An interventional study of Optimal oral care regimen and Periodontal Treatment in Gingivitis and Periodontitis, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
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.
Periodontitis is highly prevalent and develops from gingivitis caused by plaque accumulation. Managing gingivitis is the "best-buy" approach for preventing periodontitis and avoiding its local and systemic sequelae. Professional mechanical plaque removal (PMPR), which aims at removing plaque biofilm and dental calculus, is generally considered effective in treating gingivitis when provided in the context of oral hygiene instructions. However, delivering PMPR to large populations such as the Chinese population poses formidable challenges, including the formation of an adequate workforce. Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. However, many studies have shown poor patient compliance with routine oral hygiene instruction. A new technology based on an intelligent electric toothbrush (i-Brush) and the Internet of Things shows good application prospects. A previous study has verified the effectiveness of optimal oral care regimens, which involve the use of an i-brush and the application of standard toothpaste, in enhancing the adherence and performance of self-performed oral hygiene, leading to significant savings and a more effective allocation of healthcare resources. However, it is unclear whether PMPR still plays an important role when combined with such optimal oral care regimens in managing gingivitis and early-stage periodontitis. This study aims to determine whether the effect of the optimal oral care regimen in improving gingival inflammation in gingivitis and stage I periodontitis is not inferior to the effect of the combination with PMPR.
Exclusion Criteria:
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 at baseline.
Behavioral: Optimal oral care regimen · Device: Sham Periodontal Treatment
The control group will receive standard Professional Mechanical Plaque Removal consisting of supra- and subgingival debridement at baseline.
Behavioral: Optimal oral care regimen · Device: Periodontal Treatment
Both 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.
At baseline, the control group will receive standard professional mechanical plaque removal consisting of supra - and subgingival debridement using ultrasonic device.
At 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.
changes in full mouth bleeding score (FMBS)
changes of full mouth bleeding score after periodontal treatment
Time frame: from baseline to 6 months
changes in probing depth (PD)
changes of probing depth after periodontal treatment
Time frame: from baseline to 6 months
changes in plaque index (PI)
changes of plaque index after periodontal treatment
Time frame: from baseline to 6 months
changes in calculus surface index (CSI)
changes of calculus surface index after periodontal treatment
Time frame: from baseline to 6 months
changes in oral biomarker concentration
changes of biomarker concentration (ng/ml) in saliva and oral rinse after periodontal treatment
Time frame: from baseline to 6 months
changes in subgingival plaque taxa
changes of the taxa of subgingival plaque after periodontal treatment
Time frame: from baseline to 6 months
changes in patient reported outcomes
changes of patient reported outcomes evaluated by Oral Health Impact Profile-14 questionnaire after periodontal treatment
Time frame: from baseline to 6 months
Plan to share: No
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University