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NCT Number: NCT06635382

Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique

Dimethyl sulfoxide (DMSO) wet bonding has shown promising results in several in vitro studies. However, there are a lack of clinical trials which prove the advantages of this technique. The aim of the study is to clinically assess the effect of DMSO wet bonding on composite restoration in non carious cervical lesions.

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Key information

Conditions

Dimethyl Sulfoxide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Two similar non carious cervical lesions (NCCLs) on the facial/labial surfaces of premolars.
  • NCCLs of score 1-3 on the Smith and Knight tooth wear index.
  • Favorable occlusion and teeth are in normal contact.

Exclusion criteria

  • NCCLs on the lingual surface.
  • Medically compromised individuals.
  • Periodontally compromised teeth.
  • Bruxism and visible wear facets in the posterior dentition.
  • Fractured or visibly cracked premolars and canines.
  • Known allergies to resin-based restorative materials.
  • Presently undergoing orthodontic treatment.
  • Abutment teeth for fixed or removable prostheses.

Treatment and study plan

Universal single bond adhesive

Other

Will be applied and light cured for 20 seconds.

DMSO

Other

DMSO application on tooth followed by active application of universal single bond adhesive and light cured for 20 seconds.

Primary outcomes

  1. Fracture of material

    Time frame: From treatment to 3-6 months follow up

    Different fracture patterns and retention failures may occur in relation to the type of restoration: cracks, chipping/ delamination, bulk fractures, or incomplete and complete loss of retention. Assessed by Visual examination and short air drying. Criteria set from Clinically excellent/very good(sufficient) (Score 1) to Clinically poor (entirely insufficient)(Score 5)

  2. Marginal adaptation

    Time frame: From treatment to 3-6 months follow up

    There are different interfaces between the dental hard tissue, restorative material, and adhesive and/or luting resin/cement layer. Each interface can degrade and potentially alter marginal adaptation. In clinical practice, it is impossible to distinguish failures between the different interfaces. Therefore, only the marginal adaptation as such can be assessed by visual examination and short air drying.

    Scores given depending upon the quality of restoration from Clinically excellent/very good (sufficient) (Score 1) to Clinically poor (entirely insufficient) (Score 5)

Study contacts

Contact information is provided by the study sponsor or research team.

Anchu Rachel Thomas

CONTACT

[email protected]

1-700-811-662

Sponsors and collaborators

Lead sponsor

Manipal University College Malaysia

Other

Registry information

Official study title

Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.