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

NCT03304184 | Terminated Phase 3 Results FDA Device

• 1 other identifier: HUM00111890
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Cervical Abrasion

Outcome Measures

Primary Outcomes (3)

• Global Base Changes of Pain

  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

  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

Study Arms (2)

Photac-fil

PLACEBO COMPARATOR

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

Device: Photac-fil

Biodentine

EXPERIMENTAL

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

Device: Biodentine

Interventions

Photac-fil DEVICE

Application of a tooth colored filling in a non-cavitated dental lesion.

Also known as: Resin modified glass ionomer

Photac-fil

Biodentine DEVICE

Application of a white colored filling in a non-cavitated dental lesion.

Biodentine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Dental School

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Elizabeth Van Tubergen
• Organization: University of Michigan

evantub@umich.edu

2487045640

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant professor

Model Details: One group will be treated with a tooth colored filling that will be placed near the gum line. The second group will be treated with a white colored filling that will be placed near the gum line.

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 6, 2017
• Study Start: September 28, 2017
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: July 19, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)