Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients
NCT ID: NCT04546295
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2021-05-01
2022-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brushlink
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.
Brushlink application
Brushlink application + Interproximal brush
Interproximal brush
Interproximal brush alone
Water-flosser
This group will brush their teeth using a waterflosser that sprays the tooth with a small jet of water.
Water-flosser
Water-flosser
Interproximal brush
Interproximal brush alone
Interproximal Brush
This group will brush their teeth with only a toothbrush.
Interproximal brush
Interproximal brush alone
Interventions
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Brushlink application
Brushlink application + Interproximal brush
Water-flosser
Water-flosser
Interproximal brush
Interproximal brush alone
Eligibility Criteria
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Inclusion Criteria
* 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
* surgical periodontal therapy within the past year
40 Years
85 Years
ALL
No
Sponsors
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University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Amy C Killeen, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center, College of Dentistry
Lincoln, Nebraska, United States
Countries
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Other Identifiers
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0685-20-EP
Identifier Type: -
Identifier Source: org_study_id
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