Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07549347

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

MAurizio Tonetti, DMD PhD

PRINCIPAL_INVESTIGATOR

Rui Gao, BDS, MSc

CONTACT

[email protected]

8615000102368

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≧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

Exclusion criteria

  • 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
  • With ongoing orthodontic treatment

Treatment and study plan

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.

Primary outcomes

  1. changes in full mouth bleeding score (FMBS)

    Time frame: from baseline to 6 months

    changes of full mouth bleeding score after periodontal treatment

Secondary outcomes

  1. changes in probing depth (PD)

    Time frame: from baseline to 6 months

    changes of probing depth after periodontal treatment

  2. changes in plaque index (PI)

    Time frame: from baseline to 6 months

    changes of plaque index after periodontal treatment

  3. changes in calculus surface index (CSI)

    Time frame: from baseline to 6 months

    changes of calculus surface index after periodontal treatment

  4. changes in oral biomarker concentration

    Time frame: from baseline to 6 months

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

  5. changes in subgingival plaque taxa

    Time frame: from baseline to 6 months

    changes of the taxa of subgingival plaque after periodontal treatment

  6. changes in patient reported outcomes

    Time frame: from baseline to 6 months

    changes of patient reported outcomes evaluated by Oral Health Impact Profile-14 questionnaire after periodontal treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Maurizio Tonetti, DMD Phd

CONTACT

[email protected]

15000102368

Rui Gao, Phd

CONTACT

[email protected]

19818987186

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.