Dental DiseasesDMSONCT05090085
Invivo Clinical Assessment of Dimethyl Sulfoxide in OT Primer Prior to Dental Adhesive
A study testing 3M Adper Single Bond2, Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) and 3m ESPE etch in people with Dental Diseases, run by University of Turku at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Dental Diseases
- What is being tested?
- 3M Adper Single Bond2, Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) and 3m ESPE etch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 24 Feb 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Dimethyl Sulfoxide in OT Primer Prior to Dental Adhesive: Randomized Controlled Trial
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.
Read the detailed description
Randomized Controlled Clinical Trial After the power analysis calculation, 74 cervical lesions will be included in this study. Half of them will be pretreated with 10% DMSO/H2O (Dimethyl Sulfoxide/Water, OT Primer, OT Dent). Control groups will be bonded with SB (Single Bond2, 3M ESPE). Cavities will be restored with nanohybrid composite restoration (Z350 XT, 3M ESPE) under rubber dam isolation. Follow-ups will be performed by double-blinded evaluators at baseline and after 6m, 12m, 24m, and 36m using the FDI criteria. Photographic documentation will be performed for all restorations.
Sample size calculation The sample size was calculated based on a previous study by Vural et al in 2020, in which success rate of resin composite cervical restorations was 73% after 36 months. By implementing a two tailed Z test for difference between two independent proportions with an alpha level of 5% and a power of 80%. The minimum sample size needed was 30 per group in order to detect a difference of 25%. Sample size was increased by 25% to compensate for possible dropouts to reach 37 teeth per group. Sample size was performed using G*Power version 3.1.9.2 for windows.
Statistical Analyses Data was analyzed using Medcalc software, version 22 for windows (MedCalc Software Ltd, Ostend, Belgium). Categorical data was described as frequency and percentage, intergroup comparisons between interventions was performed using Chi-Square test with statistical significance level set at (P ≤ 0.05), intragroup comparison within each intervention was performed using the Cochran's Q test with statistical significance level set at (P ≤ 0.0083) after Bonferroni correction. Relative risk was used to assess the clinical significance. Survival rate was analyzed using Kaplan-meier and Log-rank test. The confidence limit was set at 95% with 80% power and all tests were two tailed.
- Conditions
- Dental Diseases
- Being tested
- 3M Adper Single Bond2, Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA), 3m ESPE etch, OT Primer
- Keywords
- DMSO
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M Adper Single Bond2Other
Two-step etch and rinse dental adhesive system
Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)Other
Composite Resin
3m ESPE etchOther
32% phosphoric acid
OT PrimerOther
Also called 10% DMSO/H2O
Dimethyl Sulfoxide DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 3M Adper Single Bond2; Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA); Other: 3m ESPE etch; Other: OT Primer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Time Frame: Day 0, Month 12, Month 24, Month 36]
Secondary outcomes (2)
Esthetic (Number of Restorations with change of color match and translucency)
FDI criteria for evaluation of restorations, percentage score.
- Score: Properties
- Clinically excellent/ very good: Good color match, no difference in shade and/or translucency.
- Clinically good: Minor deviations in shade and/or translucency.
- Clinically sufficient/satisfactory: Distinct deviation but acceptable. Does not affect esthetics: 1. more opaque ,2. more translucent ,3. darker,4. brighter.
- Clinically unsatisfactory: Localized clinically deviation that can be corrected by repair: 1.Too opaque, 2.Too translucent,3. Too dark, 4.Too bright.
- Clinically poor: Unacceptable. Replacement necessary.
Measured: [Time Frame: Day 0, Month 12, Month 24, Month 36]
Biological (Number of Restorations with change of caries adjacent to the restoration)
FDI criteria for evaluation of restorations, percentage score.
- Score: Properties
- Clinically excellent/ very good: No secondary or primary caries.
- Clinically good: Small and Localized 1. Demineralization, 2. Erosion or 3. Abfraction.
- Clinically sufficient/satisfactory: Larger areas Of 1. Demineralization, 2. Erosion or 3. Abrasion/abfraction, dentine not exposed.
- Clinically unsatisfactory: Caries with Cavitation and suspected undermining caries, 2. Erosion in dentine, 3.
Abrasion/ abfraction in dentine.
- Clinically poor: Deep caries or exposed dentine that is not accessible for repair of restoration.
Measured: [Time Frame: Day 0, Month 12, Month 24, Month 36]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Horus University
- Responsible party
- Principal investigator, Omar Abdelaziz Ismail, University of Turku
- Investigators
- Arzu Tezvergil-Mutluay, Professor, Study chair, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090085
- Sponsor's protocol ID
- UTurku Clinical DMSO
- Acronym
- DMSO
- Status last verified
- Feb 2024
- First submitted
- 9 Oct 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Dimethyl Sulfoxide in OT Primer Prior to Dental Adhesive: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05090085
- Acronym / sponsor ID
- DMSO / UTurku Clinical DMSO
- Conditions
- Dental Diseases
- Keywords
- DMSO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Horus University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 22 Oct 2021 (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.
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.
Detailed description
Randomized Controlled Clinical Trial After the power analysis calculation, 74 cervical lesions will be included in this study. Half of them will be pretreated with 10% DMSO/H2O (Dimethyl Sulfoxide/Water, OT Primer, OT Dent). Control groups will be bonded with SB (Single Bond2, 3M ESPE). Cavities will be restored with nanohybrid composite restoration (Z350 XT, 3M ESPE) under rubber dam isolation. Follow-ups will be performed by double-blinded evaluators at baseline and after 6m, 12m, 24m, and 36m using the FDI criteria. Photographic documentation will be performed for all restorations.
Sample size calculation The sample size was calculated based on a previous study by Vural et al in 2020, in which success rate of resin composite cervical restorations was 73% after 36 months. By implementing a two tailed Z test for difference between two independent proportions with an alpha level of 5% and a power of 80%. The minimum sample size needed was 30 per group in order to detect a difference of 25%. Sample size was increased by 25% to compensate for possible dropouts to reach 37 teeth per group. Sample size was performed using G*Power version 3.1.9.2 for windows.
Statistical Analyses Data was analyzed using Medcalc software, version 22 for windows (MedCalc Software Ltd, Ostend, Belgium). Categorical data was described as frequency and percentage, intergroup comparisons between interventions was performed using Chi-Square test with statistical significance level set at (P ≤ 0.05), intragroup comparison within each intervention was performed using the Cochran's Q test with statistical significance level set at (P ≤ 0.0083) after Bonferroni correction. Relative risk was used to assess the clinical significance. Survival rate was analyzed using Kaplan-meier and Log-rank test. The confidence limit was set at 95% with 80% power and all tests were two tailed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3M Adper Single Bond2 | Active comparator | Other: 3M Adper Single Bond2, Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA), Other: 3m ESPE etchO.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. |
| DMSO application before 3M Adper Single Bond2, etch and rinse adhesive | Experimental | Other: 3M Adper Single Bond2, Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA), Other: 3m ESPE etch, Other: OT PrimerThe 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| 3M Adper Single Bond2Two-step etch and rinse dental adhesive system | Other | 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)Composite Resin | Other | 3M Adper Single Bond2, DMSO application before 3M Adper Single Bond2, etch and rinse adhesive |
| 3m ESPE etch32% phosphoric acid | Other | 3M Adper Single Bond2, DMSO application before 3M Adper Single Bond2, etch and rinse adhesive |
| OT PrimerAlso: 10% DMSO/H2ODimethyl Sulfoxide DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds. | Other | DMSO application before 3M Adper Single Bond2, etch and rinse adhesive |
Primary outcome
Functional (Number of Restorations with change of marginal adaptation)
Time frame: [Time Frame: Day 0, Month 12, Month 24, Month 36]
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.
2 secondary outcomes
Esthetic (Number of Restorations with change of color match and translucency)
Time frame: [Time Frame: Day 0, Month 12, Month 24, Month 36]
Biological (Number of Restorations with change of caries adjacent to the restoration)
Time frame: [Time Frame: Day 0, Month 12, Month 24, Month 36]
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 24 Apr 2025.
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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.
Arzu Tezvergil-Mutluay, Professor study chair
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M Adper Single Bond2, Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) and 3m ESPE etch in people with Dental Diseases, run by University of Turku 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 4 inclusion and 13 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 24 Apr 2025. 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?
Functional (Number of Restorations with change of marginal adaptation) (time frame: [Time Frame: Day 0, Month 12, Month 24, Month 36]). 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 24 Apr 2025.