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

Primary Purpose

Carious Tooth, Dental Wear

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vita Ambria
IPs emax onaly
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carious Tooth

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dental Medicine , Al Azhar UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vita Ambria onlay

IPS emax onlay

Arm Description

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

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

Outcomes

Primary Outcome Measures

Wear evaluation
The amount of wear will be defined as follows: 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. The recordings that measured at base line and 12 month periods will be superimposed on each other by specific software. Mean values and standard deviations of the amount of wear for all restorations' and opposing enamel's will be statistically analyzed.

Secondary Outcome Measures

contact points and food impaction
contact points and food impaction of the onlay restoration will be evaluated according to FDI standard (Grade 1-5), which has been defined as follows: Grade 1: Normal contact point (floss or 25 µm metal blade of can be inserted but not 50 µm blade). Grade 2: Slightly too strong but no disadvantage: Grade 3: Slightly too weak, no indication of damage to tooth, gingivae or periodontal structures (50 µm metal blade can pass easily but not 100 µm). Grade 4:Too weak (100 µm metal blade can pass) and possible damage (food impaction). Repair possible. Grade 5:Too weak and/or clear damage (food impaction) and/or pain/gingivitis. Requires replacement.
Radiographic examination
Radiographic examination will be evaluated according to FDI standard (Grade 1-5), which has been defined as follows: Grade 1: No pathology, harmonious transition between restoration and tooth. Grade 2: (2.1) acceptable cement excess present ,(2.2) Positive/negative step present at margin<150 µm. Grade 3: (3.1) Marginal gap < 200 µm, (3.2)Negative steps visible < 250 µm and no adverse effects noticed,(3.3) Poor radiopacity of restorative material. Grade 4: (4.1) Marginal gap >250 µm, (4.2) Cement excess accessible but not removable,(4.3) Negative steps >250µm and repairable. Grade 5:(5.1) Secondary caries, large gaps ,(5.2) Apical pathology ,(5.3) Fracture/loss of restoration or tooth

Full Information

First Posted
June 20, 2022
Last Updated
March 7, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05431465
Brief Title
Wear of Vita Ambria Only Restoration Compared With IPS Emax Onlay Restoration
Official Title
Evaluation of Wear Behavior of Onlay Restorations Constructed From Two Types of Glass Ceramics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Tooth, Dental Wear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vita Ambria onlay
Arm Type
Experimental
Arm Description
The onlays will be constructed from Zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic system.
Arm Title
IPS emax onlay
Arm Type
Active Comparator
Arm Description
The onlays will be constructed from Lithium disilicate (IPS e-max press) glass ceramic system
Intervention Type
Other
Intervention Name(s)
Vita Ambria
Intervention Description
onlay restoration will be fabricated from Zirconia reinforced lithium disilicate glass ceramic(vita ambria)
Intervention Type
Other
Intervention Name(s)
IPs emax onaly
Intervention Description
onlay restoration will be fabricated from lithium disilicate glass ceramic(IPS emax)
Primary Outcome Measure Information:
Title
Wear evaluation
Description
The amount of wear will be defined as follows: 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. The recordings that measured at base line and 12 month periods will be superimposed on each other by specific software. Mean values and standard deviations of the amount of wear for all restorations' and opposing enamel's will be statistically analyzed.
Time Frame
1 year follow up
Secondary Outcome Measure Information:
Title
contact points and food impaction
Description
contact points and food impaction of the onlay restoration will be evaluated according to FDI standard (Grade 1-5), which has been defined as follows: Grade 1: Normal contact point (floss or 25 µm metal blade of can be inserted but not 50 µm blade). Grade 2: Slightly too strong but no disadvantage: Grade 3: Slightly too weak, no indication of damage to tooth, gingivae or periodontal structures (50 µm metal blade can pass easily but not 100 µm). Grade 4:Too weak (100 µm metal blade can pass) and possible damage (food impaction). Repair possible. Grade 5:Too weak and/or clear damage (food impaction) and/or pain/gingivitis. Requires replacement.
Time Frame
1 year follow up
Title
Radiographic examination
Description
Radiographic examination will be evaluated according to FDI standard (Grade 1-5), which has been defined as follows: Grade 1: No pathology, harmonious transition between restoration and tooth. Grade 2: (2.1) acceptable cement excess present ,(2.2) Positive/negative step present at margin<150 µm. Grade 3: (3.1) Marginal gap < 200 µm, (3.2)Negative steps visible < 250 µm and no adverse effects noticed,(3.3) Poor radiopacity of restorative material. Grade 4: (4.1) Marginal gap >250 µm, (4.2) Cement excess accessible but not removable,(4.3) Negative steps >250µm and repairable. Grade 5:(5.1) Secondary caries, large gaps ,(5.2) Apical pathology ,(5.3) Fracture/loss of restoration or tooth
Time Frame
1 year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelaziz HE Abdelaziz, M.D.Sc.
Phone
002 (01005494627)
Email
abdelazizelhamarawy.209@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hussien RA Mohamed, Ph.D.Sc
Organizational Affiliation
Assistant Professor of Crown and Bridge, Faculty of Dental Medicine, Al-Azhar University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tamer AB Hamza, Professor
Organizational Affiliation
Professor of Crown and Bridge, Faculty of Dental Medicine, Al-Azhar University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dental Medicine , Al Azhar University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelaziz H Abdelaziz, M.D.Sc
Phone
002(01005494627)

12. IPD Sharing Statement

Citations:
PubMed Identifier
33009726
Citation
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.
Results Reference
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PubMed Identifier
35028110
Citation
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.
Results Reference
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Wear of Vita Ambria Only Restoration Compared With IPS Emax Onlay Restoration

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