Clinical trial NCT05281861: Marginal Evaluation of Zirconia Reinforced Lithium Disilicate Partial Coverage Restoration of Egyptian Posterior Teeth.
Official title: Evaluation of Marginal Adaptation of Onlay Restorations Constructed From Two Types of Glass Ceramics: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carious Teeth
Adaptation
Keywords: Inlay, Onlay, Partial coverage,
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 50
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: Objective: To evaluate the marginal adaptation of the zirconia reinforced lithium disilicate (VITA AMBRIA) glass ceramic Inlay/Onlay compared with lithium disilicate(IPS emax Press) glass ceramic Inlay/Onlay in decayed posterior teeth.

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 will be evaluated by a blind and calibrated two examiner using the FDI (World Dental Federation) criteria. A total of 25 subject will be randomly assigned to each group for a total of 50 subject. 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 Inlay/Onlay preparation . Digital impression will be taken, wax pattern for the Inlay/Onlay restoration will be designed and milled using CAD/CAM(computer-aided design/computer-aided manufacturing) software. After that, the wax pattern will be invested and final Inlay/Onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions.

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: Marginal Adaptation
timeFrame: 1 year follow up
Secondary outcomes:
measure: Restoration Fracture and retention
timeFrame: 1 year follow up
measure: Effect of the restoration on the periodontium
timeFrame: 1 year follow up
measure: Tooth cracks and fractures
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University (Cairo)
Study officials:
affiliation: Lecturer of Crown and Bridge Faculty of Dental Medicine, Al-Azhar University
name: Mohamed FA Metwally, BDS
role: STUDY_DIRECTOR
affiliation: Professor of Crown and Bridge Faculty of Dental Medicine, Al-Azhar University
name: . Khaled MO Haggag, Professor
role: STUDY_CHAIR
References:
citation: Falahchai M, Babaee Hemmati Y, Neshandar Asli H, Neshandar Asli M. Marginal adaptation of zirconia-reinforced lithium silicate overlays with different preparation designs. J Esthet Restor Dent. 2020 Dec;32(8):823-830. doi: 10.1111/jerd.12642. Epub 2020 Aug 18.
citation: Guess PC, Vagkopoulou T, Zhang Y, Wolkewitz M, Strub JR. Marginal and internal fit of heat pressed versus CAD/CAM fabricated all-ceramic onlays after exposure to thermo-mechanical fatigue. J Dent. 2014 Feb;42(2):199-209. doi: 10.1016/j.jdent.2013.10.002. Epub 2013 Oct 24.
citation: Bastos NA, Bitencourt SB, Carneiro RF, Ferrairo BM, Strelhow SSF, Dos Santos DM, Bombonatti JFS. Marginal and internal adaptation of lithium disilicate partial restorations: A systematic review and meta-analysis. J Indian Prosthodont Soc. 2020 Oct-Dec;20(4):338-344. doi: 10.4103/jips.jips_112_20. Epub 2020 Oct 8.