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

Sponsor
University of Nebraska (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04546295
Collaborator
(none)
66
1
3
19
3.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Brushlink application
  • Other: Water-flosser
  • Other: Interproximal brush
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients.
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brushlink

Other: Brushlink application
Brushlink application + Interproximal brush

Other: Interproximal brush
Interproximal brush alone

Active Comparator: Water-flosser

Other: Water-flosser
Water-flosser

Other: Interproximal brush
Interproximal brush alone

Placebo Comparator: Interproximal Brush

Other: Interproximal brush
Interproximal brush alone

Outcome Measures

Primary Outcome Measures

  1. Clinical Attachment Level [6 weeks]

Secondary Outcome Measures

  1. Bleeding on probing [6 weeks]

Other Outcome Measures

  1. IL-1 levels [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UNMC College of Dentistry Lincoln Nebraska United States 68583

Sponsors and Collaborators

  • University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amy C. Killeen, DDS, MS, Associate Professor, University of Nebraska
ClinicalTrials.gov Identifier:
NCT04546295
Other Study ID Numbers:
  • Brushlink
First Posted:
Sep 14, 2020
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022