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
About this trial
This is an interventional other trial for Endodontically Treated Teeth
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.
-
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
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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