Do intelligent electric toothbrushes replace professional tooth cleaning for gum inflammation?
Official title: Optimal Oral Care Regimen With or Without Professional Mechanical Plaque Removal in Managing Gingivitis (Gingival Inflammation): A Non-inferiority Randomized Controlled Trial
Run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · NCT07549347 · Data updated 2026-11-12
We will test whether using an intelligent electric toothbrush with an oral-care routine can control gum inflammation in adults with gingivitis or early periodontitis as well as adding professional tooth cleaning.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT07549347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with gingivitis or stage I/localized stage II periodontitis who have more than 20 teeth and agree to use the i‑Brush with the Oral‑B app are ideal candidates.
✕Probably not a fit
People with advanced periodontitis, systemic diseases affecting periodontal outcomes, current pregnancy or lactation, recent antibiotics or professional periodontal treatment, or ongoing orthodontic treatment are unlikely to benefit from the results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized non-inferiority interventional trial comparing an optimal oral care regimen built around an intelligent electric toothbrush (i-Brush) and Oral‑B app to the same regimen plus professional mechanical plaque removal (PMPR) or a sham PMPR. Eligible adults (18–65 years) with gingivitis or stage I/localized stage II periodontitis and more than 20 teeth are randomized to receive the i‑Brush regimen alone or combined with PMPR, with clinicians measuring changes in gingival inflammation over the follow‑up period. The protocol includes oral hygiene instruction, standardized toothpaste use, and monitoring via the connected toothbrush/app to track adherence and brushing performance. Primary outcomes focus on gingival inflammation metrics to determine whether the i‑Brush regimen is non‑inferior to adding PMPR.
Why it matters
Potential benefit: If successful, this approach could reduce the need for routine professional cleanings, making effective gum care more accessible and lowering costs for large populations.
How similar studies have gone: Previous smaller studies have shown that intelligent toothbrush–based regimens can improve oral hygiene adherence and reduce plaque, but non‑inferiority versus PMPR has not been established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Maurizio Tonetti, DMD Phd — Shanghai PerioImplant Innovation Center, Ninth People Hospital
- Study coordinator: Rui Gao, Phd
- Email: gr1015209095@163.com
- Phone: 19818987186
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.