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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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.
Participants use a fluoride placebo mouthwash, standard fluoride toothpaste, soft bristle toothbrush, and dental floss for the duration of the study.
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
University of São Paulo, School of Dentistry
São Paulo, São Paulo, Brazil
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in Gingival Index (GI)
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.
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in Plaque Index (PI)
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.
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Clinical Attachment Level (CAL) gain
The distance measured between the cemento-enamel junction and the bottom of the gingival sulcus or periodontal pocket, assessed at six sites per tooth.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in Bleeding on Probing (BOP)
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
Number of residual pockets
The quantity of sites exhibiting residual pockets (PD \>= 4 mm with bleeding on probing).
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Time frame: 3 months, 6 months, 9 months, and 12 months post-treatment
Change in subgingival microbiological composition
Subgingival plaque collected via sterile curette and analyzed by qPCR to determine total and relative bacterial quantification.
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in levels of immunological mediators in gingival crevicular fluid (GCF)
GCF collected via sterile paper strips and analyzed for host biomarkers using enzyme-linked immunosorbent assay (ELISA) techniques
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment