NCT06635382

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

October 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

September 2, 2024

Last Update Submit

October 8, 2024

Conditions

Dimethyl Sulfoxide

Outcome Measures

Primary Outcomes (2)

  • Fracture of material

    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)

    From treatment to 3-6 months follow up

  • Marginal adaptation

    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)

    From treatment to 3-6 months follow up

Study Arms (2)

Universal single bond adhesive

ACTIVE COMPARATOR
Other: Universal single bond adhesive

DMSO application before Universal single bond adhesive

EXPERIMENTAL
Other: Universal single bond adhesiveOther: DMSO

Interventions

Universal single bond adhesiveOTHER

Will be applied and light cured for 20 seconds.

DMSO application before Universal single bond adhesiveUniversal single bond adhesive
DMSOOTHER

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

DMSO application before Universal single bond adhesive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Lopez-Frias FJ, Castellanos-Cosano L, Martin-Gonzalez J, Llamas-Carreras JM, Segura-Egea JJ. Clinical measurement of tooth wear: Tooth wear indices. J Clin Exp Dent. 2012 Feb 1;4(1):e48-53. doi: 10.4317/jced.50592. eCollection 2012 Feb.

    PMID: 24558525RESULT

  • Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.

    PMID: 36504246RESULT

MeSH Terms

Interventions

Dimethyl Sulfoxide

Intervention Hierarchy (Ancestors)

SulfoxidesSulfur CompoundsOrganic Chemicals

Central Study Contacts

Anchu Rachel Thomas

CONTACT

1-700-811-662rachel.thomas@manipal.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2024

First Posted

October 10, 2024

Study Start

October 20, 2024

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

October 10, 2024

Record last verified: 2024-10