Experimental dentifrice based on Red Propolis on orthodontic patients

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2024
INTERVENTION: D05.750.078.840.762 D25.376 Double‐blind, controlled, matched clinical trial (the same variable was measured before and after treatment in the same subjects). The sample was calculated considering a significance level of 5% and a power of 0.95% of the study. Forty volunteers, aged between 14 and 30 years, were selected and divided into two groups, according to orthodontic appliances: 20 participants who wore self‐ligating orthodontic brackets and 20 without the use of orthodontic appliances. Among the inclusion criteria, it was established that the patients had good systemic health. The exclusion criteria are: use of antibiotic therapy in the last si Xmonths, use of anti‐inflammatory drugs in the last three months, smoking, pregnancy and fixed prosthesis. The dentifrices analyzed will be: an experimental red toothpaste based on propolis and a commercial dentifrice Colgate Total 12 (Colgate‐Palmolive, São Paulo, SP, Brazil). Patients and clinicians involved in the research will not receive any information about the products, and the identity of each will be revealed after the study ends. Patients will not receive oral hygiene instructions and will be instructed not to brush their teeth 2 hours before the experiment. They will also be instructed not to eat or drink before and during the experiment. Toothpastes will be randomly delivered to each subject. Clinical analysis (biofilm inde Xand periodontal index) and collection of unstimulated saliva will be performed before and after 21 days of toothpaste use. Participants will repeat these procedures for each dentifrice after 21 days of wash‐out CONDITION: Periodontal Index PRIMARY OUTCOME: It is expected to observe a reduction in periodontal indices after the use of the experimental toothpaste SECONDARY OUTCOME: There is no secondary stage. INCLUSION CRITERIA: Patients had good systemic health; age between 14 and 30 years old; both sexes
Epistemonikos ID: 88eca07273a463b72d2a63e9e4efbcad9af80623
First added on: Apr 11, 2025