Effect of Novel Oral Hygiene Regimen on Non-surgical Treatment of Stage II and III Periodontitis

NCT05137392 | Completed

• 1 other identifier: iBrush0817
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. The improvement of the patient's adherence to good oral hygiene is of great importance to obtain the satisfactory treatment outcomes. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New electric artificial intelligence powered toothbrushes are able to precisely sense the location of the brushing being performed by the patient and transmit information to the clinician who is able to analyze the data and provide targeted instructions, if needed. This study evaluates whether a novel oral hygiene instruction regimen can provide some additional benefit for periodontal treatment compared with routine oral hygiene instructions.

Conditions

Periodontitis

Keywords

mobile health; oral hygiene instruction; internet of things network; artificial intelligence

Outcome Measures

Primary Outcomes (2)

• changes in probing pocket depth (PPD)

  changes in probing pocket depth (PPD) after non-surgical periodontal treatment (NSPT)

  from baseline to 6 months

• changes in proportion of periodontal pocket closure

  changes in proportion of periodontal pocket closure defined by probing pocket depth (PPD) ≤4mm without bleeding on probing (BOP) after non-surgical periodontal treatment (NSPT)

  from baseline to 6 months

Secondary Outcomes (6)

• changes in clinical attachment level (CAL)

  from baseline to 6 months

• changes in bleeding on probing (BOP)

  from baseline to 6 months

• changes in periodontal soft tissue volumes

  from baseline to 6 months

• changes in oral biomarker concentration

  from baseline to 6 months

• changes in proportion of periodontal pocket closure

  from baseline to 3 months

Study Arms (2)

Test group

EXPERIMENTAL

The test group will receive the novel regimen of oral hygiene instruction, including use of a commercially available intelligent toothbrush connected to the Chinese consumer version of an application and receiving targeted oral health message as well as use of interdental toothbrush

Other: oral hygiene instruction

Control group

OTHER

The test group will receive the standard regimen of oral hygiene instruction, including use of a commercially available manual toothbrush and receiving a brochure for oral hygiene instruction as well as use of interdental toothbrush

Other: oral hygiene instruction

Interventions

oral hygiene instruction OTHER

The treatment process is identical for both test and control groups except for the methods of oral hygiene instructions. In the control group, the participants will receive the following oral hygiene instructions at completion of debridement, at week-1 and week-3. In the test group, apart from the standard oral hygiene instructions at completion of debridement, at week-1 and week-3 , additional analysis of brushing data and provision of targeted brief interventions will be provided on a daily basis for the first week, 3 times/week until week 6 and once a week thereafter until 6 months after the debridement.

Control group; Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and above
• Generalized Stage II and Stage III periodontitis
• Subjects willing to receive NSPT necessary for the management of periodontitis and to comply with research appointments/schedule
• Use of a compatible Android cell phone with Oral-B 8.5.1 Application

You may not qualify if:

• Edentulism
• Presence of any systemic disease that can alter the manifestation/outcome of periodontal treatment
• Pregnancy or intention to become pregnant at any point during the study duration
• Having received antibiotics within the previous 3 months
• Need for antibiotic prophylaxis in the context of dental treatment
• Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
• Presence of xerostomia interfering with saliva sampling
• Participation in another intervention trial
• Inability or unwillingness of individual to give written informed consent.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai PerioImplant Innovation Center, Ninth People Hospital

Shanghai, Shanghai Municipality, 200125, China

Location

Related Publications (7)

• Toniazzo MP, Nodari D, Muniz FWMG, Weidlich P. Effect of mHealth in improving oral hygiene: A systematic review with meta-analysis. J Clin Periodontol. 2019 Mar;46(3):297-309. doi: 10.1111/jcpe.13083.

  PMID: 30761580 RESULT

• Johansson LA, Oster B, Hamp SE. Evaluation of cause-related periodontal therapy and compliance with maintenance care recommendations. J Clin Periodontol. 1984 Nov;11(10):689-99. doi: 10.1111/j.1600-051x.1984.tb01317.x.

  PMID: 6594355 RESULT

• Suvan J, Leira Y, Moreno Sancho FM, Graziani F, Derks J, Tomasi C. Subgingival instrumentation for treatment of periodontitis. A systematic review. J Clin Periodontol. 2020 Jul;47 Suppl 22:155-175. doi: 10.1111/jcpe.13245.

  PMID: 31889320 RESULT

• Tonetti MS, Deng K, Christiansen A, Bogetti K, Nicora C, Thurnay S, Cortellini P. Self-reported bleeding on brushing as a predictor of bleeding on probing: Early observations from the deployment of an internet of things network of intelligent power-driven toothbrushes in a supportive periodontal care population. J Clin Periodontol. 2020 Oct;47(10):1219-1226. doi: 10.1111/jcpe.13351. Epub 2020 Aug 31.

  PMID: 32748486 RESULT

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 RESULT

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 RESULT

• Li Y, Wu X, Liu M, Deng K, Tullini A, Zhang X, Shi J, Lai H, Tonetti MS. Enhanced control of periodontitis by an artificial intelligence-enabled multimodal-sensing toothbrush and targeted mHealth micromessages: A randomized trial. J Clin Periodontol. 2024 Dec;51(12):1632-1643. doi: 10.1111/jcpe.13987. Epub 2024 Apr 17.

  PMID: 38631679 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Maurizio Tonetti, DMD PhD

  Shanghai Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 30, 2021
• Study Start: February 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: October 15, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)