- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546295
Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients
Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68583
- University of Nebraska Medical Center, College of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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:
- systemic diseases that significantly affect periodontal inflammation and bone turnover
- surgical periodontal therapy within the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 + Interproximal brush
Interproximal brush alone
|
Active Comparator: Water-flosser
This group will brush their teeth using a waterflosser that sprays the tooth with a small jet of water.
|
Interproximal brush alone
Water-flosser
|
Placebo Comparator: Interproximal Brush
This group will brush their teeth with only a toothbrush.
|
Interproximal brush alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Attachment Level
Time Frame: 6 weeks
|
Measured level of clinical attachment (periodontal ligament oncementum on the root surfaces of teeth)
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding on probing
Time Frame: 6 weeks
|
Incidence of bleeding during study probing of gums.
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IL-1 levels
Time Frame: 6 weeks
|
Pro-inflammatory biomarker (IL-1B) levels as determined in gingival crevicular fluid sampling.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy C Killeen, DDS, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0685-20-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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