NCT04899440

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

An Experimental Clinical Study to Assess the Gingivitis and Plaque Reduction Efficacy of an Oral-Irrigator After Three Weeks of Use

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gingivitis
• Plaque

Interventions

Type	Name	Description
DEVICE	Water Flosser	A pressurized stream of water to reduce gingivitis and remove adherent plaque
OTHER	Control	No Oral Irrigator Control

Timeline

• Start date: 2021-06-03
• Primary completion: 2021-06-24
• Completion: 2021-06-24
• First posted: 2021-05-24
• Last updated: 2022-08-01
• Results posted: 2022-08-01

Locations

1 site across 1 country: United States