Cervical Abrasion, Quality of Life
Conditions
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.
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.
Interventions
DEVICEPhotac-fil
Application of a tooth colored filling in a non-cavitated dental lesion.
DEVICEBiodentine
Application of a white colored filling in a non-cavitated dental lesion.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Base Changes of Pain | 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 |
| Oral Health Related Quality of Life Using a Survey With 49 Questions | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 9 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Photac-fil | Biodentine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 9 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 8 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 9 |
| other Total, other adverse events | 0 / 15 | 5 / 9 |
| serious Total, serious adverse events | 0 / 15 | 0 / 9 |
Outcome results
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.
Time frame: Baseline, week1, week 2, 3 month follow up
Population: Brief pain inventory measured over time
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photac-fil | Brief Pain Inventory | Brief pain inventory score- 3 month recall | 55 score on a scale | Standard Deviation 96.4 |
| Photac-fil | Brief Pain Inventory | Brief pain inventory score- week 1 | 103.1 score on a scale | Standard Deviation 122.8 |
| Photac-fil | Brief Pain Inventory | Brief pain inventory score- baseline | 152.4 score on a scale | Standard Deviation 106.3 |
| Photac-fil | Brief Pain Inventory | Brief pain inventory score- week 2 | 91 score on a scale | Standard Deviation 134.8 |
| Biodentine | Brief Pain Inventory | Brief pain inventory score- 3 month recall | 76.8 score on a scale | Standard Deviation 122.3 |
| Biodentine | Brief Pain Inventory | Brief pain inventory score- week 2 | 66.8 score on a scale | Standard Deviation 71.7 |
| Biodentine | Brief Pain Inventory | Brief pain inventory score- baseline | 192.6 score on a scale | Standard Deviation 169.5 |
| Biodentine | Brief Pain Inventory | Brief pain inventory score- week 1 | 141.1 score on a scale | Standard Deviation 179.1 |
Comparison: Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.p-value: 0.0289ANOVA
Primary
Global Base Changes of Pain
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
Time frame: baseline, week1, week 2, 3 month follow up
Population: Global Base Changes of pain measured over 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photac-fil | Global Base Changes of Pain | Global base changes-baseline | 3.2 units on a scale | Standard Deviation 2.4 |
| Photac-fil | Global Base Changes of Pain | Global base changes-week 1 | 5.9 units on a scale | Standard Deviation 1.6 |
| Photac-fil | Global Base Changes of Pain | Global base changes-week 2 | 6.3 units on a scale | Standard Deviation 0.6 |
| Photac-fil | Global Base Changes of Pain | Global base changes-3 month follow up | 6.4 units on a scale | Standard Deviation 0.6 |
| Biodentine | Global Base Changes of Pain | Global base changes-3 month follow up | 4.6 units on a scale | Standard Deviation 2.4 |
| Biodentine | Global Base Changes of Pain | Global base changes-baseline | 2.3 units on a scale | Standard Deviation 2.1 |
| Biodentine | Global Base Changes of Pain | Global base changes-week 2 | 4.5 units on a scale | Standard Deviation 2.2 |
| Biodentine | Global Base Changes of Pain | Global base changes-week 1 | 4.6 units on a scale | Standard Deviation 2.3 |
Comparison: Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.p-value: 0.0001ANOVA
Comparison: Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.p-value: 0.0005ANOVA
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.
Time frame: Baseline, week1, week 2, 3 month follow up
Population: OHIP-49 score for Photac group measured over 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photac-fil | Oral Health Related Quality of Life Using a Survey With 49 Questions | Baseline measurement | 11.5 total score | Standard Deviation 11.2 |
| Photac-fil | Oral Health Related Quality of Life Using a Survey With 49 Questions | Week 1 measurement | 5.5 total score | Standard Deviation 8.1 |
| Photac-fil | Oral Health Related Quality of Life Using a Survey With 49 Questions | Week 2 measurement | 4.5 total score | Standard Deviation 6.9 |
| Photac-fil | Oral Health Related Quality of Life Using a Survey With 49 Questions | 3 month follow up | 2.6 total score | Standard Deviation 5.1 |
| Biodentine | Oral Health Related Quality of Life Using a Survey With 49 Questions | 3 month follow up | 4.9 total score | Standard Deviation 7 |
| Biodentine | Oral Health Related Quality of Life Using a Survey With 49 Questions | Baseline measurement | 14.4 total score | Standard Deviation 14.6 |
| Biodentine | Oral Health Related Quality of Life Using a Survey With 49 Questions | Week 2 measurement | 7.4 total score | Standard Deviation 11.5 |
| Biodentine | Oral Health Related Quality of Life Using a Survey With 49 Questions | Week 1 measurement | 12.7 total score | Standard Deviation 18.9 |
Comparison: Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.p-value: 0.091ANOVA
Comparison: Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.p-value: 0.0262ANOVA