space.
  5. Inadequate residual bone height to place standard length implant.
  6. Patients with good oral hygiene.

Exclusion Criteria:

  1. A history that would complicate the outcome of the study, such as alcohol or drug dependency, smoking, poor health, or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontics treatment and required follow-up.
  2. Heavy smokers.
  3. Poorly controlled diabetes mellitus.
  4. Patients on radiotherapy.
  5. Patients with temporomandibular disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hybrid superstructure

    Ceramic superstructure

    Arm Description

    screw retained hybrid ceramic crowns

    screw retained lithium disilicate based ceramic crowns

    Outcomes

    Primary Outcome Measures

    Crestal Bone Loss Crestal bone loss will be measured using standardized digital periapical radiograph by paralleling technique and film holding device -measuring unit:Milimeters
    preventive

    Secondary Outcome Measures

    screw loosening of crowns screw loosening will be observed by clinical investigation -measuring unit:Binary (Yes/No)
    preventive

    Full Information

    First Posted
    August 11, 2021
    Last Updated
    June 9, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05066815
    Brief Title
    Evaluation of Crestal Bone Loss Around Short Dental Implants As Affected By Two Suprastructure Materials
    Official Title
    Evaluation of Crestal Bone Loss Around Short Dental Implants As Affected By Two Suprastructure Materials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 25, 2022 (Anticipated)
    Primary Completion Date
    December 25, 2022 (Anticipated)
    Study Completion Date
    December 1, 2023 (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
    The aim of the study is to evaluate the crestal bone loss developed around short dental implants after using screw retained Hybrid ceramic crowns when compare to screw retained Lithium Di silicate based ceramic crowns.
    Detailed Description
    This study will be conducted on patients requiring single implant replacement in the posterior regions of the mandible, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University. Examination and diagnosis: Selection and examination of the patients according to inclusion and exclusion criteria. Preoperative Cone Beam Computed Tomography (CBCT) to all patients. Primary impression will be taken to produce study cast. Taking a professional photo for the examined posterior area. Patients will be divided into two group: G1: Short implants will be restored by screw retained Hybrid ceramic crowns G2: Short implants will be restored by screw retained Lithium Di silicate based ceramic crowns Surgical procedures: Implants will be placed following standardized protocol. After 4 months the patients re-attended for placement of healing abutments for about (10-14) days and prosthesis fabrication. Data collection and post operative radio-logical assessment: -Taking standardized digital peri-apical radio-graph by paralleling technique and film holding device for follow up at 12 months after crowns loading to evaluate crestal bone loss.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Loss

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Hybrid superstructure
    Arm Type
    Experimental
    Arm Description
    screw retained hybrid ceramic crowns
    Arm Title
    Ceramic superstructure
    Arm Type
    Active Comparator
    Arm Description
    screw retained lithium disilicate based ceramic crowns
    Intervention Type
    Other
    Intervention Name(s)
    Vita Enamic (Hybrid dental ceramic)
    Other Intervention Name(s)
    Polymer Infiltrated Ceramic Network (PICN)
    Intervention Description
    Vita Enamic (Hybrid dental ceramic) is provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology.
    Primary Outcome Measure Information:
    Title
    Crestal Bone Loss Crestal bone loss will be measured using standardized digital periapical radiograph by paralleling technique and film holding device -measuring unit:Milimeters
    Description
    preventive
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    screw loosening of crowns screw loosening will be observed by clinical investigation -measuring unit:Binary (Yes/No)
    Description
    preventive
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients within age group of ≥ 18. There should be absence of any systemic diseases. Patients have missing simple posterior tooth Adequate interarch space. Inadequate residual bone height to place standard length implant. Patients with good oral hygiene. Exclusion Criteria: A history that would complicate the outcome of the study, such as alcohol or drug dependency, smoking, poor health, or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontics treatment and required follow-up. Heavy smokers. Poorly controlled diabetes mellitus. Patients on radiotherapy. Patients with temporomandibular disorders

    12. IPD Sharing Statement

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