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Dental InfectionNCT07016217

Evaluation of an Educational Intervention on Antibiotics in Dental Care

A study testing Early Plain Portrait and Letter, Early Complete Portrait and Letter and Delayed Plain Portrait and Letter in people with Dental Infection and Clindamycin, run by University of British Columbia at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this randomized trial is to estimate the impact of personalized prescribing portraits and educational materials on prescribing of antibiotic medications by dentists in British Columbia, Canada. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Dental Infection, Clindamycin, Antibiotics
What is being tested?
Early Plain Portrait and Letter, Early Complete Portrait and Letter and Delayed Plain Portrait and Letter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,498 participants
Where
1 siteCanada
Study dates
15 May 2023to 15 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Dentists registered with the BC College of Oral Health Professionals with an active dental practice in BC
  • Dentists in BC included in randomization groups 1-3 with at least 10 prescription orders filled for antibiotics in 2022
  • Patients aged >16
  • Patient prescribed antibiotic therapy by a BC dentist during, before, or after periods; Anatomical Therapeutic Chemical (ATC) classes J01
  • Patient was enrolled in MSP at least 1 month before the prescription

Who cannot join

  • Dentists not registered with the BC College of Oral Health Professionals
  • Dentists with fewer than 10 prescription orders filled in 2022
  • Patients used antibiotics in the last 14 days (prescribed by any prescriber, not only dentists) before the prescription; and
  • Federally insured BC residents and beneficiaries of the First Nations Health Benefit Plan; we were not given permission to use these data in our evaluation

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Therapeutics Initiative - Dept of Anesthesiology, Pharmacology & Therapeutics, Faculty of Medicine, University of British Columbia

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

About this study

Official title: Impact Evaluation of the Therapeutics Initiative's Mailed Dental Portrait and Therapeutics Letter

The goal of this randomized trial is to estimate the impact of personalized prescribing portraits and educational materials on prescribing of antibiotic medications by dentists in British Columbia, Canada.

The main research question is:

Read more

Did the prescribing Portraits and Therapeutics Letter lead to a change in clindamycin prescribing as a proportion of total antibiotic prescribing by dentists in British Columbia.

Study participants are dentists actively practicing in British Columbia. Participants were randomized to 3 study arms to received different combinations of one of two versions of the individual prescribing Portraits and a Therapeutics Letter in Early or Delayed Groups. Two versions of the prescribing Portrait were used: a "plain" version and a "complete" version, which included an additional section with self-reflection questions for clinicians.

Using administrative health data, the prescribing of those in different combinations of materials in the Early Group will be compared to those in the Delayed Group to estimate the impact of the materials on prescribing by the dentists.

Read the detailed description

Audit and feedback is a well-established strategy for improving the quality of care in primary healthcare settings. It involves the systematic collection and analysis of healthcare data, followed by the provision of information to healthcare providers to improve the quality of care.

Based in British Columbia, Canada, the Therapeutics Initiative's Portrait program provides physicians, and other health professionals, with individualized prescribing data compared with their peers, paired with evidence-based messaging, and a concise statement summarizing the desired change in prescribing behavior. The Portrait program implements a series of pragmatic trials to improve prescribing where clinicians are randomized into an early intervention and a delayed control group.

This study is a randomized trial examining the impact of prescribing Portraits on antibiotic prescribing by dentists in British Columbia. The Portrait title is "Which antibiotics do you prescribe for dental infections?" and is accompanied by a Therapeutics Letter entitled "Rethink Clindamycin for Dental Patient Safety." The materials were developed in collaboration with the BC Centre for Disease Control (BCCDC) and the BC College of Oral Health Professionals (BCCOHP).

When dentists prescribe antibiotics like clindamycin for dental infections, they often do so with the intention of combating bacterial growth. However, clindamycin come with a set of risks, notably the potential for Clostridium difficile infection (C. diff). This bacterium can proliferate in the gut when the normal balance of bacteria is disrupted by antibiotics, leading to symptoms ranging from mild diarrhea to severe colitis and life-threatening complications.

The main prescribing message for the dental Portrait is "clindamycin should not be used routinely for prophylaxis or management of dental infections." The Portrait has two different formats. The "plain" version includes the main message, prescriber's data (compare to optimal prescribing), and references. The "complete" version includes an additional series of self-reflection questions.

3498 dentists in British Columbia were randomized into three arms/groups (1166 in each group). For the Early mailing in Oct 2023, Arm A received the "plain" Portrait with a Therapeutics Letter; Arm B received a "complete" Portrait with a Letter, and Arm C received nothing. For the delayed mailing (April 2024), Arm A received the "complete" Portrait and Letter, Arm B received nothing, and Arm C received the "plain" Portrait and Letter.

The objective was to estimate the impact of the interventions (plain version of Portrait + Therapeutics Letter; Complete version of the Portrait + Therapeutics Letter; repeat messages) on prescribing of antibiotic medications by dentists in British Columbia.

The analysis will identify:

  • Baseline characteristics: Physicians and patients by study group (age, age groups, and sex).
  • Primary outcome: The change in clindamycin prescribing as a proportion of total antibiotic prescribing associated with the Portraits and Therapeutics Letter.

The investigators will identify the difference in the number of new starts of clindamycin after versus before the Early mailing date. New starters of clindamycin are defined as no antibiotic prescribed by any dentist in the previous year. Investigators will then calculate the mean difference among dentists in each of the comparison groups by estimating the odds ratio: adjust for clustering using GEE, with an interaction term between the randomization group id and time period, and with an independent correlation structure. Analysis assumes a normal distribution to derive confidence intervals. The difference between the comparison groups will be the estimated impact of the portrait.

Analysis will be conducted using secondary data from administrative databases from the BC Ministry of Health (under an Information Sharing Agreement). The data are patient level and include anonymized information about demographics, health costs, BC Medical Services Plan clinician services data, BC PharmaNet data (prescription drug dispensing at community pharmacies), client roster. The data do not include personally identifiable patient information.

Being tested
Early Plain Portrait and Letter, Early Complete Portrait and Letter, No intervention, Delayed Plain Portrait and Letter, Delayed Complete Portrait
Keywords
randomized controlled trial, dental infection, clindamycin, quality improvement, prescribing feedback, antibiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Plain Portrait and LetterBehavioural

    In the context of audit and feedback interventions, the prescribing Portrait is a document produced by the Therapeutics Initiative that provides personalized prescribing feedback for clinicians in British Columbia. Portraits are used as a practice resource tool for reflection on prescribing or test-ordering patterns.

    The Portraits provide data of individual prescribing along with evidence-based benchmarks or targets. The "plain" Portrait includes the main message, prescriber's data (compare to optimal prescribing, with or without information on BC mean/median). Prescribers are also given access to a succinct review of the best available evidence on the topic and recommendations for future action in the Therapeutics Letter, a standalone publication that details the evidence for the recommended practice in a brief and practical manner, with references.

  • Early Complete Portrait and LetterBehavioural

    In the context of audit and feedback interventions, the prescribing Portrait is a document produced by the Therapeutics Initiative that provides personalized prescribing feedback for clinicians in British Columbia. Portraits are used as a practice resource tool for reflection on prescribing or test-ordering patterns.

    The Portraits provide data of individual prescribing along with evidence-based benchmarks or targets. The "complete" Portrait includes the main message, prescriber's data (compare to optimal prescribing, with or without information on BC mean/median) and a series of self-reflection questions. Prescribers are also given access to a succinct review of the best available evidence on the topic and recommendations for future action in the Therapeutics Letter, a standalone publication that details the evidence for the recommended practice in a brief and practical manner, with references.

  • No interventionBehavioural

    To measure the impact of the interventions, Arm C (Group 3) will receive no intervention in the Early mailing and Arm B (Group 2) will receive no intervention in the Delayed mailing.

  • Delayed Plain Portrait and LetterBehavioural

    Delayed "plain" Portrait and Letter (as described)

  • Delayed Complete PortraitBehavioural

    Delayed "complete" Portrait and Letter (as described)

Study groups in NCT07016217
Study groupRoleWhat they receive
Arm A (Group 1) - Portrait + LetterExperimentalThis group received the "plain" Portrait with a Therapeutics Letter in the Early mailing (Oct 13, 2023), and received the "complete" Portrait with a Therapeutics Letter in the Delayed mailing (April 24, 2024).
Receives: Behavioral: Early Plain Portrait and Letter; Behavioral: Delayed Complete Portrait
Arm B (Group 2) - Portrait + LetterExperimentalThis group received the "complete" Portrait with a Therapeutics Letter in the Early mailing (Oct 13, 2023), and received nothing in the Delayed mailing (April 24, 2024).
Receives: Behavioral: Early Complete Portrait and Letter; Behavioral: No intervention
Arm C (Group 3) - ControlExperimentalThis group received nothing in the Early mailing (Oct 13, 2023) and received the "plain" Portrait with a Therapeutics Letter in the Delayed mailing (April 24, 2024).
Receives: Behavioral: No intervention; Behavioral: Delayed Plain Portrait and Letter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intention to treat analysis

    The primary outcome is the change in clindamycin prescribing (number of new starts) as a proportion of total antibiotic prescribing associated with the interventions.

    Measured: Assessed from the baseline until the early intervention (6 months) to 6 months after the delayed intervention (total of 18 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start15 May 2023
  3. Primary completion24 Oct 2024
  4. Study completion15 May 2027 (estimated)

Resources

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
Randomised
Intervention model
Sequential
Model description
The investigators randomized actively practicing dentists into three groups, n=1166 in each group for a total of 3498 individual dentists. For the Early mailing on Oct 13, 2023, Arm A/Group 1 received the "plain" Portrait with a Therapeutics Letter; Arm B/Group 2 received a "complete" Portrait with a Letter, and Arm C/ Group 3 received nothing (control group). For the delayed mailing (April 24, 2024), Arm A/Group 1 received the "complete" Portrait and Letter, Arm B/Group 2 received nothing, and Arm C/ Group 3 received the "plain" Portrait and Letter.
Masking
Single blind
Who is masked
Participant
Enrolment
3,498 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07016217
Sponsor's protocol ID
H23-01507
Status last verified
Jun 2025
First submitted
3 Jun 2025
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data access agreement for the Therapeutics Initiative does not permit sharing of IPD.

Questions about this trial

What is this clinical trial studying?

A study testing Early Plain Portrait and Letter, Early Complete Portrait and Letter and Delayed Plain Portrait and Letter in people with Dental Infection and Clindamycin, run by University of British Columbia at 1 site in Canada.

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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

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?

Intention to treat analysis (time frame: Assessed from the baseline until the early intervention (6 months) to 6 months after the delayed intervention (total of 18 months).). 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 11 Jun 2025.

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