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Is Professional Tooth Cleaning Necessary for Managing Gingivitis (Gingival Inflammation) if Subjects Use Intelligent Toothbrushes?

RecruitingNAAges 18 Years - 64 YearsAllShanghai Ninth People's Hospital Affiliated to Sh…
NCT07549347 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Optimal oral care regimen
  • Periodontal Treatment
  • Sham Periodontal Treatment
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Where

1 site
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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