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

NCT07803484 | Not Yet Recruiting Phase 3

• 1 other identifier: CRO-2025-04-PERIO-RG-BZ-CB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontal Disease; Gingival Inflammation and Bleeding

Keywords

Periodontitis; Oral hygiene; Non-surgical periodontal treatment; Mouthwashes; Toothpastes

Outcome Measures

Primary Outcomes (1)

• Pocket depth (PD) reduction

  The distance measured between the gingival margin and the bottom of the gingival sulcus or the periodontal pocket, assessed at six sites per tooth using a calibrated periodontal probe.

  Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment

Secondary Outcomes (7)

• Change in Gingival Index (GI)

  Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment

• Change in Plaque Index (PI)

  Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment

• Clinical Attachment Level (CAL) gain

  Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment

• Change in Bleeding on Probing (BOP)

  Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment

• Number of residual pockets

  3 months, 6 months, 9 months, and 12 months post-treatment

Study Arms (2)

Test Group

EXPERIMENTAL

Participants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen (Regimen I) consisting of a chlorhexidine mouthwash, stannous fluoride toothpaste, toothbrush, and floss for 3 weeks. Afterward, they switch to Regimen II consisting of a CPC/Zinc Lactate mouthwash, stannous fluoride toothpaste, toothbrush, and floss.

Combination Product: Active Oral Hygiene Regimen

Negative Control Group

PLACEBO COMPARATOR

Participants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen consisting of a fluoride placebo mouthwash, standard fluoride toothpaste, toothbrush, and floss for the duration of the study.

Combination Product: Placebo Oral Hygiene Regimen

Interventions

Placebo Oral Hygiene Regimen COMBINATION_PRODUCT

Participants use a fluoride placebo mouthwash, standard fluoride toothpaste, soft bristle toothbrush, and dental floss for the duration of the study.

Negative Control Group

Active Oral Hygiene Regimen COMBINATION_PRODUCT

Participants use a 0.12% chlorhexidine mouthwash and stannous fluoride toothpaste for 3 weeks (Regimen I). Afterwards, they switch to a 0.09% CPC and 0.28% Zinc Lactate mouthwash with fluoride and stannous fluoride toothpaste (Regimen II). Both regimens include a soft bristle toothbrush and dental floss.

Test Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (2)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

University of São Paulo, School of Dentistry

São Paulo, São Paulo, 90035-003, Brazil

Location

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Hemorrhage; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cristina C Villar, PhD

CONTACT

+55 11 26488055; villar@usp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All products will be covered with white over-wrapping in order to conceal product identity. The examining dentist and their staff will remain blinded to product assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)