A Multi-site, Single-Arm Clinical Study Evaluating the Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure Due to Trauma, Deep Caries, or Mechanical Etiology Under Dental Restorations
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Pulp Vitality at 1-year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vitrebond™ Pulp Protect Liner/Base
Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping
干预措施: Vitrebond™ Pulp Protect Liner/Base (Device)
结局指标
主要结局
Pulp Vitality at 1-year
时间窗: 1 year post-restoration
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.
次要结局
- Pulp Vitality at baseline, 3 months, 6 months, and 2, 3, 4, and 5 years(Baseline, 3 months, 6 months, and 2, 3, 4, and 5 years post-restoration.)
- Reparative dentin formation(6 months and 1 year, and only if taken at the 2-, 3-, 4-, and 5-year post-restoration)
- Apical periodontitis(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(6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration)
- External root resorption(6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration)
- Pulp canal obliteration(6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration)
- Pathological tooth mobility(baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration)
- Spontaneous pain(baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration)