Gingivitis
Conditions
Interventions
In this double-blind, participants and those administering the interventions do not know which intervention individual participants are receiving, only one person in charge knows what the intervention
Sponsors
Universidade Guarulhos - UNG
Universidade Guarulhos - UNG
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Men and women; between 18 and 65 years of age; good general health (absence of any condition that may constitute a risk to the subject during participation in the study, examples: heart problems, chronic kidney problems, etc.); willingness to provide information related to their medical history; minimum of 15 permanent natural teeth without crowns (excluding third molars); average initial gingivitis index of at least 1.5, as determined by use of the gingival index; present generalized periodontitis Stages II or III, Grades A or B, based on the criteria established by the American Academy of Periodontology (2018)
Exclusion criteria
Exclusion criteria: Presence of orthodontic bands; presence of removable partial dentures; oral pathology, chronic disease or history of allergy to the active principles of dentifrices; use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication, or daily analgesics within one month of starting the study or scheduled to start such intake during the course of the study; pregnant or breastfeeding women; allergy to oral care products, personal care products or their ingredients; prolonged use of antibiotics or therapeutic mouthwash at any time during the three months prior to study entry; need for prophylaxis with antibiotics; ongoing use of medications known to affect gingival tissues (ie, calcium channel blockers, phenytoin, cyclosporine); periodontitis (purulent exudate, tooth mobility and/or extensive periodontal attachment loss); probing depth greater than 4 mm; periodontal treatment in the last 12 months before the beginning of the study; smokers (at least 10 cigarettes/day for at least 5 years) and former smokers (at least 5 years ago); history of periodontal treatment in the last six months; continuous use of oral antiseptics; use of systemic antibiotics, corticoids, non-steroidal anti-inflammatory drugs, immunosuppressants, estrogen and estrogen receptor modulators, as well as drugs that may influence bone metabolism (alendronate, calcitonin and others) in the last six months; systemic disease that may alter host response to periodontal treatment (eg diabetes) or that requires prophylactic medication for dental treatment (eg mitral valve prolapse); allergy to oral care products, personal care products or their reporting ingredients; use of orthodontic appliances, and extensive prosthetic rehabilitations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the differences in measurements performed at 6 sites per tooth (mesiobuccal, buccal, distobuccal, mesiopalatine/lingual, palatine/lingual, distopalatine/lingual), at different evaluation times (initial, 3 months and 6 months), using a North Carolina millimeter periodontal probe (PCPUNC-BR 15 HuFriedy do Brasil, Rio de Janeiro, RJ). The following parameters will be evaluated at each experimental time: presence or absence of biofilm; VPI (visible plaque index Silness & Löe - 1964 Score 0: no biofilm; Score 1: a thin layer of biofilm adhering to the free gingival margin and adjacent tooth area, which may require instruments to confirm its presence; Score 2: moderate accumulation of deposits at the tooth and gingival margin that can be seen with the naked eye; Score 3: abundance of soft matter within the gingival pocket and/or at the tooth and gingival margin). Gingival bleeding GSI (gingival index Löe & Silness - 1963 - Score 0: absence of inflammation; Score 1: mild inflammation - slight color change and slight edema, with little change in texture and no bleeding on probing; Score 2: moderate inflammation - redness, edema, and hypertrophy, and bleeding on probing; Score 3: severe inflammation - marked redness, hypertrophy, edema, and ulceration, with a tendency to spontaneous bleeding); bleeding on probing SS (presence or absence); suppuration SUP (presence or absence); probing depth - PS (distance, in millimeters, from the free gingival margin to the most apical portion of the periodontal sulcus/pocket); clinical attachment level NCI (distance, in millimeters, from the cementoenamel junction to the most apical portion of the periodontal sulcus/pocket) | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactLuciene de Figueiredo
Universidade Guarulhos - UNG
Outcome results
None listed