Dimethyl SulfoxideNCT06635382
Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique
A study testing Universal single bond adhesive and DMSO in people with Dimethyl Sulfoxide, run by Manipal University College Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dimethyl Sulfoxide
- What is being tested?
- Universal single bond adhesive and DMSO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2024to 1 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique: A Randomized Controlled Trial
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.
- Conditions
- Dimethyl Sulfoxide
- Being tested
- Universal single bond adhesive, DMSO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal single bond adhesiveOther
Will be applied and light cured for 20 seconds.
DMSOOther
DMSO application on tooth followed by active application of universal single bond adhesive and light cured for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Universal single bond adhesive | Active comparator | Not described Receives: Other: Universal single bond adhesive |
| DMSO application before Universal single bond adhesive | Experimental | Not described Receives: Other: Universal single bond adhesive; Other: DMSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: From treatment to 3-6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dimethyl SulfoxideStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manipal University College Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Pradeep, Melaka Manipal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635382
- Sponsor's protocol ID
- 049/2023
- Status last verified
- Oct 2024
- First submitted
- 2 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24558525Hickel 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.
PubMed 36504246
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06635382
- Acronym / sponsor ID
- 049/2023
- Conditions
- Dimethyl Sulfoxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Manipal University College MalaysiaUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal single bond adhesive | Active comparator | Other: Universal single bond adhesive |
| DMSO application before Universal single bond adhesive | Experimental | Other: Universal single bond adhesive, Other: DMSO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Universal single bond adhesiveWill be applied and light cured for 20 seconds. | Other | DMSO application before Universal single bond adhesive, Universal single bond adhesive |
| DMSODMSO application on tooth followed by active application of universal single bond adhesive and light cured for 20 seconds. | Other | DMSO application before Universal single bond adhesive |
Primary outcome
Fracture of material
Time frame: From treatment to 3-6 months follow up
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)
Marginal adaptation
Time frame: From treatment to 3-6 months follow up
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Results publication: PubMed 24558525Lopez-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.
- Results publication: PubMed 36504246Hickel 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Universal single bond adhesive and DMSO in people with Dimethyl Sulfoxide, run by Manipal University College Malaysia.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anchu Rachel Thomas (1-700-811-662, rachel.thomas@manipal.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture of material (time frame: From treatment to 3-6 months follow up). 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?
On the ClinicalTrials.gov record for NCT06635382, which also lists 2 linked publications.
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 10 Oct 2024.