Clinical Effectiveness of 5 Different Mouthwashes in the Treatment of Generalised Gingivitis

Plovdiv Medical University

Status: Completed

Conditions: Gingivitis

Treatments: Drug: Chlorhexidine 0,20 % in combination with aroma oils; Drug: Essential oils in combination with chlorhexidine 0,12%; Drug: Placebo mouthwash; Drug: Essential oils; Drug: Prebiotic; Drug: Hydrogen peroxide 0,8 %

Study type: Interventional

Funder types: Other

Identifiers

NCT04733196

PlovdivMU-mouthwash

Details and patient eligibility

About

The aim of the present study is to evaluate the efficacy of 5 mouthwashes, based on different ingredients, in the treatment of generalised gingivitis.

Full description

The present clinical study aims to investigate the clinical efficacy of 5 mouthwashes based on different active substances. The study include 180 patients divided into 6 groups of 30 patients, each group rinse with one of the following mouthwashes - mouthwash based on essential oils (menthol, thymol and eucalyptus), mouthwash based on essential oils (menthol, thymol and eucalyptus) and 0.12% chlorhexidine, mouthwash based on 0,8 % hydrogen peroxide, mouthwash based on prebiotic, water based on 0.2% chlorhexidine, placebo mouthwash. Inclusion criteria are: generalized gingival inflammation, plaque index of Turesky, 1970 > 1.95, gingival index of Loe & Silness, 1963 > 0.95, no systemic diseases, no systemic medication, lack of severely damaged teeth, no large fillings, no orthodontic treatment. Patients are motivated and instructed to maintain proper and optimal personal oral hygiene. All participants undergo professional mechanical plaque removal. After instrumentation participants are instructed to rinse with 15 ml mouthwash 2 times a day for 21 days. Researchers control the amount of mouthwash used by giving a new bottle of mouthwash with the required amount for 1 patient for 1 week at the beginning of each week and taking back the bottle from the previous week. During the study period, patients are monitored on days 14 and 21, examining plaque index of Turesky, 1970, gingival index of Loe & Silness, 1963, bleeding index of Ainamo & Bay, 1975, side effects like staining, burning itching, oral lesions. At the end of the study (day 21), patients complete a questionnaire.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Plaque Index (Turesky, 1970) > 1,95;
• Gingival Index (Loe & Silness, 1963) > 0,95;
• Bleeding Index (Animo & Bay, 1975) > 30 %;
• no systemic diseases;
• no systemic medication.

Exclusion criteria

• severely destroyed teeth;
• crowns;
• non correct obturation class II and V;
• orthodontic treatment;
• third molars.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 6 patient groups, including a placebo group

Essential oils

Experimental group

Description:

Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol

Treatment:

Drug: Essential oils

Essential oils in combination with clorhexidine 0,12%

Experimental group

Description:

Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine

Treatment:

Drug: Essential oils in combination with chlorhexidine 0,12%

Placebo mouthwash

Placebo Comparator group

Description:

Water, colorant, sweetener

Treatment:

Drug: Placebo mouthwash

Clorhexidine 0,20% in combination with aroma oils

Experimental group

Description:

Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender

Treatment:

Drug: Chlorhexidine 0,20 % in combination with aroma oils

Prebiotic

Experimental group

Description:

Mouthwash based on prebiotic

Treatment:

Drug: Prebiotic

Hydrogen peroxide

Experimental group

Description:

Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil

Treatment:

Drug: Hydrogen peroxide 0,8 %