Trial Outcomes & Findings for The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life (NCT NCT03304184)
NCT ID: NCT03304184
Last Updated: 2021-07-19
Results Overview
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
TERMINATED
PHASE3
24 participants
baseline, week1, week 2, 3 month follow up
2021-07-19
Participant Flow
Participant milestones
| Measure |
Photac-fil
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.
|
Biodentine
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
9
|
|
Overall Study
COMPLETED
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Photac-fil
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.
|
Biodentine
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
Baseline characteristics by cohort
| Measure |
Photac-fil
n=15 Participants
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.
|
Biodentine
n=9 Participants
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week1, week 2, 3 month follow upPopulation: Global Base Changes of pain measured over 3 months
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
Outcome measures
| Measure |
Photac-fil
n=15 Participants
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.
|
Biodentine
n=9 Participants
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.
|
|---|---|---|
|
Global Base Changes of Pain
Global base changes-baseline
|
3.2 units on a scale
Standard Deviation 2.4
|
2.3 units on a scale
Standard Deviation 2.1
|
|
Global Base Changes of Pain
Global base changes-week 1
|
5.9 units on a scale
Standard Deviation 1.6
|
4.6 units on a scale
Standard Deviation 2.3
|
|
Global Base Changes of Pain
Global base changes-week 2
|
6.3 units on a scale
Standard Deviation .6
|
4.5 units on a scale
Standard Deviation 2.2
|
|
Global Base Changes of Pain
Global base changes-3 month follow up
|
6.4 units on a scale
Standard Deviation .6
|
4.6 units on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Baseline, week1, week 2, 3 month follow upPopulation: OHIP-49 score for Photac group measured over 3 months
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.
Outcome measures
| Measure |
Photac-fil
n=15 Participants
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.
|
Biodentine
n=9 Participants
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.
|
|---|---|---|
|
Oral Health Related Quality of Life Using a Survey With 49 Questions
Baseline measurement
|
11.5 total score
Standard Deviation 11.2
|
14.4 total score
Standard Deviation 14.6
|
|
Oral Health Related Quality of Life Using a Survey With 49 Questions
Week 1 measurement
|
5.5 total score
Standard Deviation 8.1
|
12.7 total score
Standard Deviation 18.9
|
|
Oral Health Related Quality of Life Using a Survey With 49 Questions
Week 2 measurement
|
4.5 total score
Standard Deviation 6.9
|
7.4 total score
Standard Deviation 11.5
|
|
Oral Health Related Quality of Life Using a Survey With 49 Questions
3 month follow up
|
2.6 total score
Standard Deviation 5.1
|
4.9 total score
Standard Deviation 7.0
|
PRIMARY outcome
Timeframe: Baseline, week1, week 2, 3 month follow upPopulation: Brief pain inventory measured over time
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.
Outcome measures
| Measure |
Photac-fil
n=15 Participants
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.
|
Biodentine
n=9 Participants
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.
|
|---|---|---|
|
Brief Pain Inventory
Brief pain inventory score- week 2
|
91 score on a scale
Standard Deviation 134.8
|
66.8 score on a scale
Standard Deviation 71.7
|
|
Brief Pain Inventory
Brief pain inventory score- 3 month recall
|
55 score on a scale
Standard Deviation 96.4
|
76.8 score on a scale
Standard Deviation 122.3
|
|
Brief Pain Inventory
Brief pain inventory score- baseline
|
152.4 score on a scale
Standard Deviation 106.3
|
192.6 score on a scale
Standard Deviation 169.5
|
|
Brief Pain Inventory
Brief pain inventory score- week 1
|
103.1 score on a scale
Standard Deviation 122.8
|
141.1 score on a scale
Standard Deviation 179.1
|
Adverse Events
Photac-fil
Biodentine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Photac-fil
n=15 participants at risk
Participants will have a restoration placed with photac-fil in the lesion near the gum line.
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.
|
Biodentine
n=9 participants at risk
Participants will have a restoration placed with Biodentine in the lesion near the gum line.
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.
|
|---|---|---|
|
Product Issues
Debonding of Biodentine from area added
|
0.00%
0/15 • Adverse events were collected over the first two weeks of the placement of Biodentine as the material debonded from the tooth.
If any of the treatment arms have a deviation as a result of the restoration falling out or debonding, it is not a serious adverse event because the tooth was not prepped prior to the placement of the restoration. This would result in the area of the tooth that lost the restoration going back to the pre-treatment form. This would also not result in any risk of mortality.
|
55.6%
5/9 • Number of events 5 • Adverse events were collected over the first two weeks of the placement of Biodentine as the material debonded from the tooth.
If any of the treatment arms have a deviation as a result of the restoration falling out or debonding, it is not a serious adverse event because the tooth was not prepped prior to the placement of the restoration. This would result in the area of the tooth that lost the restoration going back to the pre-treatment form. This would also not result in any risk of mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place