NCT05431465

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

June 20, 2022

Last Update Submit

March 7, 2023

Conditions

Carious ToothDental Wear

Outcome Measures

Primary Outcomes (1)

  • Wear evaluation

    The amount of wear will be defined as follows: 1. Intra oral scanner will be used to scan the surface of the restorations and opposing natural enamel after achieving a complete dry surface by isolation. 2. The recordings that measured at base line and 12 month periods will be superimposed on each other by specific software. 3. Mean values and standard deviations of the amount of wear for all restorations' and opposing enamel's will be statistically analyzed.

    1 year follow up

Secondary Outcomes (2)

  • contact points and food impaction

    1 year follow up

  • Radiographic examination

    1 year follow up

Study Arms (2)

Vita Ambria onlay

EXPERIMENTAL

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

Other: Vita Ambria

IPS emax onlay

ACTIVE COMPARATOR

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

Other: IPs emax onaly

Interventions

Vita AmbriaOTHER

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

Vita Ambria onlay
IPs emax onalyOTHER

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

IPS emax onlay

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine , Al Azhar University

Cairo, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33009726BACKGROUND

  • 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.

    PMID: 35028110BACKGROUND

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Hussien RA Mohamed, Ph.D.Sc

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

    STUDY DIRECTOR

  • Tamer AB Hamza, Professor

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

    STUDY CHAIR

Central Study Contacts

Abdelaziz HE Abdelaziz, M.D.Sc.

CONTACT

002 (01005494627)abdelazizelhamarawy.209@azhar.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Department of Crown&Bridge,Al-Azhar Unverisity

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 24, 2022

Study Start

August 1, 2022

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

EG(1)