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

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Cervical Abrasion
• Intervention / Treatment: Device: Photac-fil; Device: Biodentine

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Photac-fil; Participants will have a restoration placed with photac-fil in the lesion near the gum line.	Device: Photac-fil; Application of a tooth colored filling in a non-cavitated dental lesion.; Other Names: Resin modified glass ionomer
EXPERIMENTAL: Biodentine; Participants will have a restoration placed with Biodentine in the lesion near the gum line.	Device: Biodentine; Application of a white colored filling in a non-cavitated dental lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Base Changes of Pain	A one survey description detailing the changes in pain over time based on the following scale: -No change (or condition has gotten worse); -Almost the same, hardly any change at all; -A little better, but no noticeable change; -Somewhat better, but the change has not made any real difference; -Moderately better, and a slight but noticeable change; -Better and a definite improvement that has made a real and worthwhile difference; -A great deal better and a considerable improvement that has made all the difference	baseline, week1, week 2, 3 month follow up
Oral Health Related Quality of Life Using a Survey With 49 Questions	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.	Baseline, week1, week 2, 3 month follow up
Brief Pain Inventory	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.	Baseline, week1, week 2, 3 month follow up

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2017
• Primary Completion (ACTUAL): October 9, 2019
• Study Completion (ACTUAL): October 9, 2019

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (ACTUAL): October 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HUM00111890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes