Clinical Evaluation of a Mouthwash Containing Malva Sylvestris Extract.

NCT05138484 | Completed Phase 3 DMC

• 1 other identifier: ORD 181
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases

Keywords

Periodontal diseases; Inflammation; Malva sylvestris; Mouthwashes

Outcome Measures

Primary Outcomes (3)

• Basic periodontal examination

  The mouth is divided into sextants and using a WHO-standardized periodontal probe (Hu-FriedyⓇ), the probing of each tooth is performed in 3 points (mesial, medial and distal) by vestibular and lingual -palatal of each tooth, registering the highest value per sextant, according to the following coding: 0 (healthy tissue), 1 (positive bleeding, absence of periodontal pocket), 2 (presence of tartar, defective fillings, black area of the probe completely visible), 3 (black area of the probe partially visible, periodontal pocket of 3.5 - 5.5 mm), 4 (black area of the probe below the gingival margin, periodontal pocket greater than 5.5 mm).

  7 days

• Gingival index

  With a WHO-standardized periodontal probe (Hu-FriedyⓇ), the buccal, lingual and interdental papillae marginal gingivae are probed, using a four-point scale from 0 (absence of inflammation) to 3 (severe inflammation)

  7 days

• Plaque control record

  5 drops of Bacterial Plaque Revealing Solution (Caristop-Revelador DUAL TONE, MAVERⓇ) are applied and the patient is instructed to make movements with the tongue in such a way that it touches all dental surfaces in a time of 15 seconds . The vestibular, lingual and interproximal surfaces of all the teeth are then examined. To calculate the index, add the total number of dental surfaces with bacterial plaque, divide this number by the total number of surfaces present in the mouth and multiply by 100

  7 days

Study Arms (3)

M. sylvestris mouthwash

EXPERIMENTAL

using 10 ml, rinse for one minute, 1 time every 12 hours for 7 days.

Drug: experimental group 10% mouthwash of M. sylvestris extract

CHX mouthwash

ACTIVE COMPARATOR

using 10 ml, rinse for one minute, 1 time every 12 hours for 7 days.

Drug: experimental group 10% mouthwash of M. sylvestris extract

Placebo mouthwash

PLACEBO COMPARATOR

using 10 ml, rinse for one minute, 1 time every 12 hours for 7 days.

Drug: experimental group 10% mouthwash of M. sylvestris extract

Interventions

experimental group 10% mouthwash of M. sylvestris extract DRUG

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.

Also known as: Positive control 0.12% chlorhexidine digluconate, Negative control vehicle mouthwash

CHX mouthwash; M. sylvestris mouthwash; Placebo mouthwash

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Code equal of higher than 2 (Basic Periodontal Examination-BPE).
• I or II ASA classification.
• Without periodontal treatment on past three months.

You may not qualify if:

• Acute infection
• Dental trauma
• Alveolar osteitis (Dry socket)
• Elderly dependent patients
• Orthodontic appliances
• Antibiotic therapy
• Analgesic therapy
• Heavy smokers
• Menstrual period
• Pregnants
• Lactating woman

Sponsors & Collaborators

• Aravena, Pedro, DDS, PhD: lead
• Universidad Austral de Chile: collaborator

Study Sites (1)

Universidad Austral de Chile

Valdivia, Chile

Location

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MeSH Terms

Conditions

Periodontal Diseases; Inflammation

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruna Benso, PhD

  Faculty of Medicine, Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Each clinical record was coded by number, group and each group was assigned a color, which was stamped on the bottle of each mouthwash (bottles were of the same appearance). The masking mechanisms through coding by number, group and color, ensured that the patients did not know the specific mouthwash they received; examiners E.A and A.N were limited only to assessing the clinical aspects; and the data analysis was performed with the database using numerical coding. Only researcher B.B was aware of the real assignment by color, with its corresponding study group and number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two examiners recorded the data: sex, age, hygiene habits, systemic diseases, use of drugs and smoking. Clinical examination and registration of clinical indexes: Basic Periodontal Examination, Gingival Bleeding Index, Bacterial plaque index. Another investigator performed, through simple randomization, the patient's assignment to one of the three parallel study groups: G.1 (Positive control 0.12% chlorhexidine digluconate) G.2 (Negative control vehicle mouthwash) G.3 (experimental group 10% mouthwash of M. sylvestris extract). 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. The re-evaluation was performed 7 days after the first appointment.

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: October 20, 2017
• Primary Completion: December 17, 2018
• Study Completion: January 14, 2019
• Last Updated: December 1, 2021

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)