The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life

University of Michigan

Status and phase: Terminated; Phase 3

Conditions: Quality of Life; Cervical Abrasion

Treatments: Device: Photac-fil; Device: Biodentine

Study type: Interventional

Funder types: Other

Identifiers

NCT03304184

HUM00111890

Details and patient eligibility

About

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.

Full 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 mechanisms to attach to the teeth and may have different outcomes. The study will determine if one material is more effective in relieving chronic pain. In addition, we will evaluate changes in oral health related quality of life after the placement of the two different dental materials.

Enrollment: 24 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Photac-fil

Placebo Comparator group

Description:

Participants will have a restoration placed with photac-fil in the lesion near the gum line.

Treatment:

Device: Photac-fil

Biodentine

Experimental group

Description:

Participants will have a restoration placed with Biodentine in the lesion near the gum line.

Treatment:

Device: Biodentine