The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
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|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
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life Cervical Abrasion||Device: Photac-fil Device: Biodentine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|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)|
|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|
Placebo Comparator: Photac-fil
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Application of a tooth colored filling in a non-cavitated dental lesion.
Other Name: Resin modified glass ionomer
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Application of a white colored filling in a non-cavitated dental lesion.
- 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:
- -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
- 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.
- 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.
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
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48109|