Gingival Inflammation and Bleeding, Periodontal Disease
Conditions
Keywords
Periodontitis, Oral hygiene, Non-surgical periodontal treatment, Mouthwashes, Toothpastes
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.
Interventions
COMBINATION_PRODUCTActive Oral Hygiene Regimen
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.
COMBINATION_PRODUCTPlacebo Oral Hygiene Regimen
Participants use a fluoride placebo mouthwash, standard fluoride toothpaste, soft bristle toothbrush, and dental floss for the duration of the study.
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 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. |
Countries
Brazil
Contacts
CONTACTCristina C Villar, PhD
Outcome results
None listed