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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03304184
Recruitment Status : Terminated (COVID)
First Posted : October 6, 2017
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Elizabeth Van Tubergen, 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.

Condition or disease Intervention/treatment Phase
Quality of Life Cervical Abrasion Device: Photac-fil Device: Biodentine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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 Name: 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.




Primary Outcome Measures :
  1. Global Base Changes of Pain [ Time Frame: 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

  2. Oral Health Related Quality of Life Using a Survey With 49 Questions [ Time Frame: 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.

  3. Brief Pain Inventory [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304184


Locations
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United States, Michigan
Dental School
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  Study Documents (Full-Text)

Documents provided by Elizabeth Van Tubergen, University of Michigan:
Informed Consent Form  [PDF] March 21, 2019

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Responsible Party: Elizabeth Van Tubergen, Clinical Assistant professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03304184    
Other Study ID Numbers: HUM00111890
First Posted: October 6, 2017    Key Record Dates
Results First Posted: July 19, 2021
Last Update Posted: July 19, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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