Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use

Status Completed

Clinical Trial Summary

The primary objective of this exploratory study is to evaluate the efficacy of an Oral Irrigator in the reduction of gingivitis compared to a negative control over a 3 week period by using the Modified Gingival Index and the Gingival Bleeding Index. The secondary objective is to evaluate the efficacy of an Oral Irrigator in the reduction of plaque compared to a negative control using the extended Turesky Modified Quigley-Hein Index (TQHPI) after 3 weeks of use.

Clinical Trial Description

This is a single-center, examiner-blind, three (3) week, two (2) treatment, parallel group, randomized study design. Thirty (30) subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Subjects will be evaluated for gingivitis using the Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI) and evaluated for plaque using the Turesky Modified Quigley-Hein Plaque Index (TQHPI) at two (2) time points: Baseline and after three (3) weeks of product use. Qualified subjects will be stratified and randomly assigned to one of the two treatment groups, toothbrushing on conjunction with an Oral Irrigator or toothbrushing without an Oral Irrigator (N=15/treatment). Subjects will be instructed to brush twice a day for approximately three (3) weeks with their assigned products and return for plaque and gingivitis measures at approximately three (3) weeks after the Baseline visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04899440
Study type	Interventional
Source	Procter and Gamble
Contact
Status	Completed
Phase
Start date	June 3, 2021
Completion date	June 24, 2021

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	`NCT02552589` - Effect of Toothpaste on the Reduction of Plaque and Inflammation	N/A
Completed	`NCT02884817` - Essential Oil+ELA, Plaque and Gingivitis	Phase 4
Completed	`NCT02633345` - Effects on Tablets Containing Probiotic Candidate Strains	N/A
Completed	`NCT02235532` - Effects of Aloe Vera Toothpaste on Periodontal Parameters	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
Unknown status	`NCT01956656` - Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis	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
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