Impact of Dentin Pretreatment With Dimethyl Sulfoxide on Behavior of Resin Composite Restorations in Non-Carious Cervical Lesions

NCT07830641 | Completed

• 1 other identifier: A0408023CD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this study to evaluate and compare the impact of dimethyl sulfoxide dentin surface pretreatment on the performance of composite restorations in non-cervical carious lesions

Conditions

Class V Non-carious Cervical Dental Lesions

Keywords

etch and rinse adhesives; dimethyl sulfoxide; dentine pretreatment

Outcome Measures

Primary Outcomes (2)

• 1. FDI criteria score-aesthetic properties (A1 surface luster and surface texture; A2 Marginal staining; A3 color match), Functional (F1 Fracture/Retention; F2 marginal adaptation), biological (B1 caries at restoration margin)

  1. Aesthetic properties Restorations will be evaluated for A1 (surface luster and texture), A2 (marginal staining), and A3 (color match). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. 2. Unit of Measure: FDI score Functional properties Restorations will be evaluated for F1 (fracture/retention) and F2 (marginal adaptation). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. 3. Unit of Measure: FDI score Biological properties Restoration assessment of B1 (car

  Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months

• FDI criteria score

  1\. FDI criteria score-aesthetic properties (A1 surface luster and surface texture; A2 Marginal staining; A3 color match), Functional (F1 Fracture/Retention; F2 marginal adaptation), biological (B1 caries at restoration margin) 1. Aesthetic properties Restorations will be evaluated for A1 (surface luster and texture), A2 (marginal staining), and A3 (color match). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. 2. Unit of Measure: FDI score Functional properties Restorations will be evaluated for F1 (fracture/retention) and F2 (marginal adaptation). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. 3. Biological properties Restoration assessment of B1 (caries at restoration margin)

  Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months

Study Arms (2)

etch and rinse adhesive ( 3 steps ) with 5% DMSO dentin surface pretreatment

EXPERIMENTAL

participants in this group will receive resin composite restorations using etch-and-rinse adhesive system under conventional wet-bonding conditions following pretreatment of dentin substrate with a 5% DMSO solution. after acid aching, the dentin will be maintained in a visibility moist condition and treated with 5% DMSO according to study protocol. the assigned adhesive system and resin composite material will be applied and polymerized in accordance with the standardized clinical protocol.

Other: Dimethyl sulfoxide (DMSO)

etch and rinse adhesive ( 3 steps ) without 5% DMSO dentin surface pretreatment

EXPERIMENTAL

participants in this group will receive resin composite restorations using etch-and-rinse adhesive system under conventional wet-bonding without DMSO solution treatment . after acid aching, the dentin will be maintained in a visibility moist condition . the assigned adhesive system and resin composite material will be applied and polymerized in accordance with the standardized clinical protocol.

Other: NO dimethyl sulfoxide

Interventions

Dimethyl sulfoxide (DMSO) OTHER

application of DMSO as dentin surface pretreatment prior to etch and rinse adhesive and resin composite application

etch and rinse adhesive ( 3 steps ) with 5% DMSO dentin surface pretreatment

NO dimethyl sulfoxide OTHER

no DMSO pretreatment prior to etch and rinse application and resin composite restoration

etch and rinse adhesive ( 3 steps ) without 5% DMSO dentin surface pretreatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of at least two permanent teeth with non-carious cervical lesions (NCCLs) requiring restoration. Lesions were confirmed as non-carious Class V cervical defects using the Smith and Knight Tooth Wear Index (scores 2-3) to ensure standardized dentin exposure without pulpal involvement.(3)
• The selected teeth were required to be free from mobility and exhibit normal pulpal and periapical status, confirmed by the absence of spontaneous pain, tenderness to percussion, clinical signs of pulpal necrosis, and periapical radiolucency on periapical radiographs.
• Participants were required to have at least 20 natural teeth in occlusion, with the selected teeth in functional occlusion, to ensure adequate occlusal stability, uniform distribution of masticatory forces, and standardized functional loading.
• The cavity configuration had to present an incisal margin located in enamel and a gingival margin located in dentin. To standardize the dentin-to-enamel bonding substrate, only lesions with ≤50% of the cavosurface margin in enamel were included.
• The cervical cavity margin had to be equigingival or supragingival.
• Dentin sclerosis was assessed before enrollment by visual inspection and tactile examination using a dental explorer according to the University of North Carolina (UNC) Clinical Dentin Sclerosis Scale (scores 1-4). To standardize the dentin substrate and minimize substrate-related variability, only lesions with sclerosis scores of 1 or 2 were included
• Participants had to be willing and able to comply with the study protocol and attend all scheduled follow-up visits.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Interventions

Dimethyl Sulfoxide

Intervention Hierarchy (Ancestors)

Sulfoxides; Sulfur Compounds; Organic Chemicals

Study Officials

• shimaa alaelden salem, master

  MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: December 15, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 22, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)