Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT07549347

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

Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2026-04-24

92

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to less than 65 years
  • Diagnosed with Gingivitis, Stage I or Localized Stage II Periodontitis
  • Have more than 20 teeth
  • Agree to use the electronic i-Brush with the Oral-B app
Not Eligible

You will not qualify if you...

  • Have any systemic disease that may affect periodontal treatment outcomes
  • Pregnant or lactating during the study
  • Received antibiotics within the previous 3 months
  • Received professional periodontal treatment within the previous 3 months
  • Currently undergoing orthodontic treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

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Research Team

R

Rui Gao, Phd

CONTACT

M

Maurizio Tonetti, DMD Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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