Clinical Trials Logo
  1. Home
  2. Gingivitis
  3. NCT04596761

ToothWave Calculus Reduction and Accumulation Prevention Study

Gingivitis Clinical Trial

Official title:
Safety and Efficacy of the ToothWave™ (Model H7001) Home Use Device for Calculus Reduction and Prevention of Calculus Accumulation

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of the home-use device ToothWave (Model H7001) for calculus reduction and the prevention of calculus accumulation.

Clinical Trial Description

This is a parallel group, single-blind, randomized, and controlled prospective study aimed to evaluate the safety and efficacy of the ToothWave in calculus reduction and prevention of calculus accumulation. Eligible subjects will undergo a dental prophylaxis, and will enter a two-month run-in phase. A Volpe-Manhold Index (V-MI) calculus examination will be per-formed at the end of the run-in phase. A minimum of 90 qualified subjects (completers) who will form at least 9 mm of calculus on the lingual surface of the mandibular anterior teeth and will qualify to continue participation ac-cording to the eligibility criteria and will be randomly assigned to either the ToothWave or the control brush (ADA-accepted powered TB) group. Subjects will be stratified according to calculus levels (which indicates the calculus growth rate). Stratification will also be conducted according to age, gender, and ethnic group. Subjects will brush twice daily, unsupervised, during a three-month test period, returning at Weeks 3, 6 and 12 for safety and V-MI examinations. An additional visit will be conducted at week 9, during which a supervised brushing will be conducted. The study test phase will include a total of 168 treatment sessions and 5 clinic visits over a period of 12 weeks. For each subject, assessment data will be collected at baseline, and at 3, 6 and 12 weeks of the test phase. The average data sets will be calculated for each group. Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the ToothWave and standard fluoride toothpaste. The control group will use a regular powered toothbrush and standard fluoride toothpaste. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04596761
Study type Interventional
Source Home Skinovations Ltd.
Contact
Status Completed
Phase N/A
Start date July 15, 2020
Completion date December 10, 2020
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05568290 - Interleukin-38 Levels in Individuals With Periodontitis
Completed NCT04402996 - Meteorin-like Levels in Individuals With Periodontitis
Not yet recruiting NCT06016023 - Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
Not yet recruiting NCT05497895 - The Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients Early Phase 1
Completed NCT02884817 - Essential Oil+ELA, Plaque and Gingivitis Phase 4
Completed NCT02633345 - Effects on Tablets Containing Probiotic Candidate Strains N/A
Completed NCT02552589 - Effect of Toothpaste on the Reduction of Plaque and Inflammation N/A
Unknown status NCT01956656 - Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis N/A
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Completed NCT02515929 - Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With OPCs Phase 4
Completed NCT02235532 - Effects of Aloe Vera Toothpaste on Periodontal Parameters N/A
Completed NCT01941797 - Experimental Peri-implant Mucositis in Humans N/A
Completed NCT02508987 - Obesity and Oxidative Stress in Patients With Different Periodontal Status N/A
Unknown status NCT01197105 - Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children Phase 1/Phase 2
Completed NCT01593540 - Clinical Examination of Metal Free Interdental Brushes Phase 4
Completed NCT01236963 - Essential Oils Mouth Rinse and Dental Floss: Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation N/A
Completed NCT02102295 - Effects of Antioxidant Dentifrice on Gingivitis Phase 3
Completed NCT06140784 - A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices N/A
Completed NCT02937636 - To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population N/A
Completed NCT06212908 - Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer N/A