Oral HygieneNCT03841825
Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients
A study testing Oral hygiene instructions in people with Oral Hygiene and White Spot Lesion, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study will compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements. Read more about this study
- Who is it for?
- Ages 11 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene, White Spot Lesion, Gingivitis
- What is being tested?
- Oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 11-20 that have their own mobile device
- Patients have cellular plan that allows them to receive text messages at no extra cost
- Patients that will undergo treatment with full fixed appliances
Who cannot join
- patients with significant medical or dental history, including patients with bleeding disorders that would require antibiotic prophylaxis
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients: a Randomized Clinical Trial
This study will compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements.
Read the detailed description
Orthodontic treatment (i.e. braces) makes it hard to keep good oral hygiene. The purpose of this research study is to compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements. Participation in this study will last up to 6 months and will consist of 4 study visits to the VCU Orthodontic clinic which are also regular visits for treatment. Measurements to assess participant's oral health will be taken during these visits. Participants will be randomly assigned to 1 of 4 groups which may include receiving different types of text messages, repeated in-person oral hygiene instructions, or both, or neither.
- Conditions
- Oral Hygiene, White Spot Lesion, Gingivitis
- Being tested
- Oral hygiene instructions
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene instructionsBehavioural
Oral hygiene instructions and motivation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No messages or oral hygiene instructions |
| Text message reminders | Experimental | Standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays Receives: Behavioral: Oral hygiene instructions |
| In-person oral hygiene instructions | Active comparator | Oral hygiene instructions and motivation during visit Receives: Behavioral: Oral hygiene instructions |
| Text messages and in-person instructions | Experimental | standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays and oral hygiene instructions and motivation during visit Receives: Behavioral: Oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 3-item Bleeding Index (BI)
Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding
Measured: Initial visit to 4 - 6 weeks
Change in 3-item Bleeding Index (BI)
Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding
Measured: 4 - 6 weeks to 8 - 12 weeks
Change in 3-item Bleeding Index (BI)
Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding
Measured: 8 - 12 weeks to 12 - 18 weeks
Secondary outcomes (6)
Change in 5-item Modified Gingival Index (MGI)
Dental examiner observation of inflammation during exam after wires have been removed and participant has brushed teeth. Ratings are 0=Absence of inflammation, 1=Mild inflammation (marginal or papillary unit), 2=Mild inflammation (entire marginal and papillary unit), 3=Moderate inflammation, 4=severe inflammation
Measured: Initial visit to 4 - 6 weeks
Change in 5-item Modified Gingival Index (MGI)
Dental examiner observation of inflammation during exam after wires have been removed and participant has brushed teeth. Ratings are 0=Absence of inflammation, 1=Mild inflammation (marginal or papillary unit), 2=Mild inflammation (entire marginal and papillary unit), 3=Moderate inflammation, 4=severe inflammation
Measured: 4 - 6 weeks to 8 - 12 weeks
Change in 5-item Modified Gingival Index (MGI)
Dental examiner observation of inflammation during exam after wires have been removed and participant has brushed teeth. Ratings are 0=Absence of inflammation, 1=Mild inflammation (marginal or papillary unit), 2=Mild inflammation (entire marginal and papillary unit), 3=Moderate inflammation, 4=severe inflammation
Measured: 8 - 12 weeks to 12 - 18 weeks
Change in 6 item Plaque index (PI)
Dental examiner observation of plaque during exam after wires have been removed and participant has brushed teeth. Ratings are 0= no plaque, 1=Discontinuous band of plaque at gingival margin, 2=Up to 1-mm continuous band of plaque at gingival margin, 3=Band of plaque wider than 1 mm but less than 1/3 of surface, 4=Plaque covering between 1/3 and 2/3 of surface, 5=Plaque covering 2/3 or more of surface
Measured: Initial visit to 4 - 6 weeks
Change in 6 item Plaque index (PI)
Dental examiner observation of plaque during exam after wires have been removed and participant has brushed teeth. Ratings are 0= no plaque, 1=Discontinuous band of plaque at gingival margin, 2=Up to 1-mm continuous band of plaque at gingival margin, 3=Band of plaque wider than 1 mm but less than 1/3 of surface, 4=Plaque covering between 1/3 and 2/3 of surface, 5=Plaque covering 2/3 or more of surface
Measured: 4 - 6 weeks to 8 - 12 weeks
Change in 6 item Plaque index (PI)
Dental examiner observation of plaque during exam after wires have been removed and participant has brushed teeth. Ratings are 0= no plaque, 1=Discontinuous band of plaque at gingival margin, 2=Up to 1-mm continuous band of plaque at gingival margin, 3=Band of plaque wider than 1 mm but less than 1/3 of surface, 4=Plaque covering between 1/3 and 2/3 of surface, 5=Plaque covering 2/3 or more of surface
Measured: 8 - 12 weeks to 12 - 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Feb 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shroff Bhavna, DDS, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841825
- Sponsor's protocol ID
- HM20014910
- Status last verified
- Sep 2020
- First submitted
- 12 Feb 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03841825
- Acronym / sponsor ID
- HM20014910
- Conditions
- Oral Hygiene, White Spot Lesion, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements.
Detailed description
Orthodontic treatment (i.e. braces) makes it hard to keep good oral hygiene. The purpose of this research study is to compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements. Participation in this study will last up to 6 months and will consist of 4 study visits to the VCU Orthodontic clinic which are also regular visits for treatment. Measurements to assess participant's oral health will be taken during these visits. Participants will be randomly assigned to 1 of 4 groups which may include receiving different types of text messages, repeated in-person oral hygiene instructions, or both, or neither.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No messages or oral hygiene instructions |
| Text message reminders | Experimental | Behavioral: Oral hygiene instructionsStandardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays |
| In-person oral hygiene instructions | Active comparator | Behavioral: Oral hygiene instructionsOral hygiene instructions and motivation during visit |
| Text messages and in-person instructions | Experimental | Behavioral: Oral hygiene instructionsstandardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays and oral hygiene instructions and motivation during visit |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 11-20 that have their own mobile device
- Patients have cellular plan that allows them to receive text messages at no extra cost
- Patients that will undergo treatment with full fixed appliances
Key exclusion criteria (2 listed)
- patients with significant medical or dental history, including patients with bleeding disorders that would require antibiotic prophylaxis
- Pregnant women
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 |
|---|---|---|
| Oral hygiene instructionsOral hygiene instructions and motivation | Behavioural | In-person oral hygiene instructions, Text message reminders, Text messages and in-person instructions |
Primary outcome
Change in 3-item Bleeding Index (BI)
Time frame: Initial visit to 4 - 6 weeks
Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding
Change in 3-item Bleeding Index (BI)
Time frame: 4 - 6 weeks to 8 - 12 weeks
Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding
Change in 3-item Bleeding Index (BI)
Time frame: 8 - 12 weeks to 12 - 18 weeks
Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding
6 secondary outcomes
Change in 5-item Modified Gingival Index (MGI)
Time frame: Initial visit to 4 - 6 weeks
Change in 5-item Modified Gingival Index (MGI)
Time frame: 4 - 6 weeks to 8 - 12 weeks
Change in 5-item Modified Gingival Index (MGI)
Time frame: 8 - 12 weeks to 12 - 18 weeks
Change in 6 item Plaque index (PI)
Time frame: Initial visit to 4 - 6 weeks
Change in 6 item Plaque index (PI)
Time frame: 4 - 6 weeks to 8 - 12 weeks
Change in 6 item Plaque index (PI)
Time frame: 8 - 12 weeks to 12 - 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- 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.
Shroff Bhavna, DDS principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hygiene instructions in people with Oral Hygiene and White Spot Lesion, run by Virginia Commonwealth University 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 3 inclusion and 2 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 10 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 3-item Bleeding Index (BI) (time frame: Initial visit to 4 - 6 weeks). 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 10 Sep 2020.