Health TrialsbyHealthPanel

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

ConditionsPlaque Induced GingivitisToothbrushingCompliance
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversity of Baghdad

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 .

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI toothbrush

    Device

    Smart toothbrush supported with AI applications to improve toothbrushing experience

  • Manual toothbrush

    Device

    Manual toothbrush used as a gold standard control

  • Electric toothbrush

    Device

    Electric toothbrush as a second control group

Treatment groups

33 Participants
are divided into 3 treatment groups
Group A: Manual toothbrushActive comparator 1 intervention
Group B: Electric toothbrushActive comparator 1 intervention
Group C: AI-based toothbrushExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

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

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

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)
3

Microbiological analysis

Relative abundance of Streptococcus Sanguinis in supragingival plaque samples will be measured using PCR technique.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: