GingivitisNCT07549347
Is Professional Tooth Cleaning Necessary for Managing Gingivitis (Gingival Inflammation) if Subjects Use Intelligent Toothbrushes?
A study testing Optimal oral care regimen and Periodontal Treatment in people with Gingivitis and Periodontitis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Gingivitis, Periodontitis
- What is being tested?
- Optimal oral care regimen and Periodontal Treatment
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≧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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Rui Gao, BDS, MSc, 8615000102368, gr1015209095@163.com
MAurizio Tonetti, DMD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingivitis, Periodontitis
- Being tested
- Optimal oral care regimen, Periodontal Treatment, Sham Periodontal Treatment
- Keywords
- artificial intelligence, internet of things network, oral hygiene instruction, professional mechanical plaque removal, mobile health
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal oral care regimenBehavioural
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 TreatmentDevice
At baseline, the control group will receive standard professional mechanical plaque removal consisting of supra - and subgingival debridement using ultrasonic device.
Sham Periodontal TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Optimal oral care regimen; Device: Periodontal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in full mouth bleeding score (FMBS)
changes of full mouth bleeding score after periodontal treatment
Measured: from baseline to 6 months
Secondary outcomes (6)
changes in probing depth (PD)
changes of probing depth after periodontal treatment
Measured: from baseline to 6 months
changes in plaque index (PI)
changes of plaque index after periodontal treatment
Measured: from baseline to 6 months
changes in calculus surface index (CSI)
changes of calculus surface index after periodontal treatment
Measured: from baseline to 6 months
changes in oral biomarker concentration
changes of biomarker concentration (ng/ml) in saliva and oral rinse after periodontal treatment
Measured: from baseline to 6 months
changes in subgingival plaque taxa
changes of the taxa of subgingival plaque after periodontal treatment
Measured: from baseline to 6 months
changes in patient reported outcomes
changes of patient reported outcomes evaluated by Oral Health Impact Profile-14 questionnaire after periodontal treatment
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start9 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Maurizio Tonetti, DMD Phd, Principal investigator, Shanghai PerioImplant Innovation Center, Ninth People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549347
- Sponsor's protocol ID
- ibrush-2026-1
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38631679Tonetti 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.
PubMed 32748486Sanz 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.
PubMed 32383274Tonetti 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.
PubMed 29926495
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Oral Care Regimen With or Without Professional Mechanical Plaque Removal in Managing Gingivitis (Gingival Inflammation): A Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07549347
- Acronym / sponsor ID
- ibrush-2026-1
- Conditions
- Gingivitis, Periodontitis
- Keywords
- artificial intelligence, internet of things network, oral hygiene instruction, professional mechanical plaque removal, mobile health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Behavioral: Optimal oral care regimen, Device: Sham Periodontal TreatmentThe 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. |
| Control group | Other | Behavioral: Optimal oral care regimen, Device: Periodontal TreatmentThe control group will receive standard Professional Mechanical Plaque Removal consisting of supra- and subgingival debridement at baseline. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ≧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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal oral care regimenBoth 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. | Behavioural | Control group, Test group |
| Periodontal TreatmentAt baseline, the control group will receive standard professional mechanical plaque removal consisting of supra - and subgingival debridement using ultrasonic device. | Device | Control group |
| Sham Periodontal TreatmentAt 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. | Device | Test group |
Primary outcome
changes in full mouth bleeding score (FMBS)
Time frame: from baseline to 6 months
changes of full mouth bleeding score after periodontal treatment
6 secondary outcomes
changes in probing depth (PD)
Time frame: from baseline to 6 months
changes in plaque index (PI)
Time frame: from baseline to 6 months
changes in calculus surface index (CSI)
Time frame: from baseline to 6 months
changes in oral biomarker concentration
Time frame: from baseline to 6 months
changes in subgingival plaque taxa
Time frame: from baseline to 6 months
changes in patient reported outcomes
Time frame: from baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 38631679Li 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.
- Background: PubMed 32748486Tonetti 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.
- Background: PubMed 32383274Sanz 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.
- Background: PubMed 29926495Tonetti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maurizio Tonetti, DMD Phd principal investigator
Shanghai PerioImplant Innovation Center, Ninth People Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal oral care regimen and Periodontal Treatment in people with Gingivitis and Periodontitis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Gao, Phd (19818987186, gr1015209095@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in full mouth bleeding score (FMBS) (time frame: from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549347, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.