Clinical trial NCT04733196: Clinical Effectiveness of 5 Different Mouthwashes in the Treatment of Generalised Gingivitis
Official title: Randomised Controlled Trial Comparing the Clinical Effectiveness of 5 Mouthwashes Based on Essential Oils, Chlorhexidine, Hydrogen Peroxide and Prebiotic, in Gingivitis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: Gingivitis
Mouthwashes
Essential oils
chlorhexidine gluconate
hydrogen peroxide
prebiotics
chlorhexidine
Lead sponsor: Plovdiv Medical University
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 180 participants are assigned to 6 groups. Each group of 30 participants with gingivitis rinse with one of the mouthwashes: based on prebiotic, hydrogen peroxide, essential oils, essential oils in combination with 0,12% chlorhexidine, 0,20% chlorhexidine for 3 weeks after mechanical plaque control.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline bleeding index at 21 day.
timeFrame: 21 days
Secondary outcomes:
measure: Change from baseline gingival index at 21 day.
timeFrame: 21 days
measure: Change from baseline oral hygiene index at 21 day.
timeFrame: 21 days
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Blagovesta Yaneva
Study officials:
affiliation: Plovdiv Medical University
name: Blagovesta Yaneva, PhD
role: PRINCIPAL_INVESTIGATOR
References: