Marginal Evaluation of Zirconia Reinforced Lithium Disilicate Partial Coverage Restoration of Egyptian Posterior Teeth.

NCT05281861 | Active Not Recruiting

• 1 other identifier: V.Ambria Adaptation(679/272)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the marginal adaptation of the zirconia reinforced lithium disilicate (VITA AMBRIA) glass ceramic Inlay/Onlay compared with lithium disilicate(IPS emax Press) glass ceramic Inlay/Onlay in decayed posterior teeth.

Conditions

Carious Teeth; Adaptation

Keywords

Inlay, Onlay, Partial coverage,

Outcome Measures

Primary Outcomes (1)

• Marginal Adaptation

  Measuring device: visual and probe. According to FDI standard(Grade 1-5), which has been defined as follows: Grade 1. Harmonious outline, no gaps, no white or discolored lines. Grade 2. Marginal gap (\> 50 μm and \< 150 μm), white lines; small marginal fracture removable by polishing; slight ditching, slight step /flashes, minor irregularities Grade 3. Gap (\> 150 μm and \< 250 μm) not removable; several small marginal fractures; major irregularities, ditching or flash, steps. Grade 4. Gap (\> 250 μm) dentine/base exposed, chip fracture damaging margins, Notable enamel, or dentine wall fracture. Grade 5. Restoration is loose but in situ.

  1 year follow up

Secondary Outcomes (3)

• Restoration Fracture and retention

  1 year follow up

• Effect of the restoration on the periodontium

  1 year follow up

• Tooth cracks and fractures

  1 year follow up

Study Arms (2)

Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration

EXPERIMENTAL

The onlays will be constructed from Zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic system

Other: Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration

Lithium disilicate (IPS e-max press) ceramic onlay restoration

ACTIVE COMPARATOR

The onlays will be constructed from Lithium disilicate (IPS e-max press) glass ceramic system

Other: Lithium disilicate (IPS e-max press) ceramic onlay restoration

Interventions

Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration OTHER

In experimental group, Participants will be restored with onlay ceramic restorations constructed from zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic

Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration

Lithium disilicate (IPS e-max press) ceramic onlay restoration OTHER

In control group, Participants will be restored with onlay ceramic restorations constructed from Lithium disilicate (IPS e-max press) glass ceramic

Lithium disilicate (IPS e-max press) ceramic onlay restoration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The patient is healthy.
• years old.
• Normal occlusion.
• Good oral hygiene.
• Tooth with complete root apex.
• Tooth with moderate coronal decay.

You may not qualify if:

• Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University (Cairo)

Cairo, Egypt

Location

Related Publications (3)

• Falahchai M, Babaee Hemmati Y, Neshandar Asli H, Neshandar Asli M. Marginal adaptation of zirconia-reinforced lithium silicate overlays with different preparation designs. J Esthet Restor Dent. 2020 Dec;32(8):823-830. doi: 10.1111/jerd.12642. Epub 2020 Aug 18.

  PMID: 32810388 BACKGROUND

• Guess PC, Vagkopoulou T, Zhang Y, Wolkewitz M, Strub JR. Marginal and internal fit of heat pressed versus CAD/CAM fabricated all-ceramic onlays after exposure to thermo-mechanical fatigue. J Dent. 2014 Feb;42(2):199-209. doi: 10.1016/j.jdent.2013.10.002. Epub 2013 Oct 24.

  PMID: 24161516 BACKGROUND

• Bastos NA, Bitencourt SB, Carneiro RF, Ferrairo BM, Strelhow SSF, Dos Santos DM, Bombonatti JFS. Marginal and internal adaptation of lithium disilicate partial restorations: A systematic review and meta-analysis. J Indian Prosthodont Soc. 2020 Oct-Dec;20(4):338-344. doi: 10.4103/jips.jips_112_20. Epub 2020 Oct 8.

  PMID: 33487960 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

lithia disilicate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohamed FA Metwally, BDS

  Lecturer of Crown and Bridge Faculty of Dental Medicine, Al-Azhar University

  STUDY DIRECTOR

• . Khaled MO Haggag, Professor

  Professor of Crown and Bridge Faculty of Dental Medicine, Al-Azhar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded (Patient and outcome assessors)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Department of Crown and Bridge, Al-Azhar University

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: April 1, 2022
• Primary Completion: October 1, 2023
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

EG (1)