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

NCT07549347 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Gingivitis
  • Periodontitis

Interventions

BEHAVIORAL

Optimal oral care regimen

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.

DEVICE

Periodontal Treatment

At baseline, the control group will receive standard professional mechanical plaque removal consisting of supra - and subgingival debridement using ultrasonic device.

DEVICE

Sham Periodontal Treatment

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 & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Principal Investigators

  • Maurizio Tonetti, DMD Phd · Shanghai PerioImplant Innovation Center, Ninth People Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2027-03-01
Completion
2027-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07549347 on ClinicalTrials.gov