An interventional study of Vitrebond™ Pulp Protect Liner/Base in Dental Caries, Pulp Exposure, Dental and Tooth Decay, sponsored by Solventum US LLC. Terminated at 1 site in United States. Open to participants aged 7 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Solventum US LLC · Not applicable, Interventional, and Treatment
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Solventum US LLC is the lead sponsor of 62 studies on the registry; 2 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
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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:
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:
Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping
Device: Vitrebond™ Pulp Protect Liner/Base
Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping
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. Vital pulp (normal): Positive response from the pulp sensibility test that subsides within 5 seconds. 2. Reversible pulpitis: Positive response from pulp sensibility test that lasts greater than 5 seconds up to approximately 30 seconds. 3. Irreversible pulpitis: Prolonged positive response from pulp sensibility test that lasts more than approximately 30 seconds. 4. Non-vital pulp: Negative response from the pulp sensibility test.
Time frame: 1 year post-restoration
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: 1. Vital pulp (normal): Positive response from the pulp sensibility test that subsides within 5 seconds. 2. Reversible pulpitis: Positive response from pulp sensibility test that lasts greater than 5 seconds up to approximately 30 seconds. 3. Irreversible pulpitis: Prolonged positive response from pulp sensibility test that lasts more than approximately 30 seconds. 4. Non-vital pulp: Negative response from the pulp sensibility test.
Time frame: 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: 1. Presence of reparative dentin formation 2. Absence of reparative dentin formation
Time frame: 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: 1. Presence of apical periodontitis 2. Absence of apical periodontitis
Time frame: 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: 1. Presence of internal root resorption 2. Absence of internal root resorption
Time frame: 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: 1. Presence of external root resorptions 2. Absence of external root resorptions
Time frame: 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: 1. Presence of pulp canal obliteration 2. Absence of pulp canal obliteration
Time frame: 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: 1. Class 0: normal (physiologic) movement when force is applied 2. Class 1: \< 1 mm (horizontal) a. mobility greater than physiologic 3. Class 2: ≥1 mm (horizontal), 1. tooth can be moved 1 mm or more in a lateral direction (buccolingual or mesiodistal); and 2. inability to depress the tooth in a vertical direction (apicocoronal) 4. Class 3: ≥1 mm (horizontal and vertical) 1. tooth can be moved 1 mm or more in a lateral direction (buccolingual or mesiodistal); and 2. ability to depress the tooth in a vertical direction (apicocoronal)
Time frame: 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: 1. Presence of spontaneous pain 2. Absence of spontaneous pain
Time frame: baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration
Plan to share: No
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