New dental goo aims to save teeth from decay and trauma
NCT ID NCT07231237
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a special dental material (Vitrebond) used to cover and protect the soft inner part of a tooth (the pulp) when it gets exposed due to deep cavities, injury, or dental work. The goal was to see if the material keeps the tooth alive and healthy for up to 5 years. The study was stopped early and only enrolled 5 people aged 7 and older.
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 Hide 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 age 7 years or older at time of consent. 2. Subject is in good general health (i.e., meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria). 3. Subject or Subject's Legally Authorized Representative is able and willing to understand and sign an Informed Consent Form or give Assent, as applicable. 4. Subject is able and willing to return in-person for all scheduled study visits. 5. Subject is able and willing to follow study restrictions. 6. Subject has existing dental radiographic images of the study teeth of current and acceptable diagnostic quality taken within 3 months of tooth restoration. 7. Study tooth has healthy periodontal tissues or mildly inflamed tissues not associated with trauma, with probing depths no greater than 4 mm and no gingival recession associated with self-reported sensitivity. 8. Study tooth has no pre-operative sensitivity or exhibit pre-operative sensitivity that is relieved immediately after stimulus removal. 9. Study tooth has a positive response to a sensibility test (i.e., cold test using a refrigerant spray). 10. Study tooth can be restored with a direct permanent restoration (stepwise caries removal will not be used). 11. Study teeth are on opposite right/left sides of the mouth (for Subjects with more than one candidate study tooth). 12. Study tooth will be restored no later than 1 month after the date of the first study tooth's restoration (for Subjects with more than one candidate study tooth). Intra-operative Inclusion Criteria: 13. Subject has one or more permanent teeth with pinpoint pulpal exposure (0.5 mm - 1.0 mm in diameter) needing direct pulp capping, excluding third molars. 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 (e.g., use of a rubber dam) or the length of time required to complete the restoration(s) on the study tooth/teeth. 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 (excluding pain from trauma cases, which may exhibit spontaneous pain due to tooth fracture) within the same quadrant as the study tooth that may interfere with assessment of sensitivity. 7. Study tooth diagnosed with cracked tooth syndrome. 8. Study tooth mobility \>= grade 2 using the Miller's tooth mobility index. 9. Study tooth has previous and current signs and symptoms of pulpal and/or periapical disease (e.g., root resorption or pulpal calcifications) or irreversible pulpitis (excluding pain from trauma cases). 10. Study tooth has no systemic mineralization pathology (e.g., amelogenesis imperfecta, enamel hypoplasia, etc.) 11. Study tooth that is not restorable 12. Study tooth that requires a crown preparation. 13. 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. 14. Study tooth has an existing restoration or requires a new restoration that interferes with radiographic assessments (e.g., caries on the buccal surface). Intra-operative Exclusion Criteria: 15. Study tooth exhibits bleeding of the exposed pulp that does not stop within 8 minutes.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Dental caries are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Can natural mouthwashes fight cavity bacteria as well as chlorhexidine?
- Tooth pulp test may reveal which deep cavities heal without a root canal
- Can a bonding layer make Kids' cavity sealants last longer?
- Could popular Weight-Loss drugs quietly reshape your mouth?
- Can dentists patch a failing baby tooth instead of drilling it out?
- Can a squeezable filling match the standard for cavities?