NCT07549347 Is Professional Tooth Cleaning Necessary for Managing Gingivitis (Gingival Inflammation) if Subjects Use Intelligent Toothbrushes?
| NCT ID | NCT07549347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Condition | Gingivitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2026-03-09 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Maurizio Tonetti, DMD Phd
PRINCIPAL INVESTIGATOR
Shanghai PerioImplant Innovation Center, Ninth People Hospital
Frequently Asked Questions
Who can join the NCT07549347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Gingivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07549347 currently recruiting?
Yes, NCT07549347 is actively recruiting participants. Contact the research team at gr1015209095@163.com for enrollment information.
Where is the NCT07549347 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07549347 clinical trial?
NCT07549347 is sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. The principal investigator is Maurizio Tonetti, DMD Phd at Shanghai PerioImplant Innovation Center, Ninth People Hospital. The trial plans to enroll 92 participants.