Tokyo, Aug. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062475) titled 'Comparison of Treatment Time and Patient-Reported Outcomes Between Erythritol Powder Air-Polishing and Rubber Cup Polishing: A Randomized Crossover Clinical Trial' on Aug. 6.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - The Nippon Dental University
Condition:
Condition - Systemically healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare treatment time and patient-reported outcomes (PROs) between erythritol powder air-polishing (EPAP) and conventional rubber cup polishing (RC) for supragingival plaque removal in systemically healthy adults using a randomized crossover clinical trial. The primary outcome is treatment time.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Erythritol powder air-polishing (EPAP). One treatment session. Supragingival plaque removal of the full dentition using the AIRFLOW Prophylaxis Master (EMS, Nyon, Switzerland) with AIRFLOW PLUS erythritol powder (mean particle size approximately 14 um). The handpiece was positioned approximately 3 to 5 mm from the tooth surface at an angle of approximately 30 to 60 degrees. Treatment was continued until no disclosed supragingival plaque was visually detectable. Each participant received the alternate intervention after a washout period of at least 2 weeks.
Interventions/Control_2 - Rubber cup polishing (RC). One treatment session. Supragingival plaque removal of the full dentition was performed using a rubber prophylaxis cup attached to a low speed handpiece operating at approximately 1000 to 2000 rpm with prophylaxis paste (RDA 250). Interproximal surfaces inaccessible to the rubber cup were cleaned using a prophylaxis point. Treatment was continued until no disclosed supragingival plaque was visually detectable. Each participant received the alternate intervention after a washout period of at least 2 weeks.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - . Systemically healthy adults aged 20-50 years.
2. At least 24 natural teeth.
3. No probing pocket depth of 5 mm or greater.
4. No clinical attachment loss.
5. Able to provide written informed consent.
Key exclusion criteria - 1.Systemic diseases affecting periodontal health.
2.Systemic antibiotic therapy within the previous 3 months.
3.Current smokers.
4.Pregnancy or lactation.
5.Removable prostheses.
6.Orthodontic appliances.
7.History of periodontitis.
8.Any condition considered by the investigators to interfere with study participation.
Target Size - 21
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2021 Year 10 Month 13 Day
Date of IRB - 2021 Year 11 Month 05 Day
Anticipated trial start date - 2021 Year 11 Month 09 Day
Last follow-up date - 2022 Year 01 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071499
Disclaimer: Curated by HT Syndication.