The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
NCT ID: NCT03304184
Last Updated: 2021-07-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
24 participants
INTERVENTIONAL
2017-09-28
2019-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Photac-fil
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Photac-fil
Application of a tooth colored filling in a non-cavitated dental lesion.
Biodentine
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Biodentine
Application of a white colored filling in a non-cavitated dental lesion.
Interventions
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Photac-fil
Application of a tooth colored filling in a non-cavitated dental lesion.
Biodentine
Application of a white colored filling in a non-cavitated dental lesion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chief complaint associated with pain from cold or hot
* Chronic sensitivity associated with supragingival lesions
* Pain not associated with decay
* Fluent in English and able to read English at a 6th grade level
* Pulpal response \<40 via pulp tester
* Active salivary flow from palpation of parotid and submandibular glands
* Patients self reporting pain over 6/10 in the past week and/or the past 2 months
Exclusion Criteria
* Patients taking benzodiazepines, narcotics and multiple antidepressants for pain management not associated with the oral cavity
* Unexplained dry mouth
* Patients taking two or more medications associated with dry mouth
* Pulpal response \>40 via pulp tester
* Patients requiring treatment for more than 5 decayed sites, periodontal disease and root canal therapy
* Complicated medical history (\>4 concurrent treatment for systemic diseases)
* Lesion \>1mm below the gum line
18 Years
64 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Elizabeth Van Tubergen
Clinical Assistant professor
Locations
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Dental School
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00111890
Identifier Type: -
Identifier Source: org_study_id
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