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

Randomised Controlled Trial Comparing the Clinical Effectiveness of 5 Mouthwashes Based on Essential Oils, Chlorhexidine, Hydrogen Peroxide and Prebiotic, in Gingivitis Treatment

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Blagovesta Yaneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Essential oils; Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol	Drug: Essential oils; Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Experimental: Essential oils in combination with clorhexidine 0,12%; Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine	Drug: Essential oils in combination with chlorhexidine 0,12%; Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Placebo Comparator: Placebo mouthwash; Water, colorant, sweetener	Drug: Placebo mouthwash; Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Experimental: Clorhexidine 0,20% in combination with aroma oils; Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender	Drug: Chlorhexidine 0,20 % in combination with aroma oils; Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Experimental: Prebiotic; Mouthwash based on prebiotic	Drug: Prebiotic; Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Experimental: Hydrogen peroxide; Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil	Drug: Hydrogen peroxide 0,8 %; Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline bleeding index at 21 day.	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.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline gingival index at 21 day.	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.	21 days
Change from baseline oral hygiene index at 21 day.	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.	21 days

Collaborators and Investigators

• Sponsor: Plovdiv Medical University
• Investigators: Principal Investigator: Blagovesta Yaneva, PhD, Plovdiv Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: prebiotics; chlorhexidine; chlorhexidine gluconate; Gingivitis; Mouthwashes; Essential oils; hydrogen peroxide
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Hydrogen Peroxide; Chlorhexidine gluconate
• Other Study ID Numbers: PlovdivMU-mouthwash

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No