Clinical Trials Directory

Trials / Completed

CompletedNCT04492306

Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment

In Vivo Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment Prior to a Two-step Etch and Rinse Adhesive: Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
16 Years – 55 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERDimethyl SulfoxideDMSO \[(CH3)2SO\] is a polar aprotic solvent that dissolves both polar and non-polar compounds.
OTHER3M ESPE Single bond 2Total etch adhesive bond
OTHERFiltek Z350 XT, 3 M ESPE, St Paul, MN, USA)Composite Resin
OTHER3m ESPE etch32% phosphoric acid

Timeline

Start date
2020-11-17
Primary completion
2022-12-30
Completion
2022-12-30
First posted
2020-07-30
Last updated
2023-02-09

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04492306. Inclusion in this directory is not an endorsement.