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| Name | Class |
|---|---|
| University of Turku | OTHER |
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This study is conducted in order to evaluate the clinical effectiveness of 1% DMSO dentin pre-treatment on the clinical performance of etch and rinse adhesive.
Despite substantial advances in resin-dentin bonding over the past decades, reduction in bonding effectiveness of currently available dental adhesives remains a major limitation in modern adhesive dentistry. Hydrolysis of both organic and resin constituents of hybrid layer persists as impediments in dentin bonding longevity. Since bonding is directly related to the quality of the formed polymer the resin components play an important role in proper resin-dentin interaction and in the mechanical properties of the material.
In face of the limitations of most current clinically-feasible bonding protocols and inherent drawbacks of the etch-and-rinse approach an ideal resin-enveloped collagen scaffold is unlikely to be produced in a consistent manner. In dentin hybridization, adhesive infiltration is far from perfect resulting in poorly formed hybrid layers. Replacement of all 70 vol% residual water in etched-dentin with monomers is hardly achieved. For this reason, the hybrid layer may be considered as the weak link in resin-dentin bonds.
DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds. It is a polyfunctional molecule, with a highly polar S O group and two hydrophobic methyl groups, fully miscible in most solvents and monomers used in adhesive dentistry. DMSO is perhaps the best currently known penetration enhancer for medical purposes with the ability to dissociate the highly crosslinked collagen into a sparser network of apparent fibrils.
The rationale for testing a bonding resin with relatively low DMSO-content is that incorporation of high DMSO concentrations may hamper the mechanical properties of dimethacrylate bonding polymers, which in turn could compromise the bonded interface. DMSO's ability to "biomodify" collagen structure, increasing spaces between collagen microfibrils and improving dentin wettability support the improved bonding effectiveness even under dry-conditions. It is evident that this simplified use of DMSO or, to a better extent, its use as a dentin pretreatment reduced technique sensitivity of the etch-and-rinse approach concomitantly allowing water removal from the bonded interface by the proposed dry-bonding technique. Optimized bonding efficiency combined with reduced water-content during dentin hybridization could greatly contribute to clinical long-term durability.
Nevertheless, further studies are necessary to test such hypothesis. Specially that there is no clinical study support this theory yet even DMSO had taken the FDA approval many years ago as a pharmaceutical solvent and has been used in several medications. DMSO caused no or minor cytotoxic effects on the pulp tissue repair-related activity of odontoblast-like cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M single bond, etch and rinse adhesive | Active Comparator | O.I. will clean the labial surface of tooth with polishing paste and brush Roughening of the surface may be needed by diamond point The tooth will be isolated by rubber dam. Apply etchant for 30 s for enamel and 15 s for dentin. Rinse thoroughly with water for 10 s. blot-drying with paper tissue was carefully performed leaving the dentin surface slightly moist. Apply 2 to 3 consecutive coats of the adhesive for 15 s. Gently air for 5 s. Light cure for 10 s. Composite build ups (Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) were performed in increments and individually light-cured for 40 s. Light curing of all resin materials was performed using a LED device (Bluephase 20i, Ivoclare Vivadent, Schaan, Liechtenstein) delivering 1100 mW/cm2. |
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| DMSO pre-treatment before 3M single bond application | Experimental | The same steps of the comparator group with additional step, after dentin etching and humidity control, dentin pretreatments were performed consisting of active application of 1% DMSO/H2O solutions on etched-dentin followed by blot drying until paper filters no longer absorbed liquids from the bonding surface by capillarity then apply adhesive. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethyl Sulfoxide | Other | DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds. |
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| Measure | Description | Time Frame |
|---|---|---|
| Biological (change of caries adjacent to the restoration) | FDI criteria for evaluation of restorations, percentage score.
| Day 0, Month 6, Month 12, Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional (change of marginal adaptation) | FDI criteria for evaluation of restorations, percentage score.
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| Measure | Description | Time Frame |
|---|---|---|
| Esthetic (Color match and translucency) | FDI criteria for evaluation of restorations, percentage score.
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randa Hafez, Professor | Cairo U | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | 12613 | Egypt |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 1, 2023 | |
| Reset | May 17, 2024 | |
| Release | May 20, 2024 | |
| Reset | Sep 26, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 1, 2023 | May 17, 2024 | |||
| May 20, 2024 |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004121 | Dimethyl Sulfoxide |
| ID | Term |
|---|---|
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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In our clinical trial double blinding will be performed, the participants and both assessors (H.M.& N.H.) will be blinded to the type of the material used to reduce performance and ascertainment bias and also reduce biased estimates of treatment effects. The operator cannot be blinded in this trial because of the difference in the application procedures of each restorative material. Therefore, the operator (O.I.) will take care to treat the two allocation groups as equally as possible by standardizing the care of participants, frequency of follow-ups and management of complications.
|
| 3M ESPE Single bond 2 | Other | Total etch adhesive bond |
|
| Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) | Other | Composite Resin |
|
| 3m ESPE etch | Other | 32% phosphoric acid |
|
| Day 0, Month 6, Month 12, Month 18 |
| Day 0, Month 6, Month 12, Month 18 |
| Sep 26, 2024 |