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

NCT07549347 | Recruiting

• 1 other identifier: ibrush-2026-1
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• changes in full mouth bleeding score (FMBS)

  changes of full mouth bleeding score after periodontal treatment

  from baseline to 6 months

Secondary Outcomes (6)

• changes in probing depth (PD)

  from baseline to 6 months

• changes in plaque index (PI)

  from baseline to 6 months

• changes in calculus surface index (CSI)

  from baseline to 6 months

• changes in oral biomarker concentration

  from baseline to 6 months

• changes in subgingival plaque taxa

  from baseline to 6 months

Study Arms (2)

Test group

EXPERIMENTAL

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; Device: Sham Periodontal Treatment

Control group

OTHER

The control group will receive standard Professional Mechanical Plaque Removal consisting of supra- and subgingival debridement at baseline.

Behavioral: Optimal oral care regimen; Device: Periodontal Treatment

Interventions

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.

Control group; Test group

Periodontal Treatment DEVICE

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

Control group

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.

Test group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≧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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (4)

• Li Y, Wu X, Liu M, Deng K, Tullini A, Zhang X, Shi J, Lai H, Tonetti MS. Enhanced control of periodontitis by an artificial intelligence-enabled multimodal-sensing toothbrush and targeted mHealth micromessages: A randomized trial. J Clin Periodontol. 2024 Dec;51(12):1632-1643. doi: 10.1111/jcpe.13987. Epub 2024 Apr 17.

  PMID: 38631679 BACKGROUND

• Tonetti MS, Deng K, Christiansen A, Bogetti K, Nicora C, Thurnay S, Cortellini P. Self-reported bleeding on brushing as a predictor of bleeding on probing: Early observations from the deployment of an internet of things network of intelligent power-driven toothbrushes in a supportive periodontal care population. J Clin Periodontol. 2020 Oct;47(10):1219-1226. doi: 10.1111/jcpe.13351. Epub 2020 Aug 31.

  PMID: 32748486 BACKGROUND

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 BACKGROUND

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.

  PMID: 29926495 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Periodontitis

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Maurizio Tonetti, DMD Phd

  Shanghai PerioImplant Innovation Center, Ninth People Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Gao, Phd

CONTACT

19818987186; gr1015209095@163.com

Maurizio Tonetti, DMD Phd

CONTACT

15000102368; maurizio.tonetti@ergoperio.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician and laboratory test assessors will also be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: April 24, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)