Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04546295 |
| Other study ID # |
0685-20-EP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
December 1, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
