Adaptation Clinical Trial
Official title:
Evaluation of Marginal Adaptation of Onlay Restorations Constructed From Two Types of Glass Ceramics: A Randomized Clinical Trial
Verified date | January 2024 |
Source | Al-Azhar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Al-Azhar University (Cairo) | Cairo |
Lead Sponsor | Collaborator |
---|---|
Al-Azhar University |
Egypt,
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
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 |
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