Tokyo, Oct. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059266) titled 'Observation of the effects of non-surgical periodontal treatment on vascular function and biomarkers in blood and saliva' on Oct. 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - The Nippon Dental University
Condition:
Condition - Periodontitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate whether full-mouth debridement using Er:YAG laser reduce periodontal parameters and systemic effects compared to treatment using ultrasonic scaler.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Interventions / Subgingival debridement of the full mouth completed in one session using an Er:YAG laser.
Interventions/Control_2 - Control / Subgingival debridement of the full mouth completed in one session using an ultrasonic scaler.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (a) Generalized stage II to IV periodontitis, (b) 12 or more remaining teeth.
Key exclusion criteria - (a) Less than 12 remaining teeth (excluding third molars and remaining roots), (b) Periodontal treatment received in the past year, (c) Systemic diseases that may affect periodontitis or periodontal treatment, (d) Pregnant or breastfeeding women, (e) Systemic administration of antibiotics or anti-inflammatory analgesics within three months prior to periodontal examination.
Target Size - 28
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2023 Year 03 Month 23 Day
Date of IRB - 2023 Year 05 Month 23 Day
Anticipated trial start date - 2023 Year 11 Month 24 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066405
Disclaimer: Curated by HT Syndication.