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

NCT07308522 | Not Yet Recruiting

• 1 other identifier: 1120625
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Induced Gingivitis; Toothbrushing; Compliance

Outcome Measures

Primary Outcomes (1)

• Plaque index

  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.

  This index will be recorded at baseline, after 2 weeks, and 2 months after enrollment

Secondary Outcomes (3)

• Modified sulcular bleeding index

  The index will be recorded at baseline, 2 weeks, and 2 months after enrolment

• Compliance to oral hygiene instructions and level of satisfaction

  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

  Plaque samples will be collected for analysis at baseline, 2 weeks, and 2 months

Study Arms (3)

Manual toothbrush

ACTIVE COMPARATOR

Device: Manual toothbrush

Electric toothbrush

ACTIVE COMPARATOR

Device: Electric toothbrush

AI-based toothbrush

EXPERIMENTAL

Device: AI toothbrush

Interventions

AI toothbrush DEVICE

Smart toothbrush supported with AI applications to improve toothbrushing experience

AI-based toothbrush

Manual toothbrush DEVICE

Manual toothbrush used as a gold standard control

Manual toothbrush

Electric toothbrush DEVICE

Electric toothbrush as a second control group

Electric toothbrush

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants should be systemically healthy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, Al-Rasafa, 1011, Iraq

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Buthaina Firas Faisal, BDS

CONTACT

+964 7724597036; buthaina.abd2405@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)