Class V Non-carious Cervical Dental LesionsNCT07830641
Impact of Dentin Pretreatment With Dimethyl Sulfoxide on Behavior of Resin Composite Restorations in Non-Carious Cervical Lesions
A study testing Dimethyl sulfoxide (DMSO) and NO dimethyl sulfoxide in people with Class V Non-carious Cervical Dental Lesions, run by Mansoura University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Class V Non-carious Cervical Dental Lesions
- What is being tested?
- Dimethyl sulfoxide (DMSO) and NO dimethyl sulfoxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2023to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- Caries risk was assessed using the Caries Management by Risk Assessment (CAMBRA) protocol. Participants classified as having moderate caries risk were eligible for inclusion. A limited number of high-risk participants were also accepted provided that the only high-risk criterion present was "three or more carious lesions or restorations within the previous 36 months."
- Participants had to be willing and able to comply with the study protocol and attend all scheduled follow-up visits.
- -
Who cannot join
- Participants were excluded if they presented with poor oral hygiene, chronic periodontitis, were undergoing active orthodontic treatment or periodontal surgery, or had xerostomia or were pregnant. Individuals with systemic conditions that could influence oral or periodontal health (e.g., hypertension, diabetes mellitus, malignancy, or other chronic diseases), or those receiving medications known to affect periodontal tissues or wound healing, were also excluded. In addition, participants exhibiting signs of severe parafunctional habits, including clenching or pronounced occlusal wear facets suggestive of bruxism, were not considered eligible for inclusion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Impact of Dentin Pretreatment With Dimethyl Sulfoxide on Behavior of Resin Composite Restorations in Non-Carious Cervical Lesions: 2-year Clinical and Laboratory Investigations
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
Read the detailed description
this clinical trial aimed to evaluate the effect of dimethyl sulfoxide (DMSO) pretreatment on the clinical performance of adhesive restorative procedures performed on dentin under wet-bonding conditions. the study will investigate wither DMSO pretreatment can improve the marginal adaptation and clinical performance of resin composite restorations placed in non-carious cervical lesions (NCCL) participants presenting with eligible non-carious lesions will receive adhesive restorative treatment according to the assigned experimental protocol. different adhesive approaches, including with and without DMSO pretreatment, will be compared. clinical outcomes will be evaluated at predefined follow-up periods using standardized clinical assessment criteria.
- Being tested
- Dimethyl sulfoxide (DMSO), NO dimethyl sulfoxide
- Keywords
- etch and rinse adhesives, dimethyl sulfoxide, dentine pretreatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl sulfoxide (DMSO)Other
application of DMSO as dentin surface pretreatment prior to etch and rinse adhesive and resin composite application
NO dimethyl sulfoxideOther
no DMSO pretreatment prior to etch and rinse application and resin composite restoration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: NO dimethyl sulfoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
- 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.
- 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.
- Unit of Measure: FDI score Biological properties Restoration assessment of B1 (car
Measured: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
FDI criteria score
- 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)
- 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.
- 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.
- Biological properties Restoration assessment of B1 (caries at restoration margin)
Measured: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start15 Dec 2023
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V Non-carious Cervical Dental LesionsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shimaa alaelden salem, master, Principal investigator, MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830641
- Sponsor's protocol ID
- A0408023CD
- Status last verified
- Dec 2023
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available because the study data contain potentially identifiable clinical information and there is no current plan for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dentin Pretreatment With Dimethyl Sulfoxide on Behavior of Resin Composite Restorations in Non-Carious Cervical Lesions: 2-year Clinical and Laboratory Investigations
- ClinicalTrials.gov ID
- NCT07830641
- Acronym / sponsor ID
- A0408023CD
- Keywords
- etch and rinse adhesives, dimethyl sulfoxide, dentine pretreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
this clinical trial aimed to evaluate the effect of dimethyl sulfoxide (DMSO) pretreatment on the clinical performance of adhesive restorative procedures performed on dentin under wet-bonding conditions. the study will investigate wither DMSO pretreatment can improve the marginal adaptation and clinical performance of resin composite restorations placed in non-carious cervical lesions (NCCL) participants presenting with eligible non-carious lesions will receive adhesive restorative treatment according to the assigned experimental protocol. different adhesive approaches, including with and without DMSO pretreatment, will be compared. clinical outcomes will be evaluated at predefined follow-up periods using standardized clinical assessment criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etch and rinse adhesive ( 3 steps ) with 5% DMSO dentin surface pretreatment | Experimental | Other: Dimethyl sulfoxide (DMSO)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. |
| etch and rinse adhesive ( 3 steps ) without 5% DMSO dentin surface pretreatment | Experimental | Other: NO dimethyl sulfoxideparticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyl sulfoxide (DMSO)application of DMSO as dentin surface pretreatment prior to etch and rinse adhesive and resin composite application | Other | etch and rinse adhesive ( 3 steps ) with 5% DMSO dentin surface pretreatment |
| NO dimethyl sulfoxideno DMSO pretreatment prior to etch and rinse application and resin composite restoration | Other | etch and rinse adhesive ( 3 steps ) without 5% DMSO dentin surface pretreatment |
Primary outcome
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)
Time frame: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
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
FDI criteria score
Time frame: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available because the study data contain potentially identifiable clinical information and there is no current plan for public data sharing.
Related trials for Class V Non-carious Cervical Dental Lesions
Active, not recruiting
Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.
Class V Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shimaa alaelden salem, master principal investigator
MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dimethyl sulfoxide (DMSO) and NO dimethyl sulfoxide in people with Class V Non-carious Cervical Dental Lesions, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.