Quality of LifePhase 3NCT03304184
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
A Phase 3 study testing Photac-fil and Biodentine in people with Quality of Life and Cervical Abrasion, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Quality of Life, Cervical Abrasion
- What is being tested?
- Photac-fil and Biodentine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 9 Oct 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Quality of Life, Cervical Abrasion
- Being tested
- Photac-fil, Biodentine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photac-filDevice
Also called Resin modified glass ionomer
Application of a tooth colored filling in a non-cavitated dental lesion.
BiodentineDevice
Application of a white colored filling in a non-cavitated dental lesion.
| Study group | Role | What they receive |
|---|---|---|
| Photac-fil | Placebo comparator | Participants will have a restoration placed with photac-fil in the lesion near the gum line. Receives: Device: Photac-fil |
| Biodentine | Experimental | Participants will have a restoration placed with Biodentine in the lesion near the gum line. Receives: Device: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Base Changes of Pain
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
Measured: 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.
Measured: 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.
Measured: Baseline, week1, week 2, 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start28 Sep 2017
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Van Tubergen, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304184
- Sponsor's protocol ID
- HUM00111890
- Status last verified
- Jun 2021
- First submitted
- 3 Oct 2017
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
- ClinicalTrials.gov ID
- NCT03304184
- Acronym / sponsor ID
- HUM00111890
- Conditions
- Quality of Life, Cervical Abrasion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 19 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Photac-fil | Placebo comparator | Device: Photac-filParticipants will have a restoration placed with photac-fil in the lesion near the gum line. |
| Biodentine | Experimental | Device: BiodentineParticipants will have a restoration placed with Biodentine in the lesion near the gum line. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photac-filAlso: Resin modified glass ionomerApplication of a tooth colored filling in a non-cavitated dental lesion. | Device | Photac-fil |
| BiodentineApplication of a white colored filling in a non-cavitated dental lesion. | Device | Biodentine |
Primary outcome
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: 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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Photac-fil and Biodentine in people with Quality of Life and Cervical Abrasion, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Base Changes of Pain (time frame: baseline, week1, week 2, 3 month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.