Pit-and-Fissure SealantsDISGONCT04682730
An Implementation Strategy for the Adoption of an Evidence-Based Guideline for Pit-and-Fissure Sealants
A study testing Deliberative Loop in people with Pit-and-Fissure Sealants, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this implementation science study is to determine whether Deliberative Loops are effective in increasing providers' adherence to the non-cavitated caries component of the American Dental Association's pit-and-fissure sealant evidence-based clinical practice guideline. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pit-and-Fissure Sealants
- What is being tested?
- Deliberative Loop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 896 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 26 Jan 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed by Kaiser Permanente Northwest Dental or Permanente Dental Associates
- Work in a Kaiser Permanente Northwest dental clinic
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: An Implementation Strategy for the Adoption of an Evidence-Based Guideline for Pit-and-Fissure Sealants: Using a Framework From Organizational Development
The purpose of this implementation science study is to determine whether Deliberative Loops are effective in increasing providers' adherence to the non-cavitated caries component of the American Dental Association's pit-and-fissure sealant evidence-based clinical practice guideline. The investigators use a stepped wedge design to randomly assign dental clinics to the Deliberative Loop intervention. In a Deliberative Loop, stakeholders receive background information, participate in a facilitated discussion, and share their views with leadership. The Deliberative Loop intervention is designed to help stakeholders form informed opinions; in this study, stakeholders will be forming informed opinions about the implementation interventions they think will increase their clinic's adherence to the guideline. The investigators hypothesize that compared with the pre-intervention period, following the intervention, providers will place or treatment plan sealants for significantly more occlusal non-cavitated carious lesions.
Read the detailed description
The purpose of this implementation science study is to determine whether Deliberative Loops are effective in increasing providers' adherence to the non-cavitated caries component of the American Dental Association's pit-and-fissure sealant evidence-based clinical practice guideline. The investigators use a stepped wedge design to randomly assign dental clinics to the Deliberative Loop intervention. In a Deliberative Loop, stakeholders receive background information, participate in a facilitated discussion, and share their views with leadership. The Deliberative Loop intervention is designed to help stakeholders form informed opinions; in this study, stakeholders will be forming informed opinions about the implementation interventions they think will increase their clinic's adherence to the guideline. The investigators hypothesize that compared with the pre-intervention period, following the intervention, providers will place or treatment plan sealants for significantly more occlusal non-cavitated carious lesions (NCCL).
All persons employed by Kaiser Permanente Northwest or Permanente Dental Associates and who work in a Kaiser Permanente Northwest dental clinic at any level [e.g., part time, full time] will be eligible to participate in the study. This includes both service providers and front-of-the-house staff, approximately 1,200 employees.
This is a Stage III study.
Participating sites include the 16 general dental clinics of Kaiser Permanente Northwest. All clinics are located within the United States.
The estimated time from when the study opens to enrollment until completion of data collection is 16 months. It will take approximately one to two months for each individual participant to complete all study-related tasks, depending on how soon after the introductory session the Deliberative session can be scheduled.
- Conditions
- Pit-and-Fissure Sealants
- Being tested
- Deliberative Loop
- Keywords
- evidence-based clinical practice guideline, dental sealants, Deliberative Democracy, Deliberative Loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deliberative LoopBehavioural
The investigators will give background information to the stakeholders before they engage in the Deliberative session.
Stakeholders from a given clinic will come together for a Deliberative session (i.e., facilitated conversation), enabling them to hear the full range of perspectives held by their fellow colleagues and to share their own perspective regarding how best to implement the guideline in small-group discussions.
Following the Deliberative session, each stakeholder will have the opportunity to record their opinions regarding possible implementation interventions. The investigators will share these opinions with the clinic's decision-makers to help guide their decision-making about which implementation interventions to deploy. If a stakeholder happens to be absent the day of their clinic's Deliberative session, they will still have the opportunity to complete the survey.
| Study group | Role | What they receive |
|---|---|---|
| Deliberative Loop | Experimental | 28-page Context-Setting Document; 2-page addendum to Context-Setting Document; 90 minute Deliberative session; 8-page post-session survey Receives: Behavioral: Deliberative Loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Providers' Rates of Placing or Treatment Planning Sealants for Occlusal NCCLs
The change in the providers' rates of placing or treatment planning sealants for occlusal NCCLs from before to after clinic stakeholders are exposed to the Deliberative Loop intervention
Measured: from one month before the first step to two months after the final step, 1 year.
Secondary outcomes (9)
Total Program Costs
Program costs: Total intervention costs. Program cost analysis conducted for the Deliberative Loop (DL) intervention using an opportunity cost approach. Program costs were estimated for the DL intervention (Workbook development - including the guideline, EHR data analyses, initial practitioner survey, and evidence review - and printing; Online DL session facilitator training and delivery, and program tailoring; dental office staff time; costs for implemented strategies, if applicable; and allowed charges for dental sealant placements). All costs are reported in 2021 dollars. The study analysis period was Jan 1-Dec 31, 2021, and in 16 clinics during 2021.
Measured: from planning the survey to gather background information to two months after the final step; an average of 1 year
Cost Per Clinic
Program costs: Cost per clinic
Measured: from planning the survey to gather background information to two months after the final step; an average of 1 year
Cost Per Member Per Month (PMPM)
Total intervention costs per member per month. Program cost analysis conducted for the Deliberative Loop (DL) intervention using an opportunity cost approach. Program costs were estimated for the DL intervention (Workbook development - including the guideline, EHR data analyses, initial practitioner survey, and evidence review - and printing; Online DL session facilitator training and delivery, and program tailoring; dental office staff time; costs for implemented strategies, if applicable; and allowed charges for dental sealant placements). All costs are reported in 2021 dollars. The study analysis period was Jan 1-Dec 31, 2021, and in 16 clinics during 2021. There were 265,200 members age 6 years or more on January 1, 2021, or a total of 3,182,400 member months.
Measured: from planning the survey to gather background information to two months after the final step; an average of 1 year
Annualized Costs for Guideline Implementation Interventions
Program costs: Annualized costs for guideline implementation interventions
Measured: from planning the survey to gather background information to two months after the final step; an average of 1 year
NCCL Treatment Costs- Total Program Costs Per Sealant
Total intervention costs per sealant. Program cost analysis conducted for the Deliberative Loop (DL) intervention using an opportunity cost approach. Program costs were estimated for the DL intervention (Workbook development - including the guideline, EHR data analyses, initial practitioner survey, and evidence review - and printing; Online DL session facilitator training and delivery, and program tailoring; dental office staff time; costs for implemented strategies, if applicable; and allowed charges for dental sealant placements). All costs are reported in 2021 dollars. The study analysis period was Jan 1-Dec 31, 2021, and in 16 clinics during 2021. There were 95 sealants placed during the intervention period at 16 clinics.
Measured: from planning the survey to gather background information to two months after the final step; an average of 1 year
NCCL Treatment Costs- Total Program Costs Per Sealant Per Clinic
Program costs: NCCL treatment costs- Total program costs per sealant per clinic
Measured: from planning the survey to gather background information to two months after the final step; an average of 1 year
NCCL Treatment Costs- Per Sealant Per Member Per Month (PMPM)
Total intervention costs per sealant per member per month. Program cost analysis conducted for the Deliberative Loop (DL) intervention using an opportunity cost approach. Program costs were estimated for the DL intervention (Workbook development - including the guideline, EHR data analyses, initial practitioner survey, and evidence review - and printing; Online DL session facilitator training and delivery, and program tailoring; dental office staff time; costs for implemented strategies, if applicable; and allowed charges for dental sealant placements). All costs are reported in 2021 dollars. The study analysis period was Jan 1-Dec 31, 2021, and in 16 clinics during 2021. There were 95 sealants placed during the intervention period at 16 clinics. There were 265,200 members age 6 years or more on January 1, 2021, or a total of 3,182,400 member months.
Measured: from planning the survey to gather background information to two months after the final step; an average of 1 year
Sealant Treatment Plan Resolution
The count of occlusal NCCLs with a treatment plan for sealants that is sealed by the end of the post-intervention evaluation period.
Measured: when a clinic was exposed to the intervention (when they received their survey results) to December 31, 2021. (Vanguard- 9.34 months; Cluster 1- 7.84 months; Cluster 2- 6.39 months; Cluster 3- 5.30 months; Cluster 4- 3.33 months; Cluster 5- 2.75 months)
Cost Effectiveness
Estimated incremental cost-effectiveness ratios (ICERs) for clinics after exposure to the intervention. ICERs calculated for annualized total costs, costs per clinic, and costs PMPM.
Measured: from one month before the first step to two months after the final step, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion26 Jan 2022
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pit-and-Fissure SealantsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Stepped wedge. In addition to the vanguard clinic, there will be five steps, each with three clinics.
- Masking
- None (open label)
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Kaiser Permanente
- Responsible party
- Principal investigator, Deborah Polk, University of Pittsburgh
- Investigators
- Deborah E Polk, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682730
- Sponsor's protocol ID
- STUDY20020201
- Other IDs
- U01DE027452, 17-077-E
- Acronym
- DISGO
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2020
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD sharing plan includes sharing with other researchers all collected, deidentified IPD.
Publications
Dawson T, Kaplan CD, Polk DE. Public health and private healthcare: a directed content analysis of citizenship behavior in transcripts from online deliberative engagement among oral healthcare providers considering implementation of an evidence-based clinical practice guideline. BMC Oral Health. 2026 Jun 11. doi: 10.1186/s12903-026-08390-8. Online ahead of print.
PubMed 42277765Polk DE, Shah NH, Dawson T, Gruss I, Pihlstrom DJ, Kaplan CD, Guerrero EG, Fellows JL. Results from a cluster-randomized, stepped-wedge trial testing a deliberative engagement intervention to increase guideline adherence among U.S. oral health providers. Sci Rep. 2025 May 25;15(1):18180. doi: 10.1038/s41598-025-03236-9.
PubMed 40415002Gruss I, Dawson T, Kaplan CD, Pihlstrom DJ, Fellows JL, Polk DE. Utilizing deliberative engagement for identifying implementation strategy priorities: lessons learned from an online deliberative forum with dental professionals. Implement Sci Commun. 2023 Sep 21;4(1):119. doi: 10.1186/s43058-023-00496-2.
PubMed 37735706Gruss I, Dawson T, Kaplan CD, Pihlstrom DJ, Reich S, Fellows JL, Polk DE. Sharing voice during deliberative engagement to improve guideline adherence in dental clinics: findings from a qualitative evaluation of an online deliberative forum discussion. BMJ Open. 2023 Jul 5;13(7):e072727. doi: 10.1136/bmjopen-2023-072727.
PubMed 37407045Polk D, Shah NH, Dawson T, Gruss I, Pihlstrom DJ, Kaplan CD, Guerrero EG, Fellows JL. Testing a Deliberative Democracy Engagement Intervention to Increase Guideline-Concordance Among Oral Health Providers: Results from the DISGO Cluster-Randomized, Stepped-Wedge Trial. Res Sq [Preprint]. 2023 May 4:rs.3.rs-2757518. doi: 10.21203/rs.3.rs-2757518/v1.
PubMed 37205489Polk DE, Guerrero EG, Gruss I, Shah NH, Yosuf NM, Dawson T, Kaplan CD, Pihlstrom DJ, Fellows JL. Study protocol: A stepped-wedge, cluster-randomized trial of the effectiveness of a deliberative loop in identifying implementation strategies for the adoption of a dental sealant guideline in dental clinics. Implement Sci Commun. 2021 Aug 28;2(1):96. doi: 10.1186/s43058-021-00199-6.
PubMed 34454637
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Implementation Strategy for the Adoption of an Evidence-Based Guideline for Pit-and-Fissure Sealants: Using a Framework From Organizational Development
- ClinicalTrials.gov ID
- NCT04682730
- Acronym / sponsor ID
- DISGO / STUDY20020201
- Conditions
- Pit-and-Fissure Sealants
- Keywords
- evidence-based clinical practice guideline, dental sealants, Deliberative Democracy, Deliberative Loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Kaiser Permanente
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this implementation science study is to determine whether Deliberative Loops are effective in increasing providers' adherence to the non-cavitated caries component of the American Dental Association's pit-and-fissure sealant evidence-based clinical practice guideline. The investigators use a stepped wedge design to randomly assign dental clinics to the Deliberative Loop intervention. In a Deliberative Loop, stakeholders receive background information, participate in a facilitated discussion, and share their views with leadership. The Deliberative Loop intervention is designed to help stakeholders form informed opinions; in this study, stakeholders will be forming informed opinions about the implementation interventions they think will increase their clinic's adherence to the guideline. The investigators hypothesize that compared with the pre-intervention period, following the intervention, providers will place or treatment plan sealants for significantly more occlusal non-cavitated carious lesions.
Detailed description
The purpose of this implementation science study is to determine whether Deliberative Loops are effective in increasing providers' adherence to the non-cavitated caries component of the American Dental Association's pit-and-fissure sealant evidence-based clinical practice guideline. The investigators use a stepped wedge design to randomly assign dental clinics to the Deliberative Loop intervention. In a Deliberative Loop, stakeholders receive background information, participate in a facilitated discussion, and share their views with leadership. The Deliberative Loop intervention is designed to help stakeholders form informed opinions; in this study, stakeholders will be forming informed opinions about the implementation interventions they think will increase their clinic's adherence to the guideline. The investigators hypothesize that compared with the pre-intervention period, following the intervention, providers will place or treatment plan sealants for significantly more occlusal non-cavitated carious lesions (NCCL).
All persons employed by Kaiser Permanente Northwest or Permanente Dental Associates and who work in a Kaiser Permanente Northwest dental clinic at any level [e.g., part time, full time] will be eligible to participate in the study. This includes both service providers and front-of-the-house staff, approximately 1,200 employees.
This is a Stage III study.
Participating sites include the 16 general dental clinics of Kaiser Permanente Northwest. All clinics are located within the United States.
The estimated time from when the study opens to enrollment until completion of data collection is 16 months. It will take approximately one to two months for each individual participant to complete all study-related tasks, depending on how soon after the introductory session the Deliberative session can be scheduled.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped wedge. In addition to the vanguard clinic, there will be five steps, each with three clinics.
| Arm | Type | Receives |
|---|---|---|
| Deliberative Loop | Experimental | Behavioral: Deliberative Loop28-page Context-Setting Document; 2-page addendum to Context-Setting Document; 90 minute Deliberative session; 8-page post-session survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employed by Kaiser Permanente Northwest Dental or Permanente Dental Associates
- Work in a Kaiser Permanente Northwest dental clinic
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Deliberative LoopThe investigators will give background information to the stakeholders before they engage in the Deliberative session. Stakeholders from a given clinic will come together for a Deliberative session (i.e., facilitated conversation), enabling them to hear the full range of perspectives held by their fellow colleagues and to share their own perspective regarding how best to implement the guideline in small-group discussions. Following the Deliberative session, each stakeholder will have the opportunity to record their opinions regarding possible implementation interventions. The investigators will share these opinions with the clinic's decision-makers to help guide their decision-making about which implementation interventions to deploy. If a stakeholder happens to be absent the day of their clinic's Deliberative session, they will still have the opportunity to complete the survey. | Behavioural | Deliberative Loop |
Primary outcome
Change in Providers' Rates of Placing or Treatment Planning Sealants for Occlusal NCCLs
Time frame: from one month before the first step to two months after the final step, 1 year.
The change in the providers' rates of placing or treatment planning sealants for occlusal NCCLs from before to after clinic stakeholders are exposed to the Deliberative Loop intervention
9 secondary outcomes
Total Program Costs
Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year
Cost Per Clinic
Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year
Cost Per Member Per Month (PMPM)
Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year
Annualized Costs for Guideline Implementation Interventions
Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year
NCCL Treatment Costs- Total Program Costs Per Sealant
Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year
NCCL Treatment Costs- Total Program Costs Per Sealant Per Clinic
Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year
NCCL Treatment Costs- Per Sealant Per Member Per Month (PMPM)
Time frame: from planning the survey to gather background information to two months after the final step; an average of 1 year
Sealant Treatment Plan Resolution
Time frame: when a clinic was exposed to the intervention (when they received their survey results) to December 31, 2021. (Vanguard- 9.34 months; Cluster 1- 7.84 months; Cluster 2- 6.39 months; Cluster 3- 5.30 months; Cluster 4- 3.33 months; Cluster 5- 2.75 months)
Cost Effectiveness
Time frame: from one month before the first step to two months after the final step, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42277765Dawson T, Kaplan CD, Polk DE. Public health and private healthcare: a directed content analysis of citizenship behavior in transcripts from online deliberative engagement among oral healthcare providers considering implementation of an evidence-based clinical practice guideline. BMC Oral Health. 2026 Jun 11. doi: 10.1186/s12903-026-08390-8. Online ahead of print.
- Derived from this study: PubMed 40415002Polk DE, Shah NH, Dawson T, Gruss I, Pihlstrom DJ, Kaplan CD, Guerrero EG, Fellows JL. Results from a cluster-randomized, stepped-wedge trial testing a deliberative engagement intervention to increase guideline adherence among U.S. oral health providers. Sci Rep. 2025 May 25;15(1):18180. doi: 10.1038/s41598-025-03236-9.
- Derived from this study: PubMed 37735706Gruss I, Dawson T, Kaplan CD, Pihlstrom DJ, Fellows JL, Polk DE. Utilizing deliberative engagement for identifying implementation strategy priorities: lessons learned from an online deliberative forum with dental professionals. Implement Sci Commun. 2023 Sep 21;4(1):119. doi: 10.1186/s43058-023-00496-2.
- Derived from this study: PubMed 37407045Gruss I, Dawson T, Kaplan CD, Pihlstrom DJ, Reich S, Fellows JL, Polk DE. Sharing voice during deliberative engagement to improve guideline adherence in dental clinics: findings from a qualitative evaluation of an online deliberative forum discussion. BMJ Open. 2023 Jul 5;13(7):e072727. doi: 10.1136/bmjopen-2023-072727.
- Derived from this study: PubMed 37205489Polk D, Shah NH, Dawson T, Gruss I, Pihlstrom DJ, Kaplan CD, Guerrero EG, Fellows JL. Testing a Deliberative Democracy Engagement Intervention to Increase Guideline-Concordance Among Oral Health Providers: Results from the DISGO Cluster-Randomized, Stepped-Wedge Trial. Res Sq [Preprint]. 2023 May 4:rs.3.rs-2757518. doi: 10.21203/rs.3.rs-2757518/v1.
- Derived from this study: PubMed 34454637Polk DE, Guerrero EG, Gruss I, Shah NH, Yosuf NM, Dawson T, Kaplan CD, Pihlstrom DJ, Fellows JL. Study protocol: A stepped-wedge, cluster-randomized trial of the effectiveness of a deliberative loop in identifying implementation strategies for the adoption of a dental sealant guideline in dental clinics. Implement Sci Commun. 2021 Aug 28;2(1):96. doi: 10.1186/s43058-021-00199-6.
- Individual participant dataSharing planned: Yes. The IPD sharing plan includes sharing with other researchers all collected, deidentified IPD.
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Pits and Fissure Sealants
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.
Deborah E Polk, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deliberative Loop in people with Pit-and-Fissure Sealants, run by University of Pittsburgh 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jul 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2023). 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?
Change in Providers' Rates of Placing or Treatment Planning Sealants for Occlusal NCCLs (time frame: from one month before the first step to two months after the final step, 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682730, which also lists 6 linked publications.
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 12 Jul 2023.