Shanghai PerioImplant Innovation Center, Ninth People Hospital
Shanghai, Shanghai Municipality, 200125, China
NCT Number: NCT05137392
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200125, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: from baseline to 6 months
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 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 of clinical attachment level (CAL) after non-surgical periodontal treatment (NSPT)
Time frame: from baseline to 6 months
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 or reduction of tissue edema after non-surgical periodontal treatment (NSPT)
Time frame: from baseline to 6 months
the changes in biomarker concentration in saliva and oral rinse after non-surgical periodontal treatment (NSPT)
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)
Time frame: from baseline to 3 months
changes in probing pocket depth (PPD) after non-surgical periodontal treatment (NSPT)
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07731412
Body Weight, Mouth Diseases
Târgu Mureş, Romania
View Trial DetailsNCT06366295
Mouth Diseases, Periodontal Diseases
Warsaw, Masovian Voivodeship, Poland
View Trial DetailsNCT07721337
Mouth Diseases, Periodontal Diseases
Cairo, Egypt
View Trial DetailsNCT07488403
Gingival Diseases, Gingivitis
Antalya, KONYAALTI, Turkey (Türkiye)
View Trial Details