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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≧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

Disqualifiers

Presence of any systemic disease that can alter the outcome of periodontal treatment

Pregnancy or lactation during the study

Having received antibiotics within the previous 3 months

Having received professional periodontal treatment within the previous 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Optimal oral care regimen

    Behavioral

    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.

  • Periodontal Treatment

    Device

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

  • Sham Periodontal Treatment

    Device

    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.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Test groupExperimental treatment 2 interventions
Group B: Control groupOther 2 interventions

Trial outcomes

Primary outcomes

1

changes in full mouth bleeding score (FMBS)

changes of full mouth bleeding score after periodontal treatment

Time frame
from baseline to 6 months

Secondary outcomes

1

changes in probing depth (PD)

changes of probing depth after periodontal treatment

Time frame
from baseline to 6 months
2

changes in plaque index (PI)

changes of plaque index after periodontal treatment

Time frame
from baseline to 6 months
3

changes in calculus surface index (CSI)

changes of calculus surface index after periodontal treatment

Time frame
from baseline to 6 months
4

changes in oral biomarker concentration

changes of biomarker concentration (ng/ml) in saliva and oral rinse after periodontal treatment

Time frame
from baseline to 6 months

Other outcomes

Sponsors and contacts

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