Invivo Clinical Assessment of Dimethyl Sulfoxide in OT Primer Prior to Dental Adhesive

NCT05090085 | Completed DMC

• 1 other identifier: UTurku Clinical DMSO
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to assess the clinical effectiveness of 10% Dimethyl Sulfoxide in OT Primer prior to two step etch and rinse dental adhesive on the durability of composite restoration.

Conditions

Dental Diseases

Keywords

DMSO

Outcome Measures

Primary Outcomes (1)

• Functional (Number of Restorations with change of marginal adaptation)

  FDI criteria for evaluation of restorations, percentage score. * Score: Properties. * Clinically excellent/ very good: Harmonious outline, no gaps, no white or discolored lines. * Clinically good: Marginal gap (\<150 μm), White lines. Or Small marginal fracture removable by polishing. or Slight ditching, slight step/flashes, minor Irregularities. * Clinically sufficient/satisfactory: Gap \< 250 μm not removable. Or Several small marginal fractures. Or Major irregularities, ditching or flash, steps. * Clinically unsatisfactory: Gap \> 250 μm or dentine/base exposed. Or Severe ditching or marginal fractures. or Larger irregularities or steps (repair necessary). * Clinically poor: Restoration (complete or partial) is loose but in situ. Or Generalized major gaps or irregularities.

  [Time Frame: Day 0, Month 12, Month 24, Month 36]

Secondary Outcomes (2)

• Esthetic (Number of Restorations with change of color match and translucency)

  [Time Frame: Day 0, Month 12, Month 24, Month 36]

• Biological (Number of Restorations with change of caries adjacent to the restoration)

  [Time Frame: Day 0, Month 12, Month 24, Month 36]

Study Arms (2)

3M Adper Single Bond2

ACTIVE COMPARATOR

O.I. will clean the labial surface of the tooth with polishing paste and brush Roughening of the surface may be needed by the diamond point The tooth will be isolated by a rubber dam. Apply etchant for 30 s for enamel and 15 s for dentin. Rinse thoroughly with water for 15 s. blot-drying with paper tissue was carefully performed leaving the dentin surface slightly moist. Active application of 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 20 s. Light curing of all resin materials was performed using (3M Elipar Curing Light) delivering 1100 mW/cm2.

Other: 3M Adper Single Bond2; Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA); Other: 3m ESPE etch

DMSO application before 3M Adper Single Bond2, etch and rinse adhesive

EXPERIMENTAL

The same steps of the comparator group with an additional step, after dentin etching and humidity control, dentin pretreatments were performed consisting of active application of 10% DMSO/H2O (OT Primer, OT Dent) solutions on etched-dentin for 1 minute followed by 20 seconds of air drying then apply adhesive.

Other: 3M Adper Single Bond2; Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA); Other: 3m ESPE etch; Other: OT Primer

Interventions

3M Adper Single Bond2 OTHER

Two-step etch and rinse dental adhesive system

3M Adper Single Bond2; DMSO application before 3M Adper Single Bond2, etch and rinse adhesive

Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) OTHER

Composite Resin

3M Adper Single Bond2; DMSO application before 3M Adper Single Bond2, etch and rinse adhesive

3m ESPE etch OTHER

32% phosphoric acid

3M Adper Single Bond2; DMSO application before 3M Adper Single Bond2, etch and rinse adhesive

OT Primer OTHER

Dimethyl Sulfoxide DMSO \[(CH3)2SO\] is a polar aprotic solvent that dissolves both polar and non-polar compounds.

Also known as: 10% DMSO/H2O

DMSO application before 3M Adper Single Bond2, etch and rinse adhesive

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with Carious Cervical Lesions (CCL).
• Co-operative patients approved to participate in the study.
• Pulp is asymptomatic vital teeth.
• Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

You may not qualify if:

• Patients with Non-Carious Cervical Lesions (NCCL).
• Xerostomia
• 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 breast-feeding (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.

Sponsors & Collaborators

• University of Turku: lead
• Horus University: collaborator

Study Sites (1)

Horus University in Egypt

Damietta, Damietta Governorate, Egypt

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Arzu Tezvergil-Mutluay, Professor

  University of Turku

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In our clinical trial, double blinding will be performed, the participants and assessors will be blinded to the type of material used to reduce performance and ascertainment bias and also reduce biased estimates of treatment effects. The operator cannot be blinded in this trial because of the difference in the application procedures of each restorative material. Therefore, the operator (O.I.) will take care to treat the two allocation groups as equally as possible by standardizing the care of participants, frequency of follow-ups and management of complications.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, BDS, MSc, FINDOS Candidate Cariology and Restorative Dentistry. Member of the Adhesive group of Turku. Finland

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 22, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: February 24, 2025
• Last Updated: April 24, 2025

Record last verified: 2024-02

Locations

EG (1)