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

Not Applicable

Recruiting

• Conditions: Dental Wear; Carious Tooth
• Interventions: Other: Vita Ambria; Other: IPs emax onaly

• Registration Number: NCT05431465
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Study Start: 2022-08-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Primary Completion: 2023-07
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vita Ambria onlay	Vita Ambria	The onlays will be constructed from Zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic system.
IPS emax onlay	IPs emax onaly	The onlays will be constructed from Lithium disilicate (IPS e-max press) glass ceramic system

Primary Outcome Measures

Name	Time	Method
Wear evaluation	1 year follow up	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.

Secondary Outcome Measures

Name	Time	Method
contact points and food impaction	1 year follow up	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	1 year follow up	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

Trial Locations

Locations (1)

Faculty of Dental Medicine , Al Azhar University; 🇪🇬 Cairo, Egypt