PeriodontitisNCT05137392
Effect of Novel Oral Hygiene Regimen on Non-surgical Treatment of Stage II and III Periodontitis
A study testing oral hygiene instruction in people with Periodontitis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. The improvement of the patient's adherence to good oral hygiene is of great importance to obtain the satisfactory treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- oral hygiene instruction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 and above
- Generalized Stage II and Stage III periodontitis
- Subjects willing to receive NSPT necessary for the management of periodontitis and to comply with research appointments/schedule
- Use of a compatible Android cell phone with Oral-B 8.5.1 Application
Who cannot join
- Edentulism
- Presence of any systemic disease that can alter the manifestation/outcome of periodontal treatment
- Pregnancy or intention to become pregnant at any point during the study duration
- Having received antibiotics within the previous 3 months
- Need for antibiotic prophylaxis in the context of dental treatment
- Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
Show all 9Show fewer
- Presence of xerostomia interfering with saliva sampling
- Participation in another intervention trial
- Inability or unwillingness of individual to give written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai PerioImplant Innovation Center, Ninth People Hospital
Shanghai, Shanghai Municipality, 200125
About this study
Official title: Impact of Intensive Oral Hygiene Regimen Based on Individualized Messages and an Intelligent Power-driven Toothbrush on Non-surgical Treatment of Stage II and III Periodontitis: A Randomized, Standard of Care-controlled Trial
Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. The improvement of the patient's adherence to good oral hygiene is of great importance to obtain the satisfactory treatment outcomes. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New electric artificial intelligence powered toothbrushes are able to precisely sense the location of the brushing being performed by the patient and transmit information to the clinician who is able to analyze the data and provide targeted instructions, if needed. This study evaluates whether a novel oral hygiene instruction regimen can provide some additional benefit for periodontal treatment compared with routine oral hygiene instructions.
Read the detailed description
Dental plaque is causally linked to gingival inflammation and essential for the onset of periodontitis. The main goal of periodontal treatment is the establishment of adequate infection control to reduce the bacterial load below individual threshold levels of inflammation. Achievement of adequate oral hygiene standards is critical to effective periodontal therapy. Classical studies have shown that professional tooth cleaning during healing of subgingival debridement provides superior outcomes. Regrettably, costs do not allow routine implementation of these regimens. By far, patient-centred homecare is the most cost-effective approach to maintaining good oral hygiene. Therefore, improving the adherence with self-performed oral hygiene is a priority in periodontal practice.
Conventionally, clinicians provide oral hygiene instructions to the patients based on the results of their clinical examinations, sometimes supplemented with written information in brochure and disclosing agents to show the location of the biofilm. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New technology based on an internet of things network of intelligent toothbrushes (i-Brush) has shown excellent adherence of use in a pilot study in a maintenance population. Other studies have shown that electronic messaging and mobile health (mHealth) supported by smartphones and applications improve oral hygiene performance, particularly in younger individuals undergoing orthodontic treatment. New electric artificial intelligence powered toothbrushes are able to precisely sense the location of the brushing being performed by the patient and transmit information to the clinician who is able to analyze the data and provide targeted instructions, if needed. Remote sensing of oral hygiene practices through the connected intelligent powered toothbrush allows more specific and targeted messages, thereby promoting personalized oral health care and eventually improving the healing outcomes of periodontal therapy through a two-way communication between patients and clinicians. This study aims to investigate the clinical efficacy of a novel regimen consisting of a new generation of power-driven internet connected i-Brush and targeted m-Health messages in improving periodontal treatment outcomes in comparison with routine oral hygiene instructions.
- Conditions
- Periodontitis
- Being tested
- oral hygiene instruction
- Keywords
- mobile health, oral hygiene instruction, internet of things network, artificial intelligence
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral hygiene instructionOther
The treatment process is identical for both test and control groups except for the methods of oral hygiene instructions. In the control group, the participants will receive the following oral hygiene instructions at completion of debridement, at week-1 and week-3. In the test group, apart from the standard oral hygiene instructions at completion of debridement, at week-1 and week-3 , additional analysis of brushing data and provision of targeted brief interventions will be provided on a daily basis for the first week, 3 times/week until week 6 and once a week thereafter until 6 months after the debridement.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | The test group will receive the novel regimen of oral hygiene instruction, including use of a commercially available intelligent toothbrush connected to the Chinese consumer version of an application and receiving targeted oral health message as well as use of interdental toothbrush Receives: Other: oral hygiene instruction |
| Control group | Other | The test group will receive the standard regimen of oral hygiene instruction, including use of a commercially available manual toothbrush and receiving a brochure for oral hygiene instruction as well as use of interdental toothbrush Receives: Other: oral hygiene instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in probing pocket depth (PPD)
changes in probing pocket depth (PPD) after non-surgical periodontal treatment (NSPT)
Measured: from baseline to 6 months
changes in proportion of periodontal pocket closure
changes in proportion of periodontal pocket closure defined by probing pocket depth (PPD) ≤4mm without bleeding on probing (BOP) after non-surgical periodontal treatment (NSPT)
Measured: from baseline to 6 months
Secondary outcomes (6)
changes in clinical attachment level (CAL)
changes of clinical attachment level (CAL) after non-surgical periodontal treatment (NSPT)
Measured: from baseline to 6 months
changes in bleeding on probing (BOP)
changes in bleeding on probing (BOP) after non-surgical periodontal treatment (NSPT)
Measured: from baseline to 6 months
changes in periodontal soft tissue volumes
changes in periodontal soft tissue volumes or reduction of tissue edema after non-surgical periodontal treatment (NSPT)
Measured: from baseline to 6 months
changes in oral biomarker concentration
the changes in biomarker concentration in saliva and oral rinse after non-surgical periodontal treatment (NSPT)
Measured: from baseline to 6 months
changes in proportion of periodontal pocket closure
changes in proportion of periodontal pocket closure is defined by probing pocket depth (PPD) ≤4mm without bleeding on probing (BOP) after non-surgical periodontal treatment (NSPT)
Measured: from baseline to 3 months
changes in probing pocket depth (PPD)
changes in probing pocket depth (PPD) after non-surgical periodontal treatment (NSPT)
Measured: from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Feb 2022
- Primary completion1 Jul 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- 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 Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137392
- Sponsor's protocol ID
- iBrush0817
- Status last verified
- Oct 2023
- First submitted
- 3 Nov 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toniazzo MP, Nodari D, Muniz FWMG, Weidlich P. Effect of mHealth in improving oral hygiene: A systematic review with meta-analysis. J Clin Periodontol. 2019 Mar;46(3):297-309. doi: 10.1111/jcpe.13083.
PubMed 30761580Johansson LA, Oster B, Hamp SE. Evaluation of cause-related periodontal therapy and compliance with maintenance care recommendations. J Clin Periodontol. 1984 Nov;11(10):689-99. doi: 10.1111/j.1600-051x.1984.tb01317.x.
PubMed 6594355Suvan J, Leira Y, Moreno Sancho FM, Graziani F, Derks J, Tomasi C. Subgingival instrumentation for treatment of periodontitis. A systematic review. J Clin Periodontol. 2020 Jul;47 Suppl 22:155-175. doi: 10.1111/jcpe.13245.
PubMed 31889320Tonetti 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 32748486Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
PubMed 29926952Sanz 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 32383274Li 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 38631679
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intensive Oral Hygiene Regimen Based on Individualized Messages and an Intelligent Power-driven Toothbrush on Non-surgical Treatment of Stage II and III Periodontitis: A Randomized, Standard of Care-controlled Trial
- ClinicalTrials.gov ID
- NCT05137392
- Acronym / sponsor ID
- iBrush0817
- Conditions
- Periodontitis
- Keywords
- mobile health, oral hygiene instruction, internet of things network, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 30 Nov 2021 (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.
Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. The improvement of the patient's adherence to good oral hygiene is of great importance to obtain the satisfactory treatment outcomes. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New electric artificial intelligence powered toothbrushes are able to precisely sense the location of the brushing being performed by the patient and transmit information to the clinician who is able to analyze the data and provide targeted instructions, if needed. This study evaluates whether a novel oral hygiene instruction regimen can provide some additional benefit for periodontal treatment compared with routine oral hygiene instructions.
Detailed description
Dental plaque is causally linked to gingival inflammation and essential for the onset of periodontitis. The main goal of periodontal treatment is the establishment of adequate infection control to reduce the bacterial load below individual threshold levels of inflammation. Achievement of adequate oral hygiene standards is critical to effective periodontal therapy. Classical studies have shown that professional tooth cleaning during healing of subgingival debridement provides superior outcomes. Regrettably, costs do not allow routine implementation of these regimens. By far, patient-centred homecare is the most cost-effective approach to maintaining good oral hygiene. Therefore, improving the adherence with self-performed oral hygiene is a priority in periodontal practice.
Conventionally, clinicians provide oral hygiene instructions to the patients based on the results of their clinical examinations, sometimes supplemented with written information in brochure and disclosing agents to show the location of the biofilm. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New technology based on an internet of things network of intelligent toothbrushes (i-Brush) has shown excellent adherence of use in a pilot study in a maintenance population. Other studies have shown that electronic messaging and mobile health (mHealth) supported by smartphones and applications improve oral hygiene performance, particularly in younger individuals undergoing orthodontic treatment. New electric artificial intelligence powered toothbrushes are able to precisely sense the location of the brushing being performed by the patient and transmit information to the clinician who is able to analyze the data and provide targeted instructions, if needed. Remote sensing of oral hygiene practices through the connected intelligent powered toothbrush allows more specific and targeted messages, thereby promoting personalized oral health care and eventually improving the healing outcomes of periodontal therapy through a two-way communication between patients and clinicians. This study aims to investigate the clinical efficacy of a novel regimen consisting of a new generation of power-driven internet connected i-Brush and targeted m-Health messages in improving periodontal treatment outcomes in comparison with routine oral hygiene instructions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: oral hygiene instructionThe test group will receive the novel regimen of oral hygiene instruction, including use of a commercially available intelligent toothbrush connected to the Chinese consumer version of an application and receiving targeted oral health message as well as use of interdental toothbrush |
| Control group | Other | Other: oral hygiene instructionThe test group will receive the standard regimen of oral hygiene instruction, including use of a commercially available manual toothbrush and receiving a brochure for oral hygiene instruction as well as use of interdental toothbrush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 and above
- Generalized Stage II and Stage III periodontitis
- Subjects willing to receive NSPT necessary for the management of periodontitis and to comply with research appointments/schedule
- Use of a compatible Android cell phone with Oral-B 8.5.1 Application
Key exclusion criteria (9 listed)
- Edentulism
- Presence of any systemic disease that can alter the manifestation/outcome of periodontal treatment
- Pregnancy or intention to become pregnant at any point during the study duration
- Having received antibiotics within the previous 3 months
- Need for antibiotic prophylaxis in the context of dental 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 |
|---|---|---|
| oral hygiene instructionThe treatment process is identical for both test and control groups except for the methods of oral hygiene instructions. In the control group, the participants will receive the following oral hygiene instructions at completion of debridement, at week-1 and week-3. In the test group, apart from the standard oral hygiene instructions at completion of debridement, at week-1 and week-3 , additional analysis of brushing data and provision of targeted brief interventions will be provided on a daily basis for the first week, 3 times/week until week 6 and once a week thereafter until 6 months after the debridement. | Other | Control group, Test group |
Primary outcome
changes in probing pocket depth (PPD)
Time frame: from baseline to 6 months
changes in probing pocket depth (PPD) after non-surgical periodontal treatment (NSPT)
changes in proportion of periodontal pocket closure
Time frame: from baseline to 6 months
changes in proportion of periodontal pocket closure defined by probing pocket depth (PPD) ≤4mm without bleeding on probing (BOP) after non-surgical periodontal treatment (NSPT)
6 secondary outcomes
changes in clinical attachment level (CAL)
Time frame: from baseline to 6 months
changes in bleeding on probing (BOP)
Time frame: from baseline to 6 months
changes in periodontal soft tissue volumes
Time frame: from baseline to 6 months
changes in oral biomarker concentration
Time frame: from baseline to 6 months
changes in proportion of periodontal pocket closure
Time frame: from baseline to 3 months
changes in probing pocket depth (PPD)
Time frame: from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Results publication: PubMed 30761580Toniazzo MP, Nodari D, Muniz FWMG, Weidlich P. Effect of mHealth in improving oral hygiene: A systematic review with meta-analysis. J Clin Periodontol. 2019 Mar;46(3):297-309. doi: 10.1111/jcpe.13083.
- Results publication: PubMed 6594355Johansson LA, Oster B, Hamp SE. Evaluation of cause-related periodontal therapy and compliance with maintenance care recommendations. J Clin Periodontol. 1984 Nov;11(10):689-99. doi: 10.1111/j.1600-051x.1984.tb01317.x.
- Results publication: PubMed 31889320Suvan J, Leira Y, Moreno Sancho FM, Graziani F, Derks J, Tomasi C. Subgingival instrumentation for treatment of periodontitis. A systematic review. J Clin Periodontol. 2020 Jul;47 Suppl 22:155-175. doi: 10.1111/jcpe.13245.
- Results publication: 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.
- Results publication: PubMed 29926952Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
- Results publication: 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.
- Derived from this study: 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.
- 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. This study is not recruiting at the moment.
Maurizio Tonetti, DMD PhD principal investigator
Shanghai Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral hygiene instruction in people with 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 9 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: finished, as of the sponsor's last update on 25 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in probing pocket depth (PPD) (time frame: from baseline to 6 months). The study lists 2 primary outcomes in all. 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 NCT05137392, which also lists 7 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 25 Oct 2023.