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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photac-fil | Placebo Comparator | Participants will have a restoration placed with photac-fil in the lesion near the gum line. |
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| Biodentine | Experimental | Participants will have a restoration placed with Biodentine in the lesion near the gum line. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photac-fil | Device | Application of a tooth colored filling in a non-cavitated dental lesion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Base Changes of Pain | A one survey description detailing the changes in pain over time based on the following scale:
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental School | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Biodentine |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Base Changes of Pain | A one survey description detailing the changes in pain over time based on the following scale:
| Global Base Changes of pain measured over 3 months | Posted | Mean | Standard Deviation | units on a scale | baseline, week1, week 2, 3 month follow up |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Debonding of Biodentine from area added | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Van Tubergen | University of Michigan | 2487045640 | evantub@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2018 | Apr 23, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2019 | Apr 23, 2021 | ICF_003.pdf |
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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.
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| Biodentine | Device | Application of a white colored filling in a non-cavitated dental lesion. |
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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. |
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| Primary | 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. | OHIP-49 score for Photac group measured over 3 months | Posted | Mean | Standard Deviation | total score | Baseline, week1, week 2, 3 month follow up |
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| Primary | 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. | Brief pain inventory measured over time | Posted | Mean | Standard Deviation | score on a scale | Baseline, week1, week 2, 3 month follow up |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 5 | 9 |
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| Week 2 measurement |
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| 3 month follow up |
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| Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used. | ANOVA | .0262 | Comparison between the two arms for treatment time points with analysis | Mean Difference (Final Values) | 3 | 2-Sided | 95 | The estimation values were from an average of all values in each arm. | Equivalence | In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine) over time points |
| Brief pain inventory score- week 2 |
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| Brief pain inventory score- 3 month recall |
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