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

Dental Wear Clinical Trial

Official title:

Evaluation of Wear Behavior of Onlay Restorations Constructed From Two Types of Glass Ceramics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431465
• Other study ID #: Wear of Vita Ambria
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 2023

Study information

• Verified date: March 2023
• Source: Al-Azhar University
• Contact: Abdelaziz HE Abdelaziz, M.D.Sc.
• Phone: 002 (01005494627)
• Email: abdelazizelhamarawy.209[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carious Tooth
• Dental Caries
• Dental Wear
• Tooth Wear

Intervention

Other:
• Vita Ambria
onlay restoration will be fabricated from Zirconia reinforced lithium disilicate glass ceramic(vita ambria)
• IPs emax onaly
onlay restoration will be fabricated from lithium disilicate glass ceramic(IPS emax)

Locations

Country	Name	City	State
Egypt	Faculty of Dental Medicine , Al Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year follow up
Secondary	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.	1 year follow up
Secondary	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	1 year follow up