BACKGROUND
Compliance to oral hygiene is an important aspect in the treatment of periodontal disease. The use of behavioral techniques such as motivational interviewing is of great interest both in primary and secondary prevention of periodontal disease. However, it was shown that patients forget 40-80% of the information given during a medical consultation and up to 50% of what they think to remember is incorrect. An innovative eHealth solution (personalized video of oral hygiene routine available for the patient via a cloud server + interactive text messages) could help overcoming these difficulties.
OBJECTIVE
The primary objective was to evaluate whether the addition of an eHealth solution to the standard of care (SOC) could improve oral hygiene after an 8 weeks follow-up. The improvement of gingival inflammation after 8 weeks of follow-up was the main secondary objective.
METHODS
This study is a multicenter, randomized, controlled trial. Participants were randomized with a 1:1 allocation ratio: test group (eHealth + SOC) versus control group (SOC only). The minimum sample size required was 86 participants. The primary outcome was the full mouth (six sites per tooth) plaque control record (PCR) index, using a plaque disclosing agent. The main secondary outcome was the full mouth (six sites per tooth) bleeding on probing (BOP) index. Both the primary and the main secondary outcomes were evaluated by blinded and calibrated examiners at baseline and at 8 weeks of follow-up.
RESULTS
No significant difference was shown between the two groups for the PCR (p=0.882) and BOP (p=0.848). However, a 10.4% decrease of the PCR was found in the test group (11% in the control group) as well as a 7.7% decrease of the BOP (8.4% in the control group). The patient satisfaction was high in both groups (74.5% in the test group and 70.3% in the control group).
CONCLUSIONS
This 8-weeks multicenter randomized clinical trial of an eHealth solution for oral hygiene motivation failed to show a clinical benefit in terms of plaque control or gingival inflammation. However, the patient satisfaction was high, and this study was the first to demonstrate the technical and clinical feasibility of this concept.
CLINICALTRIAL
NCT03109808
INTERNATIONAL REGISTERED REPORT
RR2-10.1186/s13063-019-3738-0