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Apical Gap Length and Adaptation of Zirconia Post Using Intraoral and Extraoral Scan of Silicon Impression Technique

Primary Purpose

Endodontically Treated Teeth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Direct intra-oral scanning technique for the post space.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Endodontically Treated Teeth

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 16-65 years with endodontically treated anterior tooth or teeth & in need of custom made post and core restoration.
  2. Be physically and psychologically able to tolerate conventional restorative procedures.
  3. Subject tooth free of clinical symptoms & No requirement for endodontic retreatment expressed by the presence of periapical radiolucency around an endodontically treated tooth.
  4. Adequate level of oral hygiene expressed by the absence of signs of periodontal inflammation, bleeding on probing and periodontal pocket depth <4 mm.
  5. Capable of signing an informed consent

Exclusion Criteria:

  1. Advanced periodontitis affecting the mobility of the teeth (mobility grade II or higher)
  2. Pregnant or lactating females. 3. Patients with Psychiatric problems or unrealistic expectations.

4- Patients with endodontically treated teeth which is not functioning or showing any signs or symptoms that need endodontic retreatment.

5- Occlusion problems. 6- Absence of posterior stopper.

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Direct intra-oral scanning technique for the post space.

    In-direct scanning of the conventional post space silicone impression.

    Arm Description

    intervention will be the direct scanning of the prepared post space inside the patient mouth by using an intraoral scanner.

    The comparator will be extraoral scanning of the conventional sillicon impression of the prepared post space by using an extraoral scanner.

    Outcomes

    Primary Outcome Measures

    Apical gap length
    measuring apical gap length by the digital Periapical radiograph using the paralleling technique.

    Secondary Outcome Measures

    Post adaptation
    Measuring post adaptation by using Replica technique

    Full Information

    First Posted
    July 23, 2022
    Last Updated
    February 7, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05476419
    Brief Title
    Apical Gap Length and Adaptation of Zirconia Post Using Intraoral and Extraoral Scan of Silicon Impression Technique
    Official Title
    Evaluation of Apical Gap Length and Adaptation of Custom Made Zirconia Post Using Digital Intraoral and Extraoral Scan of Conventional Silicon Impression Technique. (Randomized Controlled Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    December 2024 (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

    5. Study Description

    Brief Summary
    First, participants will undergo clinical and radiographic examination for taking all the needed preoperative records, then endodontically treated teeth preparation starting with removal of any carious or undermined tooth structure then ferrule preparation then followed by intra-radicular preparation and then placement of the provisional restoration. In the third visit we will take the final impression of the post space for each patient by using the intraoral scan and extraoral scan o f the conventional impression. Then assessment of the apical gap length by using digital periapical radiograph using the paralleling technique and assessment of post adaptation using replica technique followed by placement and permanent cementation of the zirconia custom made post and core restoration that showed less apical gap length and better adaptation then taking the final impression for the extracoronal restoration and finally permanent cementation of the extra coronal fixed restoration.
    Detailed Description
    Examination and diagnosis:Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done. Primary impression will be taken to produce study cast. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily. Taking a professional pre-operative photo. Tooth preparation procedure: Removal of any carious or undermined tooth structure then coronal preparation will be done with a ferrule of at least 1.5 to 2 mm then followed by root canal preparation to an adequate length and diameter. After tooth preparation, the final impression will be taken for the post space for each participant by using the intraoral scan and extraoral scan of the conventional silicone impression. Fabrication of temporary restoration using composite resin temporary material and cemented using Zinc Oxide eugenol free temporary cement. Fabrication of restoration: Monolithic zirconia will be used for the fabrication of post and core restoration. Assessment of the apical gap length by using digital periapical radiograph using the paralleling technique. Assessment of post adaptation using replica technique followed by placement and permanent cementation of the zirconia custom made post and core restoration that showed less apical gap length and better adaptation. Taking the final impression for the extracoronal restoration. Finally permanent cementation of the extra coronal fixed restoration.

    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
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    11 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Direct intra-oral scanning technique for the post space.
    Arm Type
    Experimental
    Arm Description
    intervention will be the direct scanning of the prepared post space inside the patient mouth by using an intraoral scanner.
    Arm Title
    In-direct scanning of the conventional post space silicone impression.
    Arm Type
    Active Comparator
    Arm Description
    The comparator will be extraoral scanning of the conventional sillicon impression of the prepared post space by using an extraoral scanner.
    Intervention Type
    Other
    Intervention Name(s)
    Direct intra-oral scanning technique for the post space.
    Intervention Description
    scanning of prepared dental post space directly inside the patient mouth by using an intra-oral scanner
    Primary Outcome Measure Information:
    Title
    Apical gap length
    Description
    measuring apical gap length by the digital Periapical radiograph using the paralleling technique.
    Time Frame
    through study completion, an average of 1 year".
    Secondary Outcome Measure Information:
    Title
    Post adaptation
    Description
    Measuring post adaptation by using Replica technique
    Time Frame
    through study completion, an average of 1 year".

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 16-65 years with endodontically treated anterior tooth or teeth & in need of custom made post and core restoration. Be physically and psychologically able to tolerate conventional restorative procedures. Subject tooth free of clinical symptoms & No requirement for endodontic retreatment expressed by the presence of periapical radiolucency around an endodontically treated tooth. Adequate level of oral hygiene expressed by the absence of signs of periodontal inflammation, bleeding on probing and periodontal pocket depth <4 mm. Capable of signing an informed consent Exclusion Criteria: Advanced periodontitis affecting the mobility of the teeth (mobility grade II or higher) Pregnant or lactating females. 3. Patients with Psychiatric problems or unrealistic expectations. 4- Patients with endodontically treated teeth which is not functioning or showing any signs or symptoms that need endodontic retreatment. 5- Occlusion problems. 6- Absence of posterior stopper. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rv Mh El-boghdady, Ass lecturer
    Phone
    01007172887
    Email
    rivan.elboghdady@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ri Ma El-boghdady, Ass lecturer
    Phone
    01007172887
    Email
    pinkparadise20@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rv Ma El-boghdady, Ass lecturer
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Apical Gap Length and Adaptation of Zirconia Post Using Intraoral and Extraoral Scan of Silicon Impression Technique

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