Clinical Trial for Evaluating the Effectiveness and Safety of a New Dental Plaque Removal Device: Microscale Mist Unit

被引:1
作者
Hihara, Hiroki [1 ]
Izumita, Kuniyuki [2 ]
Iwatsu, Misato [1 ]
Sato, Tomoya [1 ]
Tagaino, Ryo [1 ,2 ]
Shobara, Kenta [1 ]
Shinohara, Yuta [1 ]
Hatakeyama, Takanori [1 ]
Kayaba, Chie [3 ]
Sato, Mariko [3 ]
Tokue, Ayako [3 ]
Sugawara, Tomoko
Ashino, Kanamai [3 ]
Ikeda, Koji
Aida, Jun [4 ]
Sasaki, Keiichi [1 ]
机构
[1] Tohoku Univ, Div Adv Prosthet Dent, Aoba Ku, Grad Sch Dent, 4-1 Seiryo machi, Sendai, Miyagi 9808575, Japan
[2] Tohoku Univ, Perioperat Oral Hlth Management, Grad Sch Dent, 4-1 Seiryo machi,Aoba Ku, Sendai, Miyagi 9808575, Japan
[3] Tohoku Univ Hosp, Dept Dev Promot, Clin Res Innovat & Educ Ctr, I-1 Seiryo machi, Sendai, Miyagi 9808574, Japan
[4] Tokyo Med & Dent Univ, Grad Sch Med & Dent Sci, Dept Oral Hlth Promot, I-5-45 Yushima,Bunkyo Ku, Tokyo 1138510, Japan
来源
ANTIBIOTICS-BASEL | 2022年 / 11卷 / 06期
基金
日本学术振兴会;
关键词
dental biofilm; clinical trial; oral care; oral mucosa; medical device; ORAL CARE; PNEUMONIA; TONGUE; EFFICACY; BIOFILM; JET;
D O I
10.3390/antibiotics11060825
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
This study evaluates the effectiveness and safety of a microscale mist unit (MSM-UNIT) that sprays high-speed fine water droplets to remove dental plaque adhering to the oral mucosa (tongue and palate) and tooth surface. Fifteen patients who had difficulty self-managing sufficient oral care were included in this study. Effectiveness was evaluated for at least five patients' tongues, palate mucosas, and tooth surfaces, and safety evaluation was conducted at all three sites for all patients. Effectiveness was evaluated using the rate of degree of dental plaque removal. Safety was evaluated using a numerical rating scale (NRS) for pain and symptoms of inflammation. An operator who performed treatment and an evaluator who evaluated effectiveness and safety were designated. In addition, an image judgment committee judged effectiveness. Although evaluation of the tongue varied between the evaluators and the image judgment committee, the rates of degree for all plaque removal increased in all regions. In addition, low pain NRS results and minimal symptoms of inflammation were observed and within an acceptable range. The MSM-UNIT can be used effectively and safely for removing oral plaque not only from teeth, but also from the oral mucosa.
引用
收藏
页数:14
相关论文
共 15 条
[11]   An Open-Label, Randomized, Prospective, Comparative, Three-Arm Clinical Trial to Evaluate the Safety and Effectiveness of Apremilast with Three Different Titration Methods in Patients with Chronic Plaque Psoriasis in India [J].
Viswanath, Vishalakshi ;
Joshi, Pradnya ;
Lawate, Prakash ;
Tare, Dakshata ;
Dhoot, Dhiraj ;
Mahadkar, Namrata ;
Barkate, Hanmant .
PSORIASIS-TARGETS AND THERAPY, 2022, 12 :53-61
[12]   Interim safety analysis of the first-in-human clinical trial of the Versius surgical system, a new robot-assisted device for use in minimal access surgery [J].
Dhananjay Kelkar ;
Mahindra A. Borse ;
Girish P. Godbole ;
Utkrant Kurlekar ;
Mark Slack .
Surgical Endoscopy, 2021, 35 :5193-5202
[13]   Interim safety analysis of the first-in-human clinical trial of the Versius surgical system, a new robot-assisted device for use in minimal access surgery [J].
Kelkar, Dhananjay ;
Borse, Mahindra A. ;
Godbole, Girish P. ;
Kurlekar, Utkrant ;
Slack, Mark .
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, 2021, 35 (09) :5193-5202
[14]   Evaluating the effectiveness and safety of pulsed dye laser alone, the combination of pulsed dye laser and botulinum toxin type A, and the combination of pulsed dye laser and triamcinolone injection in the treatment of hypertrophic and keloid scars: a three-arm randomized controlled clinical trial [J].
Atefi, Najmolsadat ;
Jafari, Mohammad Amin ;
Roohaninasab, Masoumeh ;
Dehghani, Abbas ;
Jafarzadeh, Alireza ;
Peighambari, Seyed Babak ;
Peighambari, Arash ;
Goodarzi, Azadeh .
LASERS IN MEDICAL SCIENCE, 2025, 40 (01)
[15]   Performance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study) [J].
Murina, Filippo ;
Inghirami, Paolo ;
Biri, Marius ;
Sirbu, Daniela ;
Barattini, Dionisio Franco ;
Sbrocca, Federica ;
Ardolino, Luca Ivan ;
Mangrella, Mario ;
Casolati, Elena ;
Ro, Serban ;
An, Ciprian Doru Cri .
JMIR RESEARCH PROTOCOLS, 2023, 12