Adaptation, Carious Teeth
Conditions
Keywords
Inlay, Onlay, Partial coverage,
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.
Interventions
OTHERZirconia 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
OTHERLithium 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
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blinded (Patient and outcome assessors)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Adaptation | 1 year follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Restoration Fracture and retention | 1 year follow up | 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. |
| Effect of the restoration on the periodontium | 1 year follow up | 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. |
| Tooth cracks and fractures | 1 year follow up | 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. |
Countries
Egypt
Outcome results
None listed