About this trial
Periodontitis is highly prevalent and develops from plaque-induced gingivitis. Managing gingivitis is key to preventing periodontitis and its complications. Professional mechanical plaque removal (PMPR) with oral hygiene guidance is effective for gingivitis, but large-scale implementation-especially in China-faces challenges such as workforce shortages. Meanwhile, patient compliance with daily oral hygiene remains poor. An optimal oral care regimen featuring an intelligent electric toothbrush (i-Brush) has shown promise in enhancing self-care adherence and efficiency. However, it remains unclear whether PMPR is still necessary when used in conjunction with this optimal oral care regimen. This study aims to verify whether the i-Brush-based regimen is non-inferior to the combination of PMPR and the regimen in improving gingival inflammation in gingivitis and stage I periodontitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≧18 years old and < 65 years old
Gingivitis, Stage I and Localized Stage II Periodontitis
With more than 20 teeth
Agree to use the electronic I-brush with the Oral-B APP
Disqualifiers
Presence of any systemic disease that can alter the outcome of periodontal treatment
Pregnancy or lactation during the study
Having received antibiotics within the previous 3 months
Having received professional periodontal treatment within the previous 3 months
Trial design
Parallel
Treatments tested in this trial
Optimal oral care regimen
BehavioralBoth groups will receive the optimal oral care regimen throughout the entire research period. This regimen comprises using a commercially available intelligent toothbrush connected to the Chinese consumer version of an application, receiving targeted oral health messages, and using dental floss.
Periodontal Treatment
DeviceAt baseline, the control group will receive standard professional mechanical plaque removal consisting of supra - and subgingival debridement using ultrasonic device.
Sham Periodontal Treatment
DeviceAt baseline, the test group will receive sham professional mechanical plaque removal consisting of cleaning the teeth with the same ultrasonic device but applied more than 2 mm away from the gingival margin.
Treatment groups
Trial outcomes
Primary outcomes
changes in full mouth bleeding score (FMBS)
changes of full mouth bleeding score after periodontal treatment
Secondary outcomes
changes in probing depth (PD)
changes of probing depth after periodontal treatment
changes in plaque index (PI)
changes of plaque index after periodontal treatment
changes in calculus surface index (CSI)
changes of calculus surface index after periodontal treatment
changes in oral biomarker concentration
changes of biomarker concentration (ng/ml) in saliva and oral rinse after periodontal treatment
Sponsors and contacts
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