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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07549347
Enrollment
92
Registered
2026-04-24
Start date
2026-03-09
Completion date
2027-03-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Periodontitis

Keywords

artificial intelligence, internet of things network, oral hygiene instruction, professional mechanical plaque removal, mobile health

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.

Detailed description

Periodontitis is highly prevalent and develops from gingivitis caused by plaque accumulation. Managing gingivitis is the "best-buy" approach for preventing periodontitis and avoiding its local and systemic sequelae. Professional mechanical plaque removal (PMPR), which aims at removing plaque biofilm and dental calculus, is generally considered effective in treating gingivitis when provided in the context of oral hygiene instructions. However, delivering PMPR to large populations such as the Chinese population poses formidable challenges, including the formation of an adequate workforce. Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. However, many studies have shown poor patient compliance with routine oral hygiene instruction. A new technology based on an intelligent electric toothbrush (i-Brush) and the Internet of Things shows good application prospects. A previous study has verified the effectiveness of optimal oral care regimens, which involve the use of an i-brush and the application of standard toothpaste, in enhancing the adherence and performance of self-performed oral hygiene, leading to significant savings and a more effective allocation of healthcare resources. However, it is unclear whether PMPR still plays an important role when combined with such optimal oral care regimens in managing gingivitis and early-stage periodontitis. This study aims to determine whether the effect of the optimal oral care regimen in improving gingival inflammation in gingivitis and stage I periodontitis is not inferior to the effect of the combination with PMPR.

Interventions

BEHAVIORALOptimal 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.

DEVICEPeriodontal Treatment

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

DEVICESham 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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Statistician and laboratory test assessors will also be masked

Intervention model description

Non-inferiority study. If the non-inferiority hypothesis is rejected, a prespecified secondary analysis will be performed, stratifying by dental calculus status as a major prognostic factor.

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
changes in full mouth bleeding score (FMBS)from baseline to 6 monthschanges of full mouth bleeding score after periodontal treatment

Secondary

MeasureTime frameDescription
changes in probing depth (PD)from baseline to 6 monthschanges of probing depth after periodontal treatment
changes in plaque index (PI)from baseline to 6 monthschanges of plaque index after periodontal treatment
changes in calculus surface index (CSI)from baseline to 6 monthschanges of calculus surface index after periodontal treatment
changes in oral biomarker concentrationfrom baseline to 6 monthschanges of biomarker concentration (ng/ml) in saliva and oral rinse after periodontal treatment
changes in subgingival plaque taxafrom baseline to 6 monthschanges of the taxa of subgingival plaque after periodontal treatment
changes in patient reported outcomesfrom baseline to 6 monthschanges of patient reported outcomes evaluated by Oral Health Impact Profile-14 questionnaire after periodontal treatment

Countries

China

Contacts

CONTACTRui Gao, Phd
gr1015209095@163.com19818987186
CONTACTMaurizio Tonetti, DMD Phd
maurizio.tonetti@ergoperio.eu15000102368
PRINCIPAL_INVESTIGATORMaurizio Tonetti, DMD Phd

Shanghai PerioImplant Innovation Center, Ninth People Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026