Gingivitis, Periodontitis
Conditions
Keywords
artificial intelligence, internet of things network, oral hygiene instruction, professional mechanical plaque removal, mobile health
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Masking description
Statistician and laboratory test assessors will also be masked
Intervention model description
Non-inferiority study. If the non-inferiority hypothesis is rejected, a prespecified secondary analysis will be performed, stratifying by dental calculus status as a major prognostic factor.
Eligibility
Inclusion criteria
1. ≧18 years old and \< 65 years old 2. Gingivitis, Stage I and Localized Stage II Periodontitis 3. With more than 20 teeth 4. Agree to use the electronic I-brush with the Oral-B APP
Exclusion criteria
1. Presence of any systemic disease that can alter the outcome of periodontal treatment 2. Pregnancy or lactation during the study 3. Having received antibiotics within the previous 3 months 4. Having received professional periodontal treatment within the previous 3 months 5. With ongoing orthodontic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in full mouth bleeding score (FMBS) | from baseline to 6 months | changes of full mouth bleeding score after periodontal treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in probing depth (PD) | from baseline to 6 months | changes of probing depth after periodontal treatment |
| changes in plaque index (PI) | from baseline to 6 months | changes of plaque index after periodontal treatment |
| changes in calculus surface index (CSI) | from baseline to 6 months | changes of calculus surface index after periodontal treatment |
| changes in oral biomarker concentration | from baseline to 6 months | changes of biomarker concentration (ng/ml) in saliva and oral rinse after periodontal treatment |
| changes in subgingival plaque taxa | from baseline to 6 months | changes of the taxa of subgingival plaque after periodontal treatment |
| changes in patient reported outcomes | from baseline to 6 months | changes of patient reported outcomes evaluated by Oral Health Impact Profile-14 questionnaire after periodontal treatment |
Countries
China
Contacts
Shanghai PerioImplant Innovation Center, Ninth People Hospital