Evaluation of the effectiveness of toothpastes in reducing gum bleeding

Not Applicable

• Conditions: Chronic gingivitis; K05.1; C07.465.714.258.480

• Registration Number: RBR-55g6cm
• Lead Sponsor: Faculdade de Odontologia da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.