Wear of Vita Ambria Only Restoration Compared With IPS Emax Onlay Restoration

NCT ID: NCT05431465

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-08-31

Brief Summary

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The 1ry objective will be to evaluate the amount of wear of onlays restorations made from VITA AMBRIA \& IPS e.max Press and their opposing natural teeth.

2\. The 2ry objective of the clinical trial will be to evaluate the fractures, retention, contact points, food impaction and radiographic examination of the VITA AMBRIA onlays compared with IPS e.max press onlays as defined by FDI criteria.

Detailed Description

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A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations are evaluated by a blind and calibrated two examiner using the FDI World Dental Federation criteria. A total of 24 patients will be randomly assigned to each group for a total of 48 patients. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.

Both groups will receive Onlay preparation . Digital impression by intra oral scanner will be taken, wax pattern for the onlay restoration will be designed and milled using CAD/CAM software. After that, the wax pattern will be invested and final onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions. Primary outcome: The amount of wear will be evaluated according to FDI standard.

Conditions

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Carious Tooth Dental Wear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vita Ambria onlay

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

Group Type EXPERIMENTAL

Vita Ambria

Intervention Type OTHER

onlay restoration will be fabricated from Zirconia reinforced lithium disilicate glass ceramic(vita ambria)

IPS emax onlay

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

Group Type ACTIVE_COMPARATOR

IPs emax onaly

Intervention Type OTHER

onlay restoration will be fabricated from lithium disilicate glass ceramic(IPS emax)

Interventions

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Vita Ambria

onlay restoration will be fabricated from Zirconia reinforced lithium disilicate glass ceramic(vita ambria)

Intervention Type OTHER

IPs emax onaly

onlay restoration will be fabricated from lithium disilicate glass ceramic(IPS emax)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient is healthy.
* 18-50 years old.
* Normal occlusion.
* Good oral hygiene.
* Tooth with complete root apex.
* Tooth with moderate coronal decay.

Exclusion Criteria

• 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Abd Elaziz Helmy Abd Elaziz Mahmoud Elhamrawy

Assistant lecturer, Department of Crown&Bridge,Al-Azhar Unverisity

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hussien RA Mohamed, Ph.D.Sc

Role: STUDY_DIRECTOR

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

Tamer AB Hamza, Professor

Role: STUDY_CHAIR

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

Locations

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Faculty of Dental Medicine , Al Azhar University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdelaziz HE Abdelaziz, M.D.Sc.

Role: CONTACT

002 (01005494627)

Facility Contacts

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Abdelaziz H Abdelaziz, M.D.Sc

Role: primary

002(01005494627)

References

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Griffis E, Abd Alraheam I, Boushell L, Donovan T, Fasbinder D, Sulaiman TA. Tooth-cusp preservation with lithium disilicate onlay restorations: A fatigue resistance study. J Esthet Restor Dent. 2022 Apr;34(3):512-518. doi: 10.1111/jerd.12666. Epub 2020 Oct 3.

Reference Type BACKGROUND
PMID: 33009726 (View on PubMed)

Lee JH, Myagmar G, Kwon HB, Han JS. A digital method for wear volume loss analysis using a single-scan three-dimensional dataset. J Dent Sci. 2022 Jan;17(1):638-641. doi: 10.1016/j.jds.2021.06.015. Epub 2021 Jul 4.

Reference Type BACKGROUND
PMID: 35028110 (View on PubMed)

Other Identifiers

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Wear of Vita Ambria

Identifier Type: -

Identifier Source: org_study_id

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