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Clinical Trials/NCT04737005
NCT04737005UnknownNot Applicable

Evaluation of Marginal and Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano-ceramic Hybrid and Lithium Di-silicate Ceramic Materials (A Randomized Controlled Clinical Trial)

Cairo University0 sites28 target enrollmentStarted: February 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
28
Primary Endpoint
Marginal and internal gap evaluation

Study Overview

Brief Summary

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

Detailed Description

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

Primary outcome: Marginal gap of the two groups will be measured using Silicon replica technique, Each replica will be sectioned bucco-lingually and mesio-distally into four segments named (MB, DB, ML, DL) and each segment has five reference points assigned at different positions, An overall of twenty reference points will be measured in each replica sample using a digital microscope.

Secondary outcome:

  • Internal gap of the two groups will be measured using Silicon replica technique, which will be measured by digital microscope.
  • Clinical Performance of the two groups will be evaluated using modified USPHS scoring system. (Color match, Marginal discoloration, Surface texture and Gross fracture)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • From 18-50 years old, be able to read and sign the informed consent document.
  • Have no active periodontal or pulpal diseases, have teeth with good restorations.
  • Psychologically and physically able to withstand conventional dental procedures.
  • Patients planned for a single coverage restoration in the posterior area.
  • Able to return for follow-up examinations and evaluation.
  • Patients have root apex of molar without evident damage and no root fracture.
  • Good oral hygiene habits.
  • Have a complete root canal therapy molar necessitating an Endo-crown restoration.

Exclusion Criteria

  • Patient less than 18 or more than 50 years
  • Patients with severe clenching or bruxism.
  • Patient with active resistant periodontal diseases
  • Patients with poor oral hygiene and uncooperative patients
  • Pregnant women
  • Patients in the growth stage with partially erupted teeth
  • Psychiatric problems or unrealistic expectations
  • Patients with inadequate or low quality endodontic treatment.

Outcomes

Primary Outcomes

Marginal and internal gap evaluation

Time Frame: 1 year

marginal and internal gap will be evaluated by silicon replica technique, each replica will be sectioned into four segments named (MB, DB, ML, DL) and each segment had five reference points assigned at different positions, an overall of twenty reference points will be measured in each replica sample using a digital microscope. The measuring unit by microns

Secondary Outcomes

  • clinical performance(Color match, Marginal discoloration, Surface texture and Gross fracture)(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mai Salahel-din Abdel-azim

principle investigator

Cairo University

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