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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.
Full description
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.
Enrollment
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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.
Primary purpose
Allocation
Interventional model
Masking
350 participants in 1 patient group
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Central trial contact
Paula Myhre, MS; Sher-ree Beekman, MBA
Data sourced from clinicaltrials.gov
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