Chronic gingivitis Gingivitis
Conditions
Interventions
This is a randomized, triple-blind, placebo-controlled clinical trial lasting a total of four weeks. Sixty volunteers, aged between 18 and 40 years, diagnosed with generalized gingivitis induced by de
Sponsors
Universidade Evangelica de Goiás
Universidade Evangelica de Goiás
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Adult individuals (=18 years) of both sexes will be included; systemically healthy (absence of diagnosed systemic diseases that may interfere with the inflammatory response or periodontal healing); with the presence of biofilm-induced gingivitis, characterized by: bleeding on probing (BOP) in >30% of the evaluated sites, probing depth =3 mm in all sites, absence of clinical attachment loss and absence of radiographic bone loss; presence of at least 20 fully erupted permanent teeth (excluding third molars); capacity and willingness to understand and sign the Informed Consent Form and adhere to the study protocol.
Exclusion criteria
Exclusion criteria: The following will be excluded: pregnant or breastfeeding women; individuals with systemic diseases that may interfere with periodontal condition or response to treatment (e.g., uncontrolled diabetes mellitus, immunosuppressive diseases); use of antibiotics, anti-inflammatory drugs, or immunosuppressants in the last 3 months; previous history or current presence of periodontitis (according to clinical and radiographic criteria); presence of gingival diseases not induced by biofilm (e.g., drug-induced gingivitis, mucocutaneous diseases); smokers or former smokers who quit less than 12 months ago; presence of extensive prostheses or conditions that hinder periodontal evaluation; periodontal therapy performed in the last 6 months; need for antibiotic prophylaxis for routine dental procedures; known allergy to any components of the formulations used in the study; individuals who are legally incapacitated or have limitations that prevent compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the reduction of gingival inflammation over time. This outcome will be verified using the gingival index (GI), obtained by probing the gingival margin at six sites per tooth, at baseline, 2 weeks, and 4 weeks of intervention. The percentage of sites with bleeding on probing will be observed, allowing comparison between the evaluated periods and between the experimental and control groups, with a decrease in this percentage over time indicating a reduction in gingival inflammation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate biofilm control over time. This outcome will be verified through the plaque index (PI), measured at baseline, 2 weeks, and 4 weeks. The percentage of tooth surfaces with biofilm presence will be observed, allowing comparison between the evaluated periods and between the experimental and control groups, with a reduction in this percentage over time indicating better biofilm control. Evaluate the reduction in the quantification of periodontal pathogens in the subgingival biofilm over time. This outcome will be verified through microbiological sequencing of the subgingival biofilm, performed at baseline and after 4 weeks of intervention. The absolute number and/or relative abundance (%) of periodontopathogenic bacterial species will be observed, allowing comparison between the evaluated periods and between the experimental and control groups. Evaluate the reduction in the concentration of pro-inflammatory mediators in the gingival crevicular fluid over time. This outcome will be verified through multiplex analysis, performed at baseline and after 4 weeks of intervention. The concentrations (pg/mL) of pro-inflammatory cytokines, such as IL-1ß, TNF-a, and IL-6, will be observed, allowing for comparison between the evaluated periods and between the experimental and control groups. | — |
Countries
BR
Contacts
Public ContactLuciana Andraus
Universidade Evangelica de Goiás
Outcome results
None listed