Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients

September 26, 2023 updated by: University of Nebraska

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.

Study Overview

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

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nebraska
      • Lincoln, Nebraska, United States, 68583
        • University of Nebraska Medical Center, College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amy C Killeen, DDS, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

September 4, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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