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

February 7, 2023 updated by: Rivan Mahmoud Gamal Mohamed El-boghdady, Cairo University

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)

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.

Study Overview

Status

Not yet recruiting

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:

  1. 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.
  2. 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.
  3. 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.

Study Type

Interventional

Enrollment (Anticipated)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Direct intra-oral scanning technique for the post space.
intervention will be the direct scanning of the prepared post space inside the patient mouth by using an intraoral scanner.
scanning of prepared dental post space directly inside the patient mouth by using an intra-oral scanner
ACTIVE_COMPARATOR: In-direct scanning of the conventional post space silicone impression.
The comparator will be extraoral scanning of the conventional sillicon impression of the prepared post space by using an extraoral scanner.
scanning of prepared dental post space directly inside the patient mouth by using an intra-oral scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apical gap length
Time Frame: through study completion, an average of 1 year".
measuring apical gap length by the digital Periapical radiograph using the paralleling technique.
through study completion, an average of 1 year".

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post adaptation
Time Frame: through study completion, an average of 1 year".
Measuring post adaptation by using Replica technique
through study completion, an average of 1 year".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rv Ma El-boghdady, Ass lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2023

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

July 23, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (ACTUAL)

July 27, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Theme 3 (FPD3-3-8)RM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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