Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment
NCT ID: NCT04492306
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2020-11-17
2022-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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3M single bond, etch and rinse adhesive
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.
3M ESPE Single bond 2
Total etch adhesive bond
Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)
Composite Resin
3m ESPE etch
32% phosphoric acid
DMSO pre-treatment before 3M single bond application
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.
Dimethyl Sulfoxide
DMSO \[(CH3)2SO\] is a polar aprotic solvent that dissolves both polar and non-polar compounds.
3M ESPE Single bond 2
Total etch adhesive bond
Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)
Composite Resin
3m ESPE etch
32% phosphoric acid
Interventions
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Dimethyl Sulfoxide
DMSO \[(CH3)2SO\] is a polar aprotic solvent that dissolves both polar and non-polar compounds.
3M ESPE Single bond 2
Total etch adhesive bond
Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)
Composite Resin
3m ESPE etch
32% phosphoric acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Co-operative patients approving to participate in the study.
* Pulp is asymptomatic vital teeth.
* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Exclusion Criteria
* Bruxism and visible wear facets in the posterior dentition.
* Known inability to return for recall appointments.
* Fractured or visibly cracked candidate tooth.
* Current desensitizing therapy, including desensitizing dentifrices or other over-the-counter (OTC) products.
* Long-term use of anti-inflammatory, analgesic, or psychotropic drugs.
* Pregnancy or breastfeeding (potential conflicts with recall dates.
* Allergies to ingredients of resin-based restorative materials.
* Orthodontic appliance treatment within the previous three months.
* Abutment teeth for fixed or removable prostheses.
* Teeth or supporting structures with any symptomatic pathology.
* Existing periodontal disease or periodontal surgery within the previous three months.
16 Years
55 Years
ALL
No
Sponsors
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University of Turku
OTHER
Cairo University
OTHER
Responsible Party
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Omar Abdelaziz Ismail
Assistant Lecturer of Restorative Dentistry,HUE. Member of the adhesive group of Turku.
Principal Investigators
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Randa Hafez, Professor
Role: STUDY_DIRECTOR
Cairo U
Locations
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Faculty of Dentistry, Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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DMSO Clinical Trial
Identifier Type: -
Identifier Source: org_study_id
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