At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Evaluation of a Mouthwash Containing Malva Sylvestris Extract and Its Role in Reducing Oral Biofilm and Gingival Inflammation. A Randomized, Triple Masked Clinical Trial.
In Brief
A Phase 3 clinical trial evaluating experimental group 10% mouthwash of M. sylvestris extract for Periodontal Diseases. Completed, enrolled 54 participants across 1 site.
Detailed Summary
Background: For centuries, plants (and / or their products) were the only resource available for the prevention and treatment of many diseases. However, its indiscriminate use without phytochemical, pharmacological and toxicological knowledge is a concern for health. The Malva sylvestris (family Malvaceae and popularly known as Malva) is mentioned in the literature as an ethnopharmacological medicine with anti-inflammatory, antimicrobial, wound healing and other properties. For this reason, M. sylvestris presents empirical indications in dentistry, mainly in the treatment of periodontal diseases (gingivitis and periodontitis), which are highly prevalent worldwide. However, scientific evidence is scarce in information that supports the biological properties and clinical benefits attributed to it. Objective: The objective of this study was to evaluate the effect of a mouthwash based on Malva sylvestris in the control of gingival inflammation and dental biofilm. Methods: A randomized, three-group, triple-masked clinical trial was designed. Patients from the Center of Dental Clinics of the Austral University of Chile participated with a diagnosis of gingivitis and chronic periodontitis. They were distributed randomly in three study groups: 1. Chlorhexidine mouthwash 0.12%; 2. Mouthwash with extract of M. sylvestris and 3. Mouthwash control group. The indications and dosage were identical for all groups: rinse with 10 ml, for 1 minute, every 12 hours for 7 days. The gingival index and plaque control record were recorded at the beginning and end of the follow-up period (7 days). The results obtained between the groups were compared through normality test and group analysis (ANOVA/Mann-Whitney/Dunnet p \<0.05). Results: The pharmacological potential of M. sylvestris was determined in the reduction of the plaque control record and gingival index.
Study Details
Timeline
Interventions
To each patient was delivering a 150 ml bottle with the corresponding mouthwash. The indications for posology were: rinse with 10 ml of mouthwash for 1 minute in the mouth, every 12 hours for 7 days. To the follow-up of the intervention, was made telephone calls at least once a day to remember the rinse.