Efficacy of Oral Hygiene Regimens in Patients Undergoing Non-Surgical Periodontal Treatment

ClinicalTrials.gov ID

NCT07803484

Lead Sponsor

Colgate PalmoliveINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

100Estimated

Last Update Posted

Sep 3, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Mar 30, 2028Estimated

Completion Date

Apr 30, 2028Estimated

Official Title

Efficacy of Multi-component Oral Hygiene Regimens in Patients Undergoing Non-surgical Periodontal Treatment: a Multicentered Randomized Clinical Trial.

Brief Summary

The objective of this clinical study is to evaluate the efficacy of multi-component oral hygiene regimens as adjunctive to non-surgical periodontal treatment in patients with stage II periodontitis.

Detailed Description

This is a Phase III, multicenter, controlled, randomized, double-blind clinical trial with two parallel arms. A total of 100 participants, aged 30 to 70, diagnosed with stage II generalized periodontitis will undergo non-surgical periodontal treatment and be randomized to one of two at-home oral hygiene regimens. Participants will be monitored over a 12-month period to assess clinical periodontal parameters.

• Periodontal Disease
• Gingival Inflammation and Bleeding

• Active Oral Hygiene Regimen
• Placebo Oral Hygiene Regimen

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Males and females, between 30-70 years of age, inclusive.
• Good general health. Minimum of 15 uncrowned permanent natural teeth (excluding third molars and crowns).
• Clinical diagnosis of stage II generalized periodontitis.

Exclusion Criteria:

• Periodontal treatment undergone 3 months before the beginning of the study. - Mucosal oral pathology.
• Uncontrolled systemic chronic disease that may interfere with host response. - Use of anti-inflammatory and antibiotic within 3 months prior to the start of the study, scheduled to start such intake during the treatment phase, or use of therapeutic mouthwash within the last three months.
• Need for antibiotic prophylaxis.
• Participation in any other clinical study.
• Pregnant, breastfeeding, or intended to get pregnant during the study.
• Allergic to oral care products, personal care consumer products, or their ingredients.
• Ongoing use of medications known to affect the gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine).
• Current smokers and subjects with a history of alcohol or drug abuse. - Orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Colgate PalmoliveINDUSTRY

villar@usp.br+55 11 26488055

• The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis

  NCT02193165

  CompletedInterventionalPhase 3Updated Aug 17, 2015
• Effect of Novel Oral Hygiene Regimen on Non-surgical Treatment of Stage II and III Periodontitis

  NCT05137392

  CompletedInterventionalNot ApplicableUpdated Oct 25, 2023
• A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods

  NCT07211061

  CompletedInterventionalPhase 4Updated Oct 7, 2025
• Clinical Investigation of PerioGard (Test) Regimen

  NCT07210138

  CompletedInterventionalPhase 3Updated Mar 18, 2026
• Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)

  NCT02366689

  CompletedInterventionalPhase 4Updated Mar 30, 2016
• 6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health

  NCT07414173

  RecruitingInterventionalPhase 4Updated Feb 17, 2026