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

Phase 3

Terminated

• Conditions: Cervical Abrasion; Quality of Life
• Interventions: Device: Photac-fil; Device: Biodentine

• Registration Number: NCT03304184
• Lead Sponsor: University of Michigan

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 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.

Study Timeline

• Study Start: 2017-09-28
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-06
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-09
• Disposition First Submitted: 2020-10-03
• Results First Submitted: 2021-03-25
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-28
• Disposition First Submitted QC: 2021-06-28
• Last Update Submitted: 2021-06-28
• Results First Posted: 2021-07-19
• Disposition First Posted: 2021-07-19
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photac-fil	Photac-fil	Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Biodentine	Biodentine	Participants will have a restoration placed with Biodentine in the lesion near the gum line.

Primary Outcome Measures

Name	Time	Method
Global Base Changes of Pain	baseline, week1, week 2, 3 month follow up	A one survey description detailing the changes in pain over time based on the following scale: 1. -No change (or condition has gotten worse); 2. -Almost the same, hardly any change at all; 3. -A little better, but no noticeable change; 4. -Somewhat better, but the change has not made any real difference; 5. -Moderately better, and a slight but noticeable change; 6. -Better and a definite improvement that has made a real and worthwhile difference; 7. -A great deal better and a considerable improvement that has made all the difference
Oral Health Related Quality of Life Using a Survey With 49 Questions	Baseline, week1, week 2, 3 month follow up	A survey of 49 questions to assess oral health related quality of life. The scale measured 49 questions with a yes (1) or no (0) answers with a possible range of 0-49. The more answers of yes will indicate a higher score on the survey, which describes poorer oral health related quality of life. A lower number reflects better oral health related quality of life. A maximum score of 49 is the worst outcome.
Brief Pain Inventory	Baseline, week1, week 2, 3 month follow up	6 questions were used to measure pain on a sliding scale from 1-100 at each time point. The scale ranged from 1 being no pain and 100 being extreme pain. The higher the number reflects worse the pain compared to a lower number. The maximum range from the participants was 600 (maximum) and the lowest range of 0 for all questions. The data reflects the averaged sum for each time point for all patients in each arm.

Trial Locations

Locations (1)

Dental School; 🇺🇸 Ann Arbor, Michigan, United States