- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05476419
Apical Gap Length and Adaptation of Zirconia Post Using Intraoral and Extraoral Scan of Silicon Impression Technique
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rv Mh El-boghdady, Ass lecturer
- Phone Number: 01007172887
- Email: rivan.elboghdady@dentistry.cu.edu.eg
Study Contact Backup
- Name: Ri Ma El-boghdady, Ass lecturer
- Phone Number: 01007172887
- Email: pinkparadise20@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
-
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Rv Ma El-boghdady, Ass lecturer
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Theme 3 (FPD3-3-8)RM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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