NCT04733196

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Plovdiv Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingivitis

Interventions

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

Timeline

• Start date: 2020-10-01
• Primary completion: 2020-12-20
• Completion: 2020-12-20
• First posted: 2021-02-01
• Last updated: 2021-02-01

Locations

1 site across 1 country: Bulgaria