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NCT Number: NCT07803484

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

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.

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Key information

Conditions

Periodontal Disease Gingival Diseases Gingival Inflammation and Bleeding Gingivitis Hemorrhage Infections Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Pocket depth (PD) reduction

    Time frame: 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

  1. Change in Gingival Index (GI)

    Time frame: 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.

  2. Change in Plaque Index (PI)

    Time frame: 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.

  3. Clinical Attachment Level (CAL) gain

    Time frame: 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.

  4. Change in Bleeding on Probing (BOP)

    Time frame: 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.

  5. Number of residual pockets

    Time frame: 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).

  6. Change in subgingival microbiological composition

    Time frame: 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.

  7. Change in levels of immunological mediators in gingival crevicular fluid (GCF)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina C Villar, PhD

CONTACT

[email protected]

+55 11 26488055

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Acronym: PEREG

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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