Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment

What Was Tested

This registered not phased trial tested DMSO (dimethyl sulfoxide, non-peptide solvent).

It had two arms (groups): 3M single bond, etch and rinse adhesive (active comparator) and DMSO pre-treatment before 3M single bond application (experimental).

The registry classes the interventions as other.

More on the Plan

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.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 16 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with cervical lesions. 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.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: bruxism and visible wear facets in the posterior dentition; known inability to return for recall appointments; fractured or visibly cracked candidate tooth.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got DMSO (dimethyl sulfoxide, non-peptide solvent) and who got the comparison, which limits bias.

The DMSO (dimethyl sulfoxide, non-peptide solvent) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on DMSO (dimethyl sulfoxide, non-peptide solvent), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2020-11-17 with completion listed for 2022-12-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Biological (change of caries adjacent to the restoration) (time frame: Day 0, Month 6, Month 12, Month 18).

It also tracked 1 secondary outcome, for example Functional (change of marginal adaptation).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the DMSO (dimethyl sulfoxide, non-peptide solvent) compound page, all human trials.