NCT05476419

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

July 23, 2022

Last Update Submit

February 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Apical gap length

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

    through study completion, an average of 1 year".

Secondary Outcomes (1)

  • Post adaptation

    through study completion, an average of 1 year".

Study Arms (2)

Direct intra-oral scanning technique for the post space.

EXPERIMENTAL

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

Other: Direct intra-oral scanning technique for the post space.

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

ACTIVE COMPARATOR

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

Other: Direct intra-oral scanning technique for the post space.

Interventions

scanning of prepared dental post space directly inside the patient mouth by using an intra-oral scanner

Direct intra-oral scanning technique for the post space.In-direct scanning of the conventional post space silicone impression.

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Patients with endodontically treated teeth which is not functioning or showing any signs or symptoms that need endodontic retreatment.
  • Occlusion problems. 6- Absence of posterior stopper.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Rv Ma El-boghdady, Ass lecturer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rv Mh El-boghdady, Ass lecturer

CONTACT

Ri Ma El-boghdady, Ass lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 23, 2022

First Posted

July 27, 2022

Study Start

September 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 1, 2024

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share