Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients
Condition: Periodontal Inflammation
MeSH terms: Inflammation
Study type: Interventional

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.
    

Intervention name(s): Brushlink application; Water-flosser; Interproximal brush
Intervention type(s): Other; Other; Other
Intervention description(s): Brushlink application + Interproximal brush; Water-flosser; Interproximal brush alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment