Marginal Evaluation of Zirconia Reinforced Lithium Disilicate Partial Coverage Restoration of Egyptian Posterior Teeth.

Adaptation Clinical Trial

Official title:

Evaluation of Marginal Adaptation of Onlay Restorations Constructed From Two Types of Glass Ceramics: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05281861
• Other study ID #: V.Ambria Adaptation(679/272)
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 1, 2027

Study information

• Verified date: January 2024
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 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

• Adaptation
• Carious Teeth
• Dental Caries

Intervention

Other:
• Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration
In experimental group, Participants will be restored with onlay ceramic restorations constructed from zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic
• Lithium disilicate (IPS e-max press) ceramic onlay restoration
In control group, Participants will be restored with onlay ceramic restorations constructed from Lithium disilicate (IPS e-max press) glass ceramic

Locations

Country	Name	City	State
Egypt	Al-Azhar University (Cairo)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Adaptation	Measuring device: visual and probe.; According to FDI standard(Grade 1-5), which has been defined as follows: Grade 1. Harmonious outline, no gaps, no white or discolored lines. Grade 2. Marginal gap (> 50 µm and < 150 µm), white lines; small marginal fracture removable by polishing; slight ditching, slight step /flashes, minor irregularities Grade 3. Gap (> 150 µm and < 250 µm) not removable; several small marginal fractures; major irregularities, ditching or flash, steps.; Grade 4. Gap (> 250 µm) dentine/base exposed, chip fracture damaging margins, Notable enamel, or dentine wall fracture.; Grade 5. Restoration is loose but in situ.	1 year follow up
Secondary	Restoration Fracture and retention	Fracture and retention of the onlay restoration will be evaluated. Measuring device: visual and probe.; According to FDI standard (Grade 1-5), which has been defined as follows: Grade 1: Restoration is present with no fractures, cracks or chipping. Grade 2:Small hairline cracks are visible. Grade 3:Several hairline cracks are present and/or limited chipping of material without damage to marginal quality or proximal contacts.; Grade 4: Fractures affect marginal quality and/or proximal contacts; bulk fractures with probable gap > 250 µm with or without partial loss of less than half the restoration.; Grade 5:Loss of restoration or bulk fracture with probable gap > 250 µm with partial loss of the restoration.	1 year follow up
Secondary	Effect of the restoration on the periodontium	inflammation will be evaluated. Measuring device: visual and probe according to; FDI standard (Grade 1-5), which has been defined as follows: Grade 1: No plaque, no inflammation of the gingival papilla. Grade 2: Minimal plaque is present, PBI equivalent to baseline. Grade 3: Difference up to one grade in severity of PBI compared to baseline and in comparison to control tooth.; Grade 4: Difference of more than one grade of PBI worsening in comparison to control tooth or increase in pocket depth > 1 mm requiring major intervention.; Grade 5: Severe/ acute gingivitis or periodontitis if related to the restoration requiring immediate replacement of the restoration.	1 year follow up
Secondary	Tooth cracks and fractures	Measuring device: visual and probe according to FDI standard (Grade 1-5) Grade 1: Complete integrity of the restored tooth. Grade 2: Minor marginal crack < 150 µm wide or a hairline crack which cannot be probed. The patient has no clinical symptoms.; Grade 3: (Grade 3.1) Marginal split in the enamel < 250 µm wide. Not possible to remove by polishing without compromising the shape of the tooth surface or damaging the tooth and is left untreated as not expected to cause further damage. (Grade 3.2)Crack < 250 µm. Patient has no or minimal discomfort.; Grade 4: (Grade 4.1) Major marginal split > 250 µm that requires repair and/or dentin or base exposed . (Grade 4.2):A 250-µm probe/explorer can be inserted into a crack Grade 5: A cusp or major tooth fracture requiring immediate replacement.	1 year follow up