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

April 17, 2026 updated by: Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • MAurizio Tonetti, DMD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
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 at baseline.
Behavioral: Optimal 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.
Device: Sham 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.
Other: Control group
The control group will receive standard Professional Mechanical Plaque Removal consisting of supra- and subgingival debridement at baseline.
Behavioral: Optimal 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.
Device: Periodontal Treatment
At baseline, the control group will receive standard professional mechanical plaque removal consisting of supra - and subgingival debridement using ultrasonic device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in full mouth bleeding score (FMBS)
Time Frame: from baseline to 6 months
changes of full mouth bleeding score after periodontal treatment
from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in probing depth (PD)
Time Frame: from baseline to 6 months
changes of probing depth after periodontal treatment
from baseline to 6 months
changes in plaque index (PI)
Time Frame: from baseline to 6 months
changes of plaque index after periodontal treatment
from baseline to 6 months
changes in calculus surface index (CSI)
Time Frame: from baseline to 6 months
changes of calculus surface index after periodontal treatment
from baseline to 6 months
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
from baseline to 6 months
changes in subgingival plaque taxa
Time Frame: from baseline to 6 months
changes of the taxa of subgingival plaque after periodontal treatment
from baseline to 6 months
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
from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Maurizio Tonetti, DMD Phd, Shanghai PerioImplant Innovation Center, Ninth People Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ibrush-2026-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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