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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Plaque Induced Gingivitis; Toothbrushing; Compliance
• Intervention / Treatment: Device: Manual toothbrush; Device: Electric toothbrush; Device: AI toothbrush

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 Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Buthaina Firas Faisal, BDS; Phone Number: +964 7724597036; Email: buthaina.abd2405@codental.uobaghdad.edu.iq

Study Locations

• Iraq
  • Al-Rasafa
    • Baghdad, Al-Rasafa, Iraq, 1011
      • College of Dentistry, University of Baghdad
      • Contact: Ali Abbas Abdulkareem; Phone Number: +9647806866717; Email: ali.abbas@codental.uobaghdad.edu.iq
      • Principal Investigator: Buthaina Firas Faisal, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual toothbrush	Device: Manual toothbrush; Manual toothbrush used as a gold standard control
Active Comparator: Electric toothbrush	Device: Electric toothbrush; Electric toothbrush as a second control group
Experimental: AI-based toothbrush	Device: AI toothbrush; Smart toothbrush supported with AI applications to improve toothbrushing experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This index will be recorded at baseline, after 2 weeks, and 2 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	Plaque samples will be collected for analysis at baseline, 2 weeks, and 2 months

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Patient Compliance
• Other Study ID Numbers: 1120625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No