Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated early due to a business decision by the sponsor.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research study is looking at the safety and effectiveness of Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping (DPC) on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. Dental pulp is the part of the tooth that contains the nerves, blood vessels, and cells that keep teeth healthy. The DPC procedure is done by dentists to help preserve tooth health if there is pulp exposure during the tooth restoration or due to trauma. Participants must have at least one permanent tooth with pulp exposure that needs DPC to be eligible for the study.
This is a multi-site, single-arm, prospective clinical study evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base treatment for direct pulp capping on permanent teeth. Vitrebond™ Pulp Protect Liner/Base is a new product designed to be placed under dental fillings that can be used as a "Liner/Base" to create a lining between the tooth and the filling to reduce sensitivity, and for direct pulp capping if there is a small amount of dental pulp exposed during the restoration.
The purpose of this clinical study will be to assess the effectiveness and safety of Vitrebond™ Pulp Protect for direct pulp capping on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. The primary objective is to evaluate Vitrebond™ Pulp Protect Liner/Base in maintaining pulp vitality (a measure of tooth health) when used for pulp capping, measured at 1-year post-restoration. The secondary objective of this study is to evaluate treated teeth for abnormal clinical signs or symptoms for up to 5 years after treatment to assess long-term safety and effectiveness. The success of Vitrebond™ Pulp Protect for direct pulp capping in this single-arm clinical study will be determined based on an assessment of pulp vitality one year after restoration compared to a pre-specified performance goal derived from literature using calcium hydroxide as the reference comparator.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitrebond™ Pulp Protect Liner/Base | Experimental | Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrebond™ Pulp Protect Liner/Base | Device | Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulp Vitality at 1-year | Pulp vitality, assessed by pulp sensibility testing using a refrigerant spray intended for dental use. A positive response from the pulp sensibility test is indicative of the pulp vitality of the tooth (primary endpoint). Categories for pulp vitality will include:
| 1 year post-restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Pulp Vitality at baseline, 3 months, 6 months, and 2, 3, 4, and 5 years | Pulp vitality, assessed by pulp sensibility testing using a refrigerant spray intended for dental use. A positive response from the pulp sensibility test is indicative of the pulp vitality of the tooth (primary endpoint). Categories for pulp vitality will include:
|
Not provided
Inclusion Criteria:
Subject is age 7 years or older at time of consent.
Subject is in good general health (i.e., meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).
Subject or Subject's Legally Authorized Representative is able and willing to understand and sign an Informed Consent Form or give Assent, as applicable.
Subject is able and willing to return in-person for all scheduled study visits.
Subject is able and willing to follow study restrictions.
Subject has existing dental radiographic images of the study teeth of current and acceptable diagnostic quality taken within 3 months of tooth restoration.
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.
Study tooth has no pre-operative sensitivity or exhibit pre-operative sensitivity that is relieved immediately after stimulus removal.
Study tooth has a positive response to a sensibility test (i.e., cold test using a refrigerant spray).
Study tooth can be restored with a direct permanent restoration (stepwise caries removal will not be used).
Study teeth are on opposite right/left sides of the mouth (for Subjects with more than one candidate study tooth).
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:
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:
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 (e.g., use of a rubber dam) or the length of time required to complete the restoration(s) on the study tooth/teeth.
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 (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.
Study tooth diagnosed with cracked tooth syndrome.
Study tooth mobility >= grade 2 using the Miller's tooth mobility index.
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).
Study tooth has no systemic mineralization pathology (e.g., amelogenesis imperfecta, enamel hypoplasia, etc.)
Study tooth that is not restorable
Study tooth that requires a crown preparation.
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.
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:
Study tooth exhibits bleeding of the exposed pulp that does not stop within 8 minutes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mabi Singh, DMD, BDS, MS | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Miller, S.C, Textbook of periodontia, Blakiston Company, Philidelphia, 1938 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D003789 | Dental Pulp Exposure |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D003788 | Dental Pulp Diseases |
Not provided
Not provided
Multi-site, single arm clinical study
Not provided
Not provided
Not provided
Not provided
| Baseline, 3 months, 6 months, and 2, 3, 4, and 5 years post-restoration. |
| Reparative dentin formation | Signs of reparative dentin formation assessed by bitewing (for posterior teeth) or periapical (for anterior teeth) radiographs taken at scheduled follow-up visits. Reparative dentin formation is desired. Categories for reparative dentin formation will include:
| 6 months and 1 year, and only if taken at the 2-, 3-, 4-, and 5-year post-restoration |
| Apical periodontitis | Apical periodontitis will be assessed by the clinician based on clinical assessments of symptoms (percussion of teeth, palpation of nearby bone, and visual examination of tissues) as well as periapical radiographs taken at scheduled follow-up visits. Absence of apical periodontitis is desired. Categories for apical periodontitis (symptomatic and/or asymptomatic) formation will include:
| 6-months and 1-year post-restoration, and at 2-, 3-, 4-, and 5-years post-restoration if periapical radiographs are taken |
| Internal root resorption | Internal root resorption will be assessed by periapical radiographs taken at each scheduled follow-up visit at 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-year follow-up visits and any unscheduled visits involving study teeth. Absence of internal root resorption is desired. Categories for internal root resorption will include:
| 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration |
| External root resorption | External root resorption will be assessed by periapical radiographs taken at each scheduled follow-up visit at 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-year follow-up visits and any unscheduled visits involving study teeth. Absence of external root resorption is desired. Categories for external root resorption will include:
| 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration |
| Pulp canal obliteration | Pulp canal obliteration will be assessed by periapical radiographs taken at each scheduled follow-up visit at 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-year follow-up visits and any unscheduled visits involving study teeth. Absence of pulp canal obliteration is desired. Categories for pulp canal obliteration will include:
| 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration |
| Pathological tooth mobility | Pathological tooth mobility will be assessed by clinicians at scheduled visits. The American Academy of Periodontology definition of tooth mobility is the movement of a tooth in its socket resulting from an applied force. Categories for pathological tooth mobility using the Miller's tooth mobility index will include:
| baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration |
| Spontaneous pain | Spontaneous pain not due to a stimulus will be self-assessed by subjects for each study tooth at scheduled visits. The baseline spontaneous pain assessment should be conducted a minimum of 3 hours after completing the restoration to allow time for the anesthesia to wear off. The baseline assessment may be conducted via phone to ask the subject if they are experiencing any spontaneous pain in the study tooth and must be completed within 1 week of the tooth restoration. The absence of spontaneous pain is desired. Spontaneous pain is defined as prolonged intense pain that doesn't respond to over-the-counter pain medication, and/or pain that wakes you up from sleep. Categories for spontaneous pain will include:
| baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration |