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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733196
• Other study ID #: PlovdivMU-mouthwash
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: January 2021
• Source: Plovdiv Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Essential oils
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
• Essential oils in combination with chlorhexidine 0,12%
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
• Placebo mouthwash
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
• Chlorhexidine 0,20 % in combination with aroma oils
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
• Prebiotic
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
• Hydrogen peroxide 0,8 %
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Locations

Country	Name	City	State
Bulgaria	Blagovesta Yaneva	Plovdiv

Sponsors (1)

Lead Sponsor	Collaborator
Plovdiv Medical University

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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