Gingivitis Clinical Trial
Official title:
Safety and Efficacy of the ToothWave™ (Model H7001) Home Use Device for Calculus Reduction and Prevention of Calculus Accumulation
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.
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. ;
| 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 |
NCT02633345 -
Effects on Tablets Containing Probiotic Candidate Strains
|
N/A | |
| Completed |
NCT02552589 -
Effect of Toothpaste on the Reduction of Plaque and Inflammation
|
N/A | |
| Completed |
NCT02884817 -
Essential Oil+ELA, Plaque and Gingivitis
|
Phase 4 | |
| Completed |
NCT02515929 -
Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With OPCs
|
Phase 4 | |
| Completed |
NCT02980497 -
Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study
|
N/A | |
| Completed |
NCT02235532 -
Effects of Aloe Vera Toothpaste on Periodontal Parameters
|
N/A | |
| Unknown status |
NCT01956656 -
Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
|
N/A | |
| Completed |
NCT02508987 -
Obesity and Oxidative Stress in Patients With Different Periodontal Status
|
N/A | |
| Completed |
NCT01941797 -
Experimental Peri-implant Mucositis in Humans
|
N/A | |
| Completed |
NCT01593540 -
Clinical Examination of Metal Free Interdental Brushes
|
Phase 4 | |
| Unknown status |
NCT01197105 -
Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children
|
Phase 1/Phase 2 | |
| 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 |