Clinical trial NCT04546295: Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients
Official title: Effect of Smartphone Application on Reducing Localized Inflammation in Periodontal Maintenance Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Inflammation
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 6 weeks
Secondary outcomes:
measure: Bleeding on probing
timeFrame: 6 weeks
Other outcomes:
measure: IL-1 levels
timeFrame: 6 weeks
Locations:
city: Lincoln
country: United States
facility: University of Nebraska Medical Center, College of Dentistry
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Amy C Killeen, DDS
role: PRINCIPAL_INVESTIGATOR
References: