Evaluation of Marginal, Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano Hybrid and Lithium Di-silicate Ceramic Materials.

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04737005
Collaborator
(none)
28
2
12.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crown
N/A

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
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Nano-ceramic hybrid (Grandio Blocs) Endo-crown.

Nano-ceramic hybrid ( intervention)

Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crown
Nano-ceramic hybrid

Active Comparator: Lithium di-silicate Ceramic (E.max CAD blocks) Endo-crown

Lithium di-silicate Ceramic ( Control)

Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crown
Nano-ceramic hybrid

Outcome Measures

Primary Outcome Measures

  1. Marginal and internal gap evaluation [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 Outcome Measures

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

    Clinical performance will be measured by modified USPHS criteria and the measuring unit by Alpha (A), Bravo (B) and Charlie (C)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mai Salahel-din Abdel-azim, principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT04737005
Other Study ID Numbers:
  • 191020
First Posted:
Feb 3, 2021
Last Update Posted:
Feb 3, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 3, 2021