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

NCT04546295 | Completed

• 1 other identifier: 0685-20-EP
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Inflammation

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Level

  Measured level of clinical attachment (periodontal ligament oncementum on the root surfaces of teeth)

  6 weeks

Secondary Outcomes (1)

• Bleeding on probing

  6 weeks

Other Outcomes (1)

• IL-1 levels

  6 weeks

Study Arms (3)

Brushlink

EXPERIMENTAL

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.

Other: Brushlink application; Other: Interproximal brush

Water-flosser

ACTIVE COMPARATOR

This group will brush their teeth using a waterflosser that sprays the tooth with a small jet of water.

Other: Water-flosser; Other: Interproximal brush

Interproximal Brush

PLACEBO COMPARATOR

This group will brush their teeth with only a toothbrush.

Other: Interproximal brush

Interventions

Brushlink application OTHER

Brushlink application + Interproximal brush

Brushlink

Water-flosser OTHER

Water-flosser

Water-flosser

Interproximal brush OTHER

Interproximal brush alone

Brushlink; Interproximal Brush; Water-flosser

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• systemic diseases that significantly affect periodontal inflammation and bone turnover
• surgical periodontal therapy within the past year

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, 68583, United States

Location

Study Officials

• Amy C Killeen, DDS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)