Chronic gingivitis
Conditions
Interventions
Experimental group: 30 patients will receive a fluoride toothpaste containing 0.1% oleanolic acid and 0.05% eugenol in a dical base, a soft bristle manual toothbrush and a placebo control mouthwash in
Other
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Faculdade de Odontologia da Universidade de São Paulo
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Good general health; ability to read, understand and sign the Informed Consent Form; willingness to comply with study procedures and sampling schedules; at least 20 natural permanent teeth without crown (excluding third molars); mean gingival index (Löe & Silness 1967) greater than or equal to 1.5; at least 6 teeth with a minimum of one bleed site on marginal probing
Exclusion criteria
Exclusion criteria: Have a history of allergy to previously used oral hygiene products or their ingredients; have a history of alcohol or drug abuse; have infectious diseases (e.g hepatitis or AIDS); have a medical condition that could compromise patient safety or the quality of study results; need antibiotics before dental treatment; use anti-inflammatory, immunosuppressive, antimicrobial, anticoagulant or antibiotic drugs within 30 days prior to the start of the study; continuous use of medications known to affect gum tissues; have important oral conditions (including but not limited to oral or soft tissue hard tumor (s), gingival hyperplasia, moderate to severe periodontitis including two or more periodontal pockets greater than 5 mm with bleeding on probing),presence of orthodontic bands or removable partial dentures; presence of five or more carious lesions requiring immediate restorative treatment; being pregnant or breastfeeding; referring to the use of tobacco products; having any pre-existing medical condition prohibiting the subject from eating or drinking for periods of up to 2 hours, have participated in a clinical study involving oral care products in the previous month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: To evaluate the gingival severity index (GSI), obtained based on GI data with no separate or additional clinical assessment, is a proportion reflecting the percentage of gingival sites that bleed (rating from 0 to 1). According to the grading criteria, if the GI is scored 0 or 1 then the GSI will be scored 0 (no bleeding). A GI score of 2 or 3 will be scored as GSI 1 (bleeding). An ISG score greater than 0.5 will indicate a considerable level of gingivitis.;Outcome found 1. We evaluated the gingival severity index (GSI), obtained based on GI data with no separate or additional clinical assessment, is a proportion reflecting the percentage of gingival sites that bleed (rating from 0 to 1). GSI scores greater than or equal to 0.5 indicated a considerable level of gingivitis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary outcome 1. Loe & Silness Gingival Index score will be assigned to all scoreable surfaces of the maxillary and mandibular teeth. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored. Score 0 indicate absence of inflammation, score 1 mild inflammation: slight change in color and mild edema with little change in texture, no bleeding on probing. Score 2 moderate inflammation: moderate glazing, redness, edema and hypertrophy, bleeding on probing. Score 3 severe inflammation: marked redness, hypertrophy, edema and ulceration, tendency for spontaneous bleeding.;Secondary outcome found 1: The Loe & Silness gingival index was accurately evaluated. The index score was assigned to all scoreable surfaces of the maxillary and mandibular teeth. A whole mouth mean score for each subject was determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored according to the scores in the previous chart.;Expected secondary outcome 2. It will be used the Quigley-Hein Plaque Index. In order to obtain it, first will be use a red/blue solution to dye the plaque. A score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored. Score 0 indicate absence of plaque, score 1 separate flecks of plaque at the cervical margin; score 2 a thin, continuous band of plaque (up to 1 mm) at the cervical margin; score 3 a band of plaque wider than 1 mm , but covering less than 1/3 of the side of the crown of the tooth; score 4 plaque covering at least 1/3, but less than 2/3 of | — |
Countries
Brazil
Contacts
Public ContactGiuseppe Romito
Faculdade de Odontologia de Universidade de São Paulo.
Outcome results
None listed