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

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.

• 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.
• 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.

Primary outcomes

• Pocket depth (PD) reduction [Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment]: 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.

Secondary outcomes

• Change in Gingival Index (GI) [Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment]: Evaluated using the Löe-Silness Gingival Index (score 0-3) on all scorable surfaces to determine a whole mouth mean score representing gingival inflammation and bleeding.
• Change in Plaque Index (PI) [Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment]: Evaluated using the Löe \& Silness Plaque Index (score 0-3) on all scorable surfaces to determine a whole mouth mean score representing microbial plaque accumulation.
• Clinical Attachment Level (CAL) gain [Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment]: The distance measured between the cemento-enamel junction and the bottom of the gingival sulcus or periodontal pocket, assessed at six sites per tooth.
• Change in Bleeding on Probing (BOP) [Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment]: Evaluated using the Ainamo \& Bay Index, scoring the presence or absence of bleeding in the gingival sulcus after gentle probing, expressed as a percentage of bleeding sites over total sites.
• Number of residual pockets [3 months, 6 months, 9 months, and 12 months post-treatment]: The quantity of sites exhibiting residual pockets (PD >= 4 mm with bleeding on probing).
• Change in subgingival microbiological composition [Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment]: Subgingival plaque collected via sterile curette and analyzed by qPCR to determine total and relative bacterial quantification.
• Change in levels of immunological mediators in gingival crevicular fluid (GCF) [Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment]: GCF collected via sterile paper strips and analyzed for host biomarkers using enzyme-linked immunosorbent assay (ELISA) techniques

Sex: All, ages: 30 Years to 70 Years

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.