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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | 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. |
|
| Control group | Other | The control group will receive standard Professional Mechanical Plaque Removal consisting of supra- and subgingival debridement at baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimal oral care regimen | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in full mouth bleeding score (FMBS) | changes of full mouth bleeding score after periodontal treatment | from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in probing depth (PD) | changes of probing depth after periodontal treatment | from baseline to 6 months |
| changes in plaque index (PI) | changes of plaque index after periodontal treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Gao, Phd | Contact | 19818987186 | gr1015209095@163.com | |
| Maurizio Tonetti, DMD Phd | Contact | 15000102368 | maurizio.tonetti@ergoperio.eu |
| Name | Affiliation | Role |
|---|---|---|
| Maurizio Tonetti, DMD Phd | Shanghai PerioImplant Innovation Center, Ninth People Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38631679 | Background | Li Y, Wu X, Liu M, Deng K, Tullini A, Zhang X, Shi J, Lai H, Tonetti MS. Enhanced control of periodontitis by an artificial intelligence-enabled multimodal-sensing toothbrush and targeted mHealth micromessages: A randomized trial. J Clin Periodontol. 2024 Dec;51(12):1632-1643. doi: 10.1111/jcpe.13987. Epub 2024 Apr 17. | |
| 32748486 |
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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.
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Statistician and laboratory test assessors will also be masked
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| Periodontal Treatment | Device | At baseline, the control group will receive standard professional mechanical plaque removal consisting of supra - and subgingival debridement using ultrasonic device. |
|
| Sham Periodontal Treatment | 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. |
|
| from baseline to 6 months |
| changes in calculus surface index (CSI) | changes of calculus surface index after periodontal treatment | from baseline to 6 months |
| changes in oral biomarker concentration | changes of biomarker concentration (ng/ml) in saliva and oral rinse after periodontal treatment | from baseline to 6 months |
| changes in subgingival plaque taxa | changes of the taxa of subgingival plaque after periodontal treatment | 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 | from baseline to 6 months |
| Tonetti MS, Deng K, Christiansen A, Bogetti K, Nicora C, Thurnay S, Cortellini P. Self-reported bleeding on brushing as a predictor of bleeding on probing: Early observations from the deployment of an internet of things network of intelligent power-driven toothbrushes in a supportive periodontal care population. J Clin Periodontol. 2020 Oct;47(10):1219-1226. doi: 10.1111/jcpe.13351. Epub 2020 Aug 31. |
| 32383274 | Background | Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290. |
| 29926495 | Background | Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945. |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D010512 | Periodontal Index |
| ID | Term |
|---|---|
| D003753 | Dental Health Surveys |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003813 | Dentistry |
| D010517 | Periodontics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011636 | Public Health Dentistry |
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