Clinical trial NCT05431465: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Carious Tooth
Dental Wear
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Wear evaluation
timeFrame: 1 year follow up
Secondary outcomes:
measure: contact points and food impaction
timeFrame: 1 year follow up
measure: Radiographic examination
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine , Al Azhar University
Study officials:
affiliation: Assistant Professor of Crown and Bridge, Faculty of Dental Medicine, Al-Azhar University
name: Hussien RA Mohamed, Ph.D.Sc
role: STUDY_DIRECTOR
affiliation: Professor of Crown and Bridge, Faculty of Dental Medicine, Al-Azhar University
name: Tamer AB Hamza, Professor
role: STUDY_CHAIR
References:
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.
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.