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New dental liner aims to ease Post-Filling tooth pain

NCT ID NCT07261137

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new dental liner called Vitrebond™ Pulp Protect Liner/Base, placed under fillings to reduce tooth sensitivity after treating decay. It included 5 people aged 7 and older with moderate to advanced tooth decay. The liner was compared to a similar existing product, and participants reported their sensitivity levels over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vitrebond™ Pulp Protect Liner/Base (dental liner)
What this could lead to
If it works, this could provide a new option for dentists to reduce tooth sensitivity after filling cavities.
What could go wrong
This was a very small study (only 5 people) that was terminated early, so results are limited and may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5 people

The number who actually took part.

Started

Feb 2026

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is 7 years of age or older at time of consent. 2. Subject or Subject's Legally Authorized Representative is able to understand and willing to sign an Informed Consent Form or give Assent, as applicable. 3. Subject is able and willing to attend all scheduled study visits. 4. Subject is able and willing to follow study restrictions. 5. Subject is in good general health (i.e., meets ASA Level I or ASA Level II classification criteria). 6. 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. 7. Subject has existing dental radiographic images of acceptable diagnostic quality taken within 1 month of tooth restoration. 8. 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. 9. Study tooth has a positive response to a sensibility test (i.e., cold test using a refrigerant spray). 10. Study tooth has no pre-operative sensitivity or exhibit pre-operative sensitivity that is relieved immediately after stimulus removal. 11. Study tooth can be restored with a direct permanent restoration (stepwise caries removal will not be used). 12. Study tooth involving multiple carious surfaces can be restored with a single, continuous restoration (excluding buccal and lingual surfaces). Exclusion Criteria: 1. Subject has a history of adverse reaction to any materials used in this study, including but not limited to acrylates. 2. 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. 3. 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. 4. 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. 5. Subject is pregnant or breast feeding at the time of screening. 6. Subject has any spontaneous or other orofacial pain (including toothache, percussion tenderness, and periapical radiolucency). 7. 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). 8. Subject has Temporal Mandibular Disorder with pain. 9. Study tooth with current or previous trauma or previous restorations. 10. Study tooth diagnosed with cracked tooth syndrome. 11. Study tooth with mobility \>= grade 2 using the Miller's tooth mobility index. 12. 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. 13. Tooth surface loss (attrition, erosion, abrasion or abfraction) on study tooth or adjacent teeth that could impact perception of pain. 14. Study tooth has no systemic mineralization pathology (e.g., amelogenesis imperfecta, enamel hypoplasia, etc). 15. 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: 16. Study tooth with pulp exposure under any circumstance (caries exposure, mechanical/traumatic).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Tufts University

    Boston, Massachusetts, 02111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.