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

Not Applicable

Completed

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

• Registration Number: NCT04733196
• Lead Sponsor: Plovdiv Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-20
• Status Verified: 2021-01
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-02-01
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrogen peroxide	Hydrogen peroxide 0,8 %	Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil
Essential oils	Essential oils	Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol
Essential oils in combination with clorhexidine 0,12%	Essential oils in combination with chlorhexidine 0,12%	Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine
Clorhexidine 0,20% in combination with aroma oils	Chlorhexidine 0,20 % in combination with aroma oils	Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender
Placebo mouthwash	Placebo mouthwash	Water, colorant, sweetener
Prebiotic	Prebiotic	Mouthwash based on prebiotic

Primary Outcome Measures

Name	Time	Method
Change from baseline bleeding index at 21 day.	21 days	Recording the bleeding index of Ainamo\&Bay, 1975. The index reports the presence or absence of bleeding on probing in 4 sites around every tooth. It is calculated in % for the whole dentition.

Secondary Outcome Measures

Name	Time	Method
Change from baseline gingival index at 21 day.	21 days	The gingival index of Loe, 1967 estimates the inflammation of the gingiva in 4 sites around every tooth, examining the colour, the texture, the consistency and the bleeding of the gingiva.
Change from baseline oral hygiene index at 21 day.	21 days	The index of Turesky, 1970 is used. After discolouration of the plaque its distribution is measured in 6 sites of every tooth. The mean value is calculated by summing the individual values for each tooth and dividing the sum by all the places examined.

Trial Locations

Locations (1)

Blagovesta Yaneva; 🇧🇬 Plovdiv, Bulgaria