Periodontitis Clinical Trials

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Optimal Oral Care Regimen With or Without Professional Mechanical Plaque Removal in Managing Gingivitis (Gingival Inflammation): A Non-inferiority Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• ≧18 years old and \< 65 years old

• Gingivitis, Stage I and Localized Stage II Periodontitis

• With more than 20 teeth

• Agree to use the electronic I-brush with the Oral-B APP

Locations
Other Locations
China
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Rui Gao, Phd
gr1015209095@163.com
19818987186
Backup
Maurizio Tonetti, DMD Phd
maurizio.tonetti@ergoperio.eu
15000102368
Time Frame
Start Date: 2026-03-09
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 92
Treatments
Experimental: Test group
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.
Other: Control group
The control group will receive standard Professional Mechanical Plaque Removal consisting of supra- and subgingival debridement at baseline.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

This content was sourced from clinicaltrials.gov