Clinical Evaluation of a Mouthwash Containing Malva Sylvestris Extract.

• Status: Completed
• Trial end date: 2019-01-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aravena, Pedro, DDS, PhD
• Collaborator: Universidad Austral de Chile
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

• Code equal of higher than 2 (Basic Periodontal Examination-BPE).

• I or II ASA classification.

• Without periodontal treatment on past three months.

Exclusion Criteria:

• Acute infection

• Dental trauma

• Alveolar osteitis (Dry socket)

• Elderly dependent patients

• Orthodontic appliances

• Antibiotic therapy

• Analgesic therapy

• Heavy smokers

• Menstrual period

• Pregnants

• Lactating woman