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Completed

NCT Number: NCT05137392

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai PerioImplant Innovation Center, Ninth People Hospital

Shanghai, Shanghai Municipality, 200125, China

About this study

Dental plaque is causally linked to gingival inflammation and essential for the onset of periodontitis. The main goal of periodontal treatment is the establishment of adequate infection control to reduce the bacterial load below individual threshold levels of inflammation. Achievement of adequate oral hygiene standards is critical to effective periodontal therapy. Classical studies have shown that professional tooth cleaning during healing of subgingival debridement provides superior outcomes. Regrettably, costs do not allow routine implementation of these regimens. By far, patient-centred homecare is the most cost-effective approach to maintaining good oral hygiene. Therefore, improving the adherence with self-performed oral hygiene is a priority in periodontal practice.

Conventionally, clinicians provide oral hygiene instructions to the patients based on the results of their clinical examinations, sometimes supplemented with written information in brochure and disclosing agents to show the location of the biofilm. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New technology based on an internet of things network of intelligent toothbrushes (i-Brush) has shown excellent adherence of use in a pilot study in a maintenance population. Other studies have shown that electronic messaging and mobile health (mHealth) supported by smartphones and applications improve oral hygiene performance, particularly in younger individuals undergoing orthodontic treatment. 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. Remote sensing of oral hygiene practices through the connected intelligent powered toothbrush allows more specific and targeted messages, thereby promoting personalized oral health care and eventually improving the healing outcomes of periodontal therapy through a two-way communication between patients and clinicians. This study aims to investigate the clinical efficacy of a novel regimen consisting of a new generation of power-driven internet connected i-Brush and targeted m-Health messages in improving periodontal treatment outcomes in comparison with routine oral hygiene instructions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. changes in probing pocket depth (PPD)

    Time frame: from baseline to 6 months

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

  2. changes in proportion of periodontal pocket closure

    Time frame: from baseline to 6 months

    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)

Secondary outcomes

  1. changes in clinical attachment level (CAL)

    Time frame: from baseline to 6 months

    changes of clinical attachment level (CAL) after non-surgical periodontal treatment (NSPT)

  2. changes in bleeding on probing (BOP)

    Time frame: from baseline to 6 months

    changes in bleeding on probing (BOP) after non-surgical periodontal treatment (NSPT)

  3. changes in periodontal soft tissue volumes

    Time frame: from baseline to 6 months

    changes in periodontal soft tissue volumes or reduction of tissue edema after non-surgical periodontal treatment (NSPT)

  4. changes in oral biomarker concentration

    Time frame: from baseline to 6 months

    the changes in biomarker concentration in saliva and oral rinse after non-surgical periodontal treatment (NSPT)

  5. changes in proportion of periodontal pocket closure

    Time frame: from baseline to 3 months

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

  6. changes in probing pocket depth (PPD)

    Time frame: from baseline to 3 months

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

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study title

Impact of Intensive Oral Hygiene Regimen Based on Individualized Messages and an Intelligent Power-driven Toothbrush on Non-surgical Treatment of Stage II and III Periodontitis: A Randomized, Standard of Care-controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2021
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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