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Completed

NCT Number: NCT04546295

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, 68583, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brushlink application

Other

Brushlink application + Interproximal brush

Water-flosser

Other

Water-flosser

Interproximal brush

Other

Interproximal brush alone

Primary outcomes

  1. Clinical Attachment Level

    Time frame: 6 weeks

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

Secondary outcomes

  1. Bleeding on probing

    Time frame: 6 weeks

    Incidence of bleeding during study probing of gums.

Other outcomes

  1. IL-1 levels

    Time frame: 6 weeks

    Pro-inflammatory biomarker (IL-1B) levels as determined in gingival crevicular fluid sampling.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 14, 2020
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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