Clinical ,Microbiological and Compliance Outcomes of AI-based Toothbrushes in Plaque Induced Gingivitis

NCT ID: NCT07308522

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-06-30

Brief 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. 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.

Conditions

Plaque Induced Gingivitis; Toothbrushing; Compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Manual toothbrush

Group Type: ACTIVE_COMPARATOR

Manual toothbrush

Intervention Type: DEVICE

Manual toothbrush used as a gold standard control

Electric toothbrush

Group Type: ACTIVE_COMPARATOR

Electric toothbrush

Intervention Type: DEVICE

Electric toothbrush as a second control group

AI-based toothbrush

Group Type: EXPERIMENTAL

AI toothbrush

Intervention Type: DEVICE

Smart toothbrush supported with AI applications to improve toothbrushing experience

Interventions

AI toothbrush

Smart toothbrush supported with AI applications to improve toothbrushing experience

Intervention Type: DEVICE

Manual toothbrush

Manual toothbrush used as a gold standard control

Intervention Type: DEVICE

Electric toothbrush

Electric toothbrush as a second control group

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Individuals who smoke or alcoholism.
• Pregnant, breastfeeding women or those using contraceptive tablets.
• Individuals with orthodontic devices or removable dentures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Buthaina Firas Faisal

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

College of Dentistry, University of Baghdad

Baghdad, Al-Rasafa, Iraq

Countries

Iraq

Central Contacts

Buthaina Firas Faisal, BDS

Role: CONTACT

Phone: +964 7724597036

Email: buthaina.abd2405@codental.uobaghdad.edu.iq

Facility Contacts

Ali Abbas Abdulkareem

Role: primary

Other Identifiers

1120625

Identifier Type: -

Identifier Source: org_study_id