Periodontal InflammationNCT04546295
Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients
A study testing Brushlink application, Water-flosser and Interproximal brush in people with Periodontal Inflammation, run by University of Nebraska at 1 site in United States.
Trial summary
The intent of this study is to determine the effect of a smartphone application used in conjunction with interproximal cleaning on localized, inflamed periodontal pockets of periodontal maintenance patients. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Periodontal Inflammation
- What is being tested?
- Brushlink application, Water-flosser and Interproximal brush
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Dec 2022
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a periodontal diagnosis of moderate-advanced chronic periodontitis,
- one 5-7 mm interproximal probing depth (test site) with 2 mm between inferior border of contact and gingival margin
- overall good systemic health
- history of regular PMT, and ownership of a smartphone device
Who cannot join
- systemic diseases that significantly affect periodontal inflammation and bone turnover
- surgical periodontal therapy within the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, College of Dentistry
Lincoln, Nebraska, 68583
About this study
Official title: Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients.
The intent of this study is to determine the effect of a smartphone application used in conjunction with interproximal cleaning on localized, inflamed periodontal pockets of periodontal maintenance patients. The hypothesis to be tested is that the use of the smartphone application will decrease clinical parameters of inflammation (probing depths, bleeding on probing) as well as the pro-inflammatory biomarker (IL-1B) as determined in gingival crevicular fluid sampling.
Read the detailed description
Numerous studies have shown that high quality home care (oral hygiene) is key in achieving stability in periodontal patients. Any technology that can potentially improve a patient's home care could be instrumental in decreasing periodontal inflammation and therefore could improve a patient's overall oral health.
The clinical phase of this 6-week, randomized, single-masked, interventional clinical trial will include randomization of 66 individuals regularly attending the University of Nebraska Medical Center College of Dentistry for periodontal maintenance therapy (PMT). The inclusion criteria for the study will include patients between the ages of 40-85 years, a periodontal diagnosis of moderate-advanced chronic periodontitis, one 5-7 mm interproximal probing depth (test site) with 2 mm between inferior border of contact and gingival margin, overall good systemic health, history of regular PMT, and ownership of a smartphone device. Exclusion criteria will eliminate patients with systemic diseases that significantly affect periodontal inflammation and bone turnover, and surgical periodontal therapy within the past year. Following informed consent, patients will be randomly assigned to one of three groups (22 patients per group): one group will receive instruction in the use of an interproximal cleaner with the Brushlink® app at the test site (BL), one group will receive instruction in the use of a water-flosser at the test site, and one group will receive instruction in the use of an interproximal cleaner (IP) alone at the test site. Groups will be randomized by gender and smoking status by a clinician not involved with clinical measurements. Measurements of plaque index (PI), gingival index (GI), probing depth (PD), recession and gingival crevicular fluid (GCF) samples will obtained at baseline and 6 weeks by one of three calibrated clinicians (AK, RR, LS). During data collection, supragingival plaque will be removed (and recorded), then an absorbent paper strip will be inserted into the facial and lingual sulci of the test site for 30 seconds for collection of GCF. Following data collection, patients will be instructed to use either the interproximal brush + Brushlink®, water-flosser, or interproximal cleaner alone at the test site once daily for 6 weeks. Patients will return at 6 weeks for clinical measurements and GCF sampling. The GCF samples will be analyzed via ELISA for the inflammatory biomarker, IL-1B. Clinical data will be submitted to statistical analysis to determine differences between groups with p-values </= 0.05 being considered statistically significant.
- Conditions
- Periodontal Inflammation
- Being tested
- Brushlink application, Water-flosser, Interproximal brush
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brushlink applicationOther
Brushlink application + Interproximal brush
Water-flosserOther
Water-flosser
Interproximal brushOther
Interproximal brush alone
| Study group | Role | What they receive |
|---|---|---|
| Brushlink | Experimental | This group will use Brushlink and interdental cleaner. The Brushlink app downloaded to participant's cell phone. A small Brushlink device is attached to participant's toothbrush. When participant's brush their teeth, the device on the toothbrush will send information to the app on your phone about how long teeth are brushed and at what angle the toothbrush is being held against the tooth. Receives: Other: Brushlink application; Other: Interproximal brush |
| Water-flosser | Active comparator | This group will brush their teeth using a waterflosser that sprays the tooth with a small jet of water. Receives: Other: Water-flosser; Other: Interproximal brush |
| Interproximal Brush | Placebo comparator | This group will brush their teeth with only a toothbrush. Receives: Other: Interproximal brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
Measured level of clinical attachment (periodontal ligament oncementum on the root surfaces of teeth)
Measured: 6 weeks
Secondary outcomes (1)
Bleeding on probing
Incidence of bleeding during study probing of gums.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 May 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy C Killeen, DDS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546295
- Sponsor's protocol ID
- 0685-20-EP
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2020
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients.
- ClinicalTrials.gov ID
- NCT04546295
- Acronym / sponsor ID
- 0685-20-EP
- Conditions
- Periodontal Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 Sep 2020 (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.
The intent of this study is to determine the effect of a smartphone application used in conjunction with interproximal cleaning on localized, inflamed periodontal pockets of periodontal maintenance patients. The hypothesis to be tested is that the use of the smartphone application will decrease clinical parameters of inflammation (probing depths, bleeding on probing) as well as the pro-inflammatory biomarker (IL-1B) as determined in gingival crevicular fluid sampling.
Detailed description
Numerous studies have shown that high quality home care (oral hygiene) is key in achieving stability in periodontal patients. Any technology that can potentially improve a patient's home care could be instrumental in decreasing periodontal inflammation and therefore could improve a patient's overall oral health.
The clinical phase of this 6-week, randomized, single-masked, interventional clinical trial will include randomization of 66 individuals regularly attending the University of Nebraska Medical Center College of Dentistry for periodontal maintenance therapy (PMT). The inclusion criteria for the study will include patients between the ages of 40-85 years, a periodontal diagnosis of moderate-advanced chronic periodontitis, one 5-7 mm interproximal probing depth (test site) with 2 mm between inferior border of contact and gingival margin, overall good systemic health, history of regular PMT, and ownership of a smartphone device. Exclusion criteria will eliminate patients with systemic diseases that significantly affect periodontal inflammation and bone turnover, and surgical periodontal therapy within the past year. Following informed consent, patients will be randomly assigned to one of three groups (22 patients per group): one group will receive instruction in the use of an interproximal cleaner with the Brushlink® app at the test site (BL), one group will receive instruction in the use of a water-flosser at the test site, and one group will receive instruction in the use of an interproximal cleaner (IP) alone at the test site. Groups will be randomized by gender and smoking status by a clinician not involved with clinical measurements. Measurements of plaque index (PI), gingival index (GI), probing depth (PD), recession and gingival crevicular fluid (GCF) samples will obtained at baseline and 6 weeks by one of three calibrated clinicians (AK, RR, LS). During data collection, supragingival plaque will be removed (and recorded), then an absorbent paper strip will be inserted into the facial and lingual sulci of the test site for 30 seconds for collection of GCF. Following data collection, patients will be instructed to use either the interproximal brush + Brushlink®, water-flosser, or interproximal cleaner alone at the test site once daily for 6 weeks. Patients will return at 6 weeks for clinical measurements and GCF sampling. The GCF samples will be analyzed via ELISA for the inflammatory biomarker, IL-1B. Clinical data will be submitted to statistical analysis to determine differences between groups with p-values </= 0.05 being considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brushlink | Experimental | Other: Brushlink application, Other: Interproximal brushThis group will use Brushlink and interdental cleaner. The Brushlink app downloaded to participant's cell phone. A small Brushlink device is attached to participant's toothbrush. When participant's brush their teeth, the device on the toothbrush will send information to the app on your phone about how long teeth are brushed and at what angle the toothbrush is being held against the tooth. |
| Water-flosser | Active comparator | Other: Water-flosser, Other: Interproximal brushThis group will brush their teeth using a waterflosser that sprays the tooth with a small jet of water. |
| Interproximal Brush | Placebo comparator | Other: Interproximal brushThis group will brush their teeth with only a toothbrush. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a periodontal diagnosis of moderate-advanced chronic periodontitis,
- one 5-7 mm interproximal probing depth (test site) with 2 mm between inferior border of contact and gingival margin
- overall good systemic health
- history of regular PMT, and ownership of a smartphone device
Key exclusion criteria (2 listed)
- systemic diseases that significantly affect periodontal inflammation and bone turnover
- surgical periodontal therapy within the past year
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 |
|---|---|---|
| Brushlink applicationBrushlink application + Interproximal brush | Other | Brushlink |
| Water-flosserWater-flosser | Other | Water-flosser |
| Interproximal brushInterproximal brush alone | Other | Brushlink, Interproximal Brush, Water-flosser |
Primary outcome
Clinical Attachment Level
Time frame: 6 weeks
Measured level of clinical attachment (periodontal ligament oncementum on the root surfaces of teeth)
1 secondary outcome
Bleeding on probing
Time frame: 6 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 28 Sep 2023.
- 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.
Amy C Killeen, DDS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brushlink application, Water-flosser and Interproximal brush in people with Periodontal Inflammation, run by University of Nebraska 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 4 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 28 Sep 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. 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.
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?
Clinical Attachment Level (time frame: 6 weeks). 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 28 Sep 2023.