Plaque Induced GingivitisNCT07308522
Clinical ,Microbiological and Compliance Outcomes of AI-based Toothbrushes in Plaque Induced Gingivitis
A study testing AI toothbrush, Manual toothbrush and Electric toothbrush in people with Plaque Induced Gingivitis and Toothbrushing, run by University of Baghdad at 1 site in Iraq.
Trial summary
Severe periodontitis is widespread and begins with reversible gingivitis, driven by poor oral hygiene and a dysbiotic microbiome. Daily toothbrushing is the simplest prevention, but patients still leave plaque. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Plaque Induced Gingivitis, Toothbrushing, Compliance
- What is being tested?
- AI toothbrush, Manual toothbrush and Electric toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2026to 30 Jun 2026
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants should be systemically healthy
- 18 years old, with the presence of ≥ 20 teeth
- Diagnosed with generalized plaque-induced gingivitis having >30% bleeding sites, with probing depths ≤3 mm and intact periodontium
- Participants with at least secondary school education, who are able to read and understand basic English to follow the app-based toothbrush instructions
Who cannot join
- Participants who using antibiotics or anti-inflammatory medication throughout the investigation or during the previous 3 months prior to the study.
- Drug-induced gingival enlargement (phenytoin, cyclosporine, calciumchannel blockers).
- Individuals with periodontitis and healthy periodontium.
- Mouth breathers .
- Individuals with severe dental crowding or malalignment that prevents proper toothbrushing.
- Individuals with heavy calculus.
Show all 9Show fewer
- Individuals who smoke or alcoholism.
- Pregnant, breastfeeding women or those using contraceptive tablets.
- Individuals with orthodontic devices or removable dentures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
College of Dentistry, University of Baghdad
Baghdad, Al-Rasafa, 1011
Ali Abbas Abdulkareem, +9647806866717, ali.abbas@codental.uobaghdad.edu.iq
Buthaina Firas Faisal, BDS
About this study
Official title: Clinical ,Microbiological and Compliance Outcomes of AI-based vs Standard Electric and Manual Toothbrushes in Adults With Plaque-Induced Gingivitis: A 6-Week Randomized Controlled Trial
Severe periodontitis is widespread and begins with reversible gingivitis, driven by poor oral hygiene and a dysbiotic microbiome. Daily toothbrushing is the simplest prevention, but patients still leave plaque. Electric brushes remove more plaque and reduce gingivitis better than manual ones, and users show better periodontal status. App-connected smart brushes and apps aim to improve adherence. Trials increased plaque reduction and brushing time versus manual brushing, but app layers have not clearly beaten standard power brushes, and microbiological outcomes are rarely reported. Xiaomi's AI-based sonic T501 adds pressure sensing, personalised coaching and coverage tracking, whereas the T302 is a simpler non-connected sonic brush. Streptococcus sanguinis is a health-associated early coloniser; its qPCR-measured relative abundance marks a healthy supragingival profile. It is still unclear whether AI guidance adds extra benefit beyond a standard electric brush in adult gingivitis.
Read the detailed description
Worldwide, 538 million people are reported to have severe periodontitis .The root of this problem lies in its initial stage, gingivitis. Gingivitis typically results from inadequate oral hygiene, which can quickly shift a healthy oral microbiome to a dysbiotic state, leading to gingival inflammation and bleeding. If this early stage is not treated, more advanced periodontal disease can occur with irreversible oral health consequences and systemic implications.
Among the simplest and most cost-effective approaches for preventing periodontal disease is daily self-care. Effective toothbrushing mechanically removes plaque, reverses gingivitis, and prevents its inception.The better plaque is controlled, the more substantial the clinical gains. However, even with their best efforts, patients often leave considerable amounts of plaque behind after toothbrushing .
Various toothbrush designs and technologies have been developed to improve plaque removal. Results of systematic reviews and meta-analyses evaluating these options consistently showed electric toothbrushes provide significantly greater plaque removal and gingivitis control than manual toothbrushes. These benefits have been corroborated by the results of population-based research showing poorer periodontal health status and fewer teeth present for manual toothbrush users than electric toothbrush users. AI in dentistry uses machine-learning tools to assist clinicians detecting disease on radiographs, supporting diagnosis/risk assessment (e.g., caries/periodontitis), optimizing treatment planning/CAD-CAM, and boosting patient adherence via smart, sensor-based brushes and apps. In early app-connected trials, adolescents used a manual brush and an interactive, Bluetooth-enabled oscillating-rotating brush + app. The app-connected brush significantly increased whole-mouth plaque reduction and brushing time in a 2-week single-blind RCT .
Another was a three-arm, eight-week RCT that compared a manual brush to the same power brush with or without app assistance in dental students with gingivitis.
For plaque and bleeding, both powered brushes performed better than the manual; however, in that sample, the app layer did not provide a definite clinical advantage over the non-app powered brush . Recently, a smart sonic toothbrush (Xiaomi T501) has been introduced that combines a magnetic-levitation motor with motion/pressure sensing and app-based coaching. The motor generates high-frequency micro-vibrations that transmit energy to the bristle tips while the built-in pressure sensor limits excessive force.
Through Bluetooth, the brush can provide real-time timers, quadrant pacing, and zone-coverage feedback in the Xiaomi Home app. In addition, an AI-adjustment module analyzes inertial-sensor and pressure data from prior sessions to personalize guidance, highlighting under-cleaned zones, recommending softer intensity after repeated over-pressure events. Standard electric brush (Xiaomi T302) a non-connected sonic toothbrush with a low-noise brushless motor and 4 cleaning modes. It includes a built-in 2-minute timer with 30-second pacing to cue quadrant changes. The device has no Bluetooth/app (no AI guidance) and no pressure-sensor. Microbiologically, in periodontal health, supragingival plaque is dominated by early colonizing streptococci (e.g., Streptococcus sanguinis, S. mitis, S. gordonii) that form part of the health-associated "yellow/green" groups .
With plaque accumulation , communities follow a reproducible succession:
biomass increases and the microbiota shifts toward more anaerobic, proteolytic taxa (e.g., Fusobacterium, Prevotella), paralleling clinical inflammation . Streptococcus sanguinis is a key health-associated commensal and early enamel colonizer; its presence correlates with clinically healthy plaque and caries- resistance. During gingivitis development, S. sanguinis often decreases as more anaerobic species expand, so we will quantify its relative abundance by qPCR as a marker of a health-associated supragingival profile, reported alongside clinical indices. Evidence gap : Existing app-connected toothbrush trials are mostly comparing powered+app to manual brushing, so they do not isolate whether modern AI-based guidance adds benefit beyond a standard electric brush in adult gingivitis patients . Microbiological endpoints reported in parallel with clinical outcomes are rarely included.
- Conditions
- Plaque Induced Gingivitis, Toothbrushing, Compliance
- Being tested
- AI toothbrush, Manual toothbrush, Electric toothbrush
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI toothbrushDevice
Smart toothbrush supported with AI applications to improve toothbrushing experience
Manual toothbrushDevice
Manual toothbrush used as a gold standard control
Electric toothbrushDevice
Electric toothbrush as a second control group
| Study group | Role | What they receive |
|---|---|---|
| Manual toothbrush | Active comparator | Not described Receives: Device: Manual toothbrush |
| Electric toothbrush | Active comparator | Not described Receives: Device: Electric toothbrush |
| AI-based toothbrush | Experimental | Not described Receives: Device: AI toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Turesky-modified Quigley-Hein Plaque Index will be quantified on a scale between 0 to 5:
0 No plaque
- Isolated areas of plaque at the cervical margin of the tooth.
- A thin continuous band of plaque (up to 1 mm) at cervical margin of tooth.
- A band of plaque wider than 1 mm but covering less than one- third of the crown of the tooth.
- Plaque covering at least one-third but less than two-thirds of the crown of the tooth.
- plaque covering two-thirds or more of the crown of the tooth.
Measured: This index will be recorded at baseline, after 2 weeks, and 2 months after enrollment
Secondary outcomes (3)
Modified sulcular bleeding index
Bleeding after probing gingival sulcus will be scored as follows:
Score 0: No bleeding. Score 1: Isolated spots bleeding. Score 2: Blood forms a confluent red line or margin. Score 3: Heavy or profuse bleeding
Measured: The index will be recorded at baseline, 2 weeks, and 2 months after enrolment
Compliance to oral hygiene instructions and level of satisfaction
Degree of compliance and patient-reported outcome about satisfaction level after using different types of toothbrushes using a questionnaire
Measured: The compliance will be assessed after 2 week and 2 months. Satisfaction will be assessed at the endpoint of the study (2 months)
Microbiological analysis
Relative abundance of Streptococcus Sanguinis in supragingival plaque samples will be measured using PCR technique.
Measured: Plaque samples will be collected for analysis at baseline, 2 weeks, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced GingivitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buthaina Firas Faisal, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308522
- Sponsor's protocol ID
- 1120625
- Status last verified
- Nov 2025
- First submitted
- 13 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD relevant to study results will be shared. Other personal information such as full names, phone number, location, marital status, and income level will not be shared for confidentiality reasons.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical ,Microbiological and Compliance Outcomes of AI-based vs Standard Electric and Manual Toothbrushes in Adults With Plaque-Induced Gingivitis: A 6-Week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07308522
- Acronym / sponsor ID
- 1120625
- Conditions
- Plaque Induced Gingivitis, Toothbrushing, Compliance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
Severe periodontitis is widespread and begins with reversible gingivitis, driven by poor oral hygiene and a dysbiotic microbiome. Daily toothbrushing is the simplest prevention, but patients still leave plaque. Electric brushes remove more plaque and reduce gingivitis better than manual ones, and users show better periodontal status. App-connected smart brushes and apps aim to improve adherence. Trials increased plaque reduction and brushing time versus manual brushing, but app layers have not clearly beaten standard power brushes, and microbiological outcomes are rarely reported. Xiaomi's AI-based sonic T501 adds pressure sensing, personalised coaching and coverage tracking, whereas the T302 is a simpler non-connected sonic brush. Streptococcus sanguinis is a health-associated early coloniser; its qPCR-measured relative abundance marks a healthy supragingival profile. It is still unclear whether AI guidance adds extra benefit beyond a standard electric brush in adult gingivitis.
Detailed description
Worldwide, 538 million people are reported to have severe periodontitis .The root of this problem lies in its initial stage, gingivitis. Gingivitis typically results from inadequate oral hygiene, which can quickly shift a healthy oral microbiome to a dysbiotic state, leading to gingival inflammation and bleeding. If this early stage is not treated, more advanced periodontal disease can occur with irreversible oral health consequences and systemic implications.
Among the simplest and most cost-effective approaches for preventing periodontal disease is daily self-care. Effective toothbrushing mechanically removes plaque, reverses gingivitis, and prevents its inception.The better plaque is controlled, the more substantial the clinical gains. However, even with their best efforts, patients often leave considerable amounts of plaque behind after toothbrushing .
Various toothbrush designs and technologies have been developed to improve plaque removal. Results of systematic reviews and meta-analyses evaluating these options consistently showed electric toothbrushes provide significantly greater plaque removal and gingivitis control than manual toothbrushes. These benefits have been corroborated by the results of population-based research showing poorer periodontal health status and fewer teeth present for manual toothbrush users than electric toothbrush users. AI in dentistry uses machine-learning tools to assist clinicians detecting disease on radiographs, supporting diagnosis/risk assessment (e.g., caries/periodontitis), optimizing treatment planning/CAD-CAM, and boosting patient adherence via smart, sensor-based brushes and apps. In early app-connected trials, adolescents used a manual brush and an interactive, Bluetooth-enabled oscillating-rotating brush + app. The app-connected brush significantly increased whole-mouth plaque reduction and brushing time in a 2-week single-blind RCT .
Another was a three-arm, eight-week RCT that compared a manual brush to the same power brush with or without app assistance in dental students with gingivitis.
For plaque and bleeding, both powered brushes performed better than the manual; however, in that sample, the app layer did not provide a definite clinical advantage over the non-app powered brush . Recently, a smart sonic toothbrush (Xiaomi T501) has been introduced that combines a magnetic-levitation motor with motion/pressure sensing and app-based coaching. The motor generates high-frequency micro-vibrations that transmit energy to the bristle tips while the built-in pressure sensor limits excessive force.
Through Bluetooth, the brush can provide real-time timers, quadrant pacing, and zone-coverage feedback in the Xiaomi Home app. In addition, an AI-adjustment module analyzes inertial-sensor and pressure data from prior sessions to personalize guidance, highlighting under-cleaned zones, recommending softer intensity after repeated over-pressure events. Standard electric brush (Xiaomi T302) a non-connected sonic toothbrush with a low-noise brushless motor and 4 cleaning modes. It includes a built-in 2-minute timer with 30-second pacing to cue quadrant changes. The device has no Bluetooth/app (no AI guidance) and no pressure-sensor. Microbiologically, in periodontal health, supragingival plaque is dominated by early colonizing streptococci (e.g., Streptococcus sanguinis, S. mitis, S. gordonii) that form part of the health-associated "yellow/green" groups .
With plaque accumulation , communities follow a reproducible succession:
biomass increases and the microbiota shifts toward more anaerobic, proteolytic taxa (e.g., Fusobacterium, Prevotella), paralleling clinical inflammation . Streptococcus sanguinis is a key health-associated commensal and early enamel colonizer; its presence correlates with clinically healthy plaque and caries- resistance. During gingivitis development, S. sanguinis often decreases as more anaerobic species expand, so we will quantify its relative abundance by qPCR as a marker of a health-associated supragingival profile, reported alongside clinical indices. Evidence gap : Existing app-connected toothbrush trials are mostly comparing powered+app to manual brushing, so they do not isolate whether modern AI-based guidance adds benefit beyond a standard electric brush in adult gingivitis patients . Microbiological endpoints reported in parallel with clinical outcomes are rarely included.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual toothbrush | Active comparator | Device: Manual toothbrush |
| Electric toothbrush | Active comparator | Device: Electric toothbrush |
| AI-based toothbrush | Experimental | Device: AI toothbrush |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants should be systemically healthy
- 18 years old, with the presence of ≥ 20 teeth
- Diagnosed with generalized plaque-induced gingivitis having >30% bleeding sites, with probing depths ≤3 mm and intact periodontium
- Participants with at least secondary school education, who are able to read and understand basic English to follow the app-based toothbrush instructions
Key exclusion criteria (9 listed)
- Participants who using antibiotics or anti-inflammatory medication throughout the investigation or during the previous 3 months prior to the study.
- Drug-induced gingival enlargement (phenytoin, cyclosporine, calciumchannel blockers).
- Individuals with periodontitis and healthy periodontium.
- Mouth breathers .
- Individuals with severe dental crowding or malalignment that prevents proper toothbrushing.
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 |
|---|---|---|
| AI toothbrushSmart toothbrush supported with AI applications to improve toothbrushing experience | Device | AI-based toothbrush |
| Manual toothbrushManual toothbrush used as a gold standard control | Device | Manual toothbrush |
| Electric toothbrushElectric toothbrush as a second control group | Device | Electric toothbrush |
Primary outcome
Plaque index
Time frame: This index will be recorded at baseline, after 2 weeks, and 2 months after enrollment
Turesky-modified Quigley-Hein Plaque Index will be quantified on a scale between 0 to 5: 0 No plaque 1. Isolated areas of plaque at the cervical margin of the tooth. 2. A thin continuous band of plaque (up to 1 mm) at cervical margin of tooth. 3. A band of plaque wider than 1 mm but covering less than one- third of the crown of the tooth. 4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth. 5. plaque covering two-thirds or more of the crown of the tooth.
3 secondary outcomes
Modified sulcular bleeding index
Time frame: The index will be recorded at baseline, 2 weeks, and 2 months after enrolment
Compliance to oral hygiene instructions and level of satisfaction
Time frame: The compliance will be assessed after 2 week and 2 months. Satisfaction will be assessed at the endpoint of the study (2 months)
Microbiological analysis
Time frame: Plaque samples will be collected for analysis at baseline, 2 weeks, and 2 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 29 Dec 2025.
- Individual participant dataSharing planned: Yes. Only IPD relevant to study results will be shared. Other personal information such as full names, phone number, location, marital status, and income level will not be shared for confidentiality reasons.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI toothbrush, Manual toothbrush and Electric toothbrush in people with Plaque Induced Gingivitis and Toothbrushing, run by University of Baghdad at 1 site in Iraq.
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: opening soon, as of the sponsor's last update on 29 Dec 2025. 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 Iraq. 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 Buthaina Firas Faisal, BDS (+964 7724597036, buthaina.abd2405@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (time frame: This index will be recorded at baseline, after 2 weeks, and 2 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.