An interventional study of oral hygiene instruction in Periodontitis, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 100 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 160 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
changes in probing pocket depth (PPD)
changes in probing pocket depth (PPD) after non-surgical periodontal treatment (NSPT)
Time frame: 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)
Time frame: from baseline to 6 months
changes in clinical attachment level (CAL)
changes of clinical attachment level (CAL) after non-surgical periodontal treatment (NSPT)
Time frame: from baseline to 6 months
changes in bleeding on probing (BOP)
changes in bleeding on probing (BOP) after non-surgical periodontal treatment (NSPT)
Time frame: from baseline to 6 months
changes in periodontal soft tissue volumes
changes in periodontal soft tissue volumes or reduction of tissue edema after non-surgical periodontal treatment (NSPT)
Time frame: from baseline to 6 months
changes in oral biomarker concentration
the changes in biomarker concentration in saliva and oral rinse after non-surgical periodontal treatment (NSPT)
Time frame: from baseline to 6 months
changes in proportion of periodontal pocket closure
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)
Time frame: from baseline to 3 months
changes in probing pocket depth (PPD)
changes in probing pocket depth (PPD) after non-surgical periodontal treatment (NSPT)
Time frame: from baseline to 3 months
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University