Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients
Primary Purpose
Periodontal Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brushlink application
Water-flosser
Interproximal brush
Sponsored by

About this trial
This is an interventional treatment trial for Periodontal Inflammation
Eligibility Criteria
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
Sites / Locations
- University of Nebraska Medical Center, College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Brushlink
Water-flosser
Interproximal Brush
Arm Description
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.
This group will brush their teeth using a waterflosser that sprays the tooth with a small jet of water.
This group will brush their teeth with only a toothbrush.
Outcomes
Primary Outcome Measures
Clinical Attachment Level
Measured level of clinical attachment (periodontal ligament oncementum on the root surfaces of teeth)
Secondary Outcome Measures
Bleeding on probing
Incidence of bleeding during study probing of gums.
Full Information
NCT ID
NCT04546295
First Posted
September 4, 2020
Last Updated
September 26, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT04546295
Brief Title
Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients
Official Title
Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brushlink
Arm Type
Experimental
Arm Description
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.
Arm Title
Water-flosser
Arm Type
Active Comparator
Arm Description
This group will brush their teeth using a waterflosser that sprays the tooth with a small jet of water.
Arm Title
Interproximal Brush
Arm Type
Placebo Comparator
Arm Description
This group will brush their teeth with only a toothbrush.
Intervention Type
Other
Intervention Name(s)
Brushlink application
Intervention Description
Brushlink application + Interproximal brush
Intervention Type
Other
Intervention Name(s)
Water-flosser
Intervention Description
Water-flosser
Intervention Type
Other
Intervention Name(s)
Interproximal brush
Intervention Description
Interproximal brush alone
Primary Outcome Measure Information:
Title
Clinical Attachment Level
Description
Measured level of clinical attachment (periodontal ligament oncementum on the root surfaces of teeth)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Bleeding on probing
Description
Incidence of bleeding during study probing of gums.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
IL-1 levels
Description
Pro-inflammatory biomarker (IL-1B) levels as determined in gingival crevicular fluid sampling.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy C Killeen, DDS
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, College of Dentistry
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients
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