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
Last Update Posted : October 12, 2020
|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 :||25 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.
- Tooth pain using a survey of six questions [ Time Frame: 3 months ]A survey of six questions will assess tooth sensitivity
- Oral health related quality of life using a survey with 49 questions [ Time Frame: 3 months ]A survey with 49 questions will assess oral health related quality of life
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|