Caries, DentalNCT07261137
Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations
A study testing Vitrebond™ Pulp Protect Liner/Base and Vitrebond™ Plus (comparator) in people with Caries, Dental and Tooth Decay, run by Solventum US LLC at 1 site in United States.
Trial summary
This is a clinical study evaluating a new dental product called Solventum™ Vitrebond™ Pulp Protect Liner/Base. This new product is designed to be used as a liner or base between the tooth and the dental filling, as well as for a procedure called direct pulp capping (DPC) if there is exposed pulp. Read more about this study
- Who is it for?
- Ages 7 to 89 years
- Conditions the study is for
- Caries, Dental, Tooth Decay, Dental Decay
- What is being tested?
- Vitrebond™ Pulp Protect Liner/Base and Vitrebond™ Plus (comparator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to 15 Apr 2026
- 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 7 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is 7 years of age or older at time of consent.
- Subject or Subject's Legally Authorized Representative is able to understand and willing to sign an Informed Consent Form or give Assent, as applicable.
- Subject is able and willing to attend all scheduled study visits.
- Subject is able and willing to follow study restrictions.
- Subject is in good general health (i.e., meets ASA Level I or ASA Level II classification criteria).
- Subject has at least 1 permanent tooth with moderate or advanced (per ICDAS Guidelines/ADA caries classification system) occlusal and/or proximal caries based upon clinical and/or radiographic evaluation.
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- Subject has existing dental radiographic images of acceptable diagnostic quality taken within 1 month of tooth restoration.
- Study tooth has healthy periodontal tissues or mildly inflamed tissues, with probing depths no greater than 4 mm and no gingival recession associated with self-reported sensitivity.
- Study tooth has a positive response to a sensibility test (i.e., cold test using a refrigerant spray).
- Study tooth has no pre-operative sensitivity or exhibit pre-operative sensitivity that is relieved immediately after stimulus removal.
- Study tooth can be restored with a direct permanent restoration (stepwise caries removal will not be used).
- Study tooth involving multiple carious surfaces can be restored with a single, continuous restoration (excluding buccal and lingual surfaces).
Who cannot join
- Subject has a history of adverse reaction to any materials used in this study, including but not limited to acrylates.
- Subject is unable, for any reason, to tolerate the study procedures or the length of time required to complete the restoration(s) on the study tooth.
- Subject is taking part in or planning to be enrolled in a clinical evaluation of any other dental materials at any time during the study.
- Subject has a history of chronic use of anti-inflammatory, analgesic (pain), and/or mind-altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter perception of pain.
- Subject is pregnant or breast feeding at the time of screening.
- Subject has any spontaneous or other orofacial pain (including toothache, percussion tenderness, and periapical radiolucency).
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- Subject has caries or conditions involving non-study teeth that may interfere with the sensitivity assessments (e.g., advanced caries in a non-study tooth in the same quadrant as the study tooth).
- Subject has Temporal Mandibular Disorder with pain.
- Study tooth with current or previous trauma or previous restorations.
- Study tooth diagnosed with cracked tooth syndrome.
- Study tooth with mobility >= grade 2 using the Miller's tooth mobility index.
- Study tooth has previous and/or current signs or symptoms of pulpal and/or periapical disease (e.g., root resorption or pulpal calcifications) or irreversible pulpitis.
- Tooth surface loss (attrition, erosion, abrasion or abfraction) on study tooth or adjacent teeth that could impact perception of pain.
- Study tooth has no systemic mineralization pathology (e.g., amelogenesis imperfecta, enamel hypoplasia, etc).
- Subject is, in the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria.
- Intra-Operative Exclusion Criteria:
- Study tooth with pulp exposure under any circumstance (caries exposure, mechanical/traumatic).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Clinical Study Evaluating the Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations
This is a clinical study evaluating a new dental product called Solventum™ Vitrebond™ Pulp Protect Liner/Base. This new product is designed to be used as a liner or base between the tooth and the dental filling, as well as for a procedure called direct pulp capping (DPC) if there is exposed pulp. Dental pulp is the part of the tooth that contains the nerves, blood vessels, and cells that keep your tooth healthy. This study will focus specifically on the liner/base application.
In this study, the Solventum study product will be compared to a similar, commercially available product made by Solventum called 3M™ Vitrebond™ Plus Light Cure Glass Ionomer Liner/Base (Vitrebond Plus for short). The study will include participants who are at least 7 years old who have at least one tooth with moderate or advanced caries (tooth decay).
The entire duration of the study is anticipated to be 2 years from when the first subject begins the study until the last subject completes the study. The duration of each study subject's participation will be up to 1 year consisting of an initial tooth restoration visit at baseline, a subject self-reported post-operative sensitivity assessment at 1 week reported by phone call, and in-person follow-up assessments at 1 month, 6 months, and 1 year post-restoration to confirm safety and effectiveness. The study will be partially blinded, which means that the participant and the dentist doing the assessments won't know which liner/base product is used on their tooth.
Read the detailed description
This is a single-site, randomized, controlled, partially blinded, non-inferiority, parallel-group study comparing two liner/base materials: Solventum™ Vitrebond™ Pulp Protect Liner/Base and 3M™ Vitrebond™ Plus. Both products will be used as intended in accordance with their cleared labeling. Restorations on study teeth will be performed in accordance with the relevant manufacturer's Instructions for Use and the clinical investigation plan.
Enough Subjects will be enrolled and confirmed eligible to treat 128 teeth with either Vitrebond Pulp Protect or Vitrebond Plus (64 per treatment arm) as the liner/base. A single eligible tooth with moderate or advanced occlusal and/or proximal caries per subject may be included in the study. Randomization will be stratified by caries depth as determined during screening such that there will be a targeted 1:1 ratio of the two treatment arms allocated for each stratum. There will be no minimum size requirement for enrollment by caries depth.
Intra-oral photographs will be taken of the prepared tooth on the day of restoration just prior to and just after lining/basing the cavity floor. Standard dental radiographs (x-rays) will be taken at baseline for the screening purposes to determine tooth eligibility.
Tooth sensitivity assessments will be self-reported by subjects. All other assessments will be performed by dental examiners who are independent of the dentist who performed the restoration procedure and are blinded to treatment.
- Conditions
- Caries, Dental, Tooth Decay, Dental Decay, Tooth Sensitivity
- Being tested
- Vitrebond™ Pulp Protect Liner/Base, Vitrebond™ Plus (comparator)
- Keywords
- dental, caries, liner-base, tooth sensitivity, Vitrebond Pulp Protect, Vitrebond Plus, pulp vitality
- Medical subject headings
- Dental Caries, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrebond™ Pulp Protect Liner/BaseDevice
Vitrebond™ Pulp Protect Liner/Base used as a liner / base during restoration of permanent teeth with moderate or advanced occlusal and/or proximal caries.
Vitrebond™ Plus (comparator)Device
Vitrebond™ Plus used as a liner / base during restoration of permanent teeth with moderate or advanced occlusal and/or proximal caries.
| Study group | Role | What they receive |
|---|---|---|
| Vitrebond™ Pulp Protect Liner/Base | Experimental | Study tooth will be treated with Vitrebond™ Pulp Protect Liner/Base as a liner/base. Receives: Device: Vitrebond™ Pulp Protect Liner/Base |
| Vitrebond™ Plus | Active comparator | Study tooth will be treated with Vitrebond™ Plus (comparator) as a liner/base. Receives: Device: Vitrebond™ Plus (comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-reported post-operative sensitivity at 1 week
Tooth sensitivity will be self-reported by subjects prior to tooth restoration to establish baseline, and post-operatively at 1 week post-restoration. Categories for pre/post-operative sensitivity will be graded on the following scale:
- Absence of pain/sensitivity
- Mild to moderate pain/sensitivity
- Severe / Spontaneous pain
Spontaneous pain is defined as prolonged intense pain that doesn't respond to pain medication, and/or pain that wakes you up from sleep.
Measured: 1 week
Secondary outcomes (2)
Pulp Vitality
Pulp vitality assessed by pulp sensibility testing response to cold stimuli (i.e., endo ice). Pulp sensibility testing will be administered at baseline (pre-restoration), 1 month, 6 months, and 1 year post-procedure using a refrigerant spray intended for dental use. A positive response from the pulp sensibility test at the timepoints described is indicative of the pulp vitality of the tooth. A lower score is desired.
Categories for pulp vitality will include:
- Vital pulp (normal): Positive response from the pulp sensibility test that subsides within 5 seconds.
- Reversible pulpitis: Positive response from pulp sensibility test that lasts greater than 5 seconds up to 30 seconds.
- Irreversible pulpitis: Prolonged positive response from pulp sensibility test that lasts more than 30 seconds.
- Non-vital pulp: Negative response from the pulp sensibility test.
Measured: assessed at baseline, 1 month, 6 months, and 1 year after tooth restoration
Patient self-reported post-operative sensitivity at 1 month
Tooth sensitivity will be self-reported by subjects prior to tooth restoration to establish baseline, and post-operatively at 1 month post-restoration. Categories for pre/post-operative sensitivity will be graded on the following scale:
- Absence of pain/sensitivity
- Mild to moderate pain/sensitivity
- Severe / Spontaneous pain
Spontaneous pain is defined as prolonged intense pain that doesn't respond to pain medication, and/or pain that wakes you up from sleep.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start17 Feb 2026
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Why it stopped: The study was terminated early due to a business decision by the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies 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
- Model description
- randomized, controlled, partially blinded, clinical study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mabi Singh, DMD, BDS, MS, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261137
- Sponsor's protocol ID
- EM-11-050090
- Status last verified
- May 2026
- First submitted
- 21 Nov 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Study Evaluating the Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations
- ClinicalTrials.gov ID
- NCT07261137
- Acronym / sponsor ID
- EM-11-050090
- Conditions
- Caries, Dental, Tooth Decay, Dental Decay, Tooth Sensitivity
- Keywords
- dental, caries, liner-base, tooth sensitivity, Vitrebond Pulp Protect, Vitrebond Plus, pulp vitality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to a business decision by the sponsor.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 3 Dec 2025 (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 is a clinical study evaluating a new dental product called Solventum™ Vitrebond™ Pulp Protect Liner/Base. This new product is designed to be used as a liner or base between the tooth and the dental filling, as well as for a procedure called direct pulp capping (DPC) if there is exposed pulp. Dental pulp is the part of the tooth that contains the nerves, blood vessels, and cells that keep your tooth healthy. This study will focus specifically on the liner/base application.
In this study, the Solventum study product will be compared to a similar, commercially available product made by Solventum called 3M™ Vitrebond™ Plus Light Cure Glass Ionomer Liner/Base (Vitrebond Plus for short). The study will include participants who are at least 7 years old who have at least one tooth with moderate or advanced caries (tooth decay).
The entire duration of the study is anticipated to be 2 years from when the first subject begins the study until the last subject completes the study. The duration of each study subject's participation will be up to 1 year consisting of an initial tooth restoration visit at baseline, a subject self-reported post-operative sensitivity assessment at 1 week reported by phone call, and in-person follow-up assessments at 1 month, 6 months, and 1 year post-restoration to confirm safety and effectiveness. The study will be partially blinded, which means that the participant and the dentist doing the assessments won't know which liner/base product is used on their tooth.
Detailed description
This is a single-site, randomized, controlled, partially blinded, non-inferiority, parallel-group study comparing two liner/base materials: Solventum™ Vitrebond™ Pulp Protect Liner/Base and 3M™ Vitrebond™ Plus. Both products will be used as intended in accordance with their cleared labeling. Restorations on study teeth will be performed in accordance with the relevant manufacturer's Instructions for Use and the clinical investigation plan.
Enough Subjects will be enrolled and confirmed eligible to treat 128 teeth with either Vitrebond Pulp Protect or Vitrebond Plus (64 per treatment arm) as the liner/base. A single eligible tooth with moderate or advanced occlusal and/or proximal caries per subject may be included in the study. Randomization will be stratified by caries depth as determined during screening such that there will be a targeted 1:1 ratio of the two treatment arms allocated for each stratum. There will be no minimum size requirement for enrollment by caries depth.
Intra-oral photographs will be taken of the prepared tooth on the day of restoration just prior to and just after lining/basing the cavity floor. Standard dental radiographs (x-rays) will be taken at baseline for the screening purposes to determine tooth eligibility.
Tooth sensitivity assessments will be self-reported by subjects. All other assessments will be performed by dental examiners who are independent of the dentist who performed the restoration procedure and are blinded to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, controlled, partially blinded, clinical study
| Arm | Type | Receives |
|---|---|---|
| Vitrebond™ Pulp Protect Liner/Base | Experimental | Device: Vitrebond™ Pulp Protect Liner/BaseStudy tooth will be treated with Vitrebond™ Pulp Protect Liner/Base as a liner/base. |
| Vitrebond™ Plus | Active comparator | Device: Vitrebond™ Plus (comparator)Study tooth will be treated with Vitrebond™ Plus (comparator) as a liner/base. |
Who may qualify
- Ages
- 7 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is 7 years of age or older at time of consent.
- Subject or Subject's Legally Authorized Representative is able to understand and willing to sign an Informed Consent Form or give Assent, as applicable.
- Subject is able and willing to attend all scheduled study visits.
- Subject is able and willing to follow study restrictions.
- Subject is in good general health (i.e., meets ASA Level I or ASA Level II classification criteria).
Key exclusion criteria (17 listed)
- Subject has a history of adverse reaction to any materials used in this study, including but not limited to acrylates.
- Subject is unable, for any reason, to tolerate the study procedures or the length of time required to complete the restoration(s) on the study tooth.
- Subject is taking part in or planning to be enrolled in a clinical evaluation of any other dental materials at any time during the study.
- Subject has a history of chronic use of anti-inflammatory, analgesic (pain), and/or mind-altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter perception of pain.
- Subject is pregnant or breast feeding at the time of screening.
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 |
|---|---|---|
| Vitrebond™ Pulp Protect Liner/BaseVitrebond™ Pulp Protect Liner/Base used as a liner / base during restoration of permanent teeth with moderate or advanced occlusal and/or proximal caries. | Device | Vitrebond™ Pulp Protect Liner/Base |
| Vitrebond™ Plus (comparator)Vitrebond™ Plus used as a liner / base during restoration of permanent teeth with moderate or advanced occlusal and/or proximal caries. | Device | Vitrebond™ Plus |
Primary outcome
Patient self-reported post-operative sensitivity at 1 week
Time frame: 1 week
Tooth sensitivity will be self-reported by subjects prior to tooth restoration to establish baseline, and post-operatively at 1 week post-restoration. Categories for pre/post-operative sensitivity will be graded on the following scale: 1. Absence of pain/sensitivity 2. Mild to moderate pain/sensitivity 3. Severe / Spontaneous pain Spontaneous pain is defined as prolonged intense pain that doesn't respond to pain medication, and/or pain that wakes you up from sleep.
2 secondary outcomes
Pulp Vitality
Time frame: assessed at baseline, 1 month, 6 months, and 1 year after tooth restoration
Patient self-reported post-operative sensitivity at 1 month
Time frame: 1 month
Results and safety
The study was stopped early (reason given: The study was terminated early due to a business decision by the sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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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.
Mabi Singh, DMD, BDS, MS principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrebond™ Pulp Protect Liner/Base and Vitrebond™ Plus (comparator) in people with Caries, Dental and Tooth Decay, run by Solventum US LLC at 1 site in United States.
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 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 6 May 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 United States. 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 was stopped early (reason given: The study was terminated early due to a business decision by the sponsor.). Results are not available in the source record.
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?
Patient self-reported post-operative sensitivity at 1 week (time frame: 1 week). 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 6 May 2026.