Status:
TERMINATED
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
Lead Sponsor:
University of Michigan
Conditions:
Quality of Life
Cervical Abrasion
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The study will compare two different dental materials on dental lesions near the gum line that cause chronic pain on oral health related quality of life.
Detailed Description
The study will compare two different dental materials on dental lesions near the gum line. One of the materials is tooth colored and the other material is white but both materials use different mechan...
Eligibility Criteria
Inclusion
- Males and females age 18-64
- 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
- Pregnant women
- 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
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03304184
Start Date
September 28 2017
End Date
October 9 2019
Last Update
July 19 2021
Active Locations (1)
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1
Dental School
Ann Arbor, Michigan, United States, 48109