Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the present study is to evaluate the efficacy of 5 mouthwashes, based on different ingredients, in the treatment of generalised gingivitis.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential oils | Experimental | Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol |
|
| Essential oils in combination with clorhexidine 0,12% | Experimental | Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine |
|
| Placebo mouthwash | Placebo Comparator | Water, colorant, sweetener |
|
| Clorhexidine 0,20% in combination with aroma oils | Experimental | Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender |
|
| Prebiotic | Experimental | Mouthwash based on prebiotic |
|
| Hydrogen peroxide | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essential oils | Drug | Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Blagovesta Yaneva, PhD | Plovdiv Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blagovesta Yaneva | Plovdiv | 4000 | Bulgaria |
Not provided
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.
Not provided
Not provided
Participants and providers did not have information about the ingredients in the mouthwashes.
Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil |
|
| Essential oils in combination with chlorhexidine 0,12% | Drug | Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days. |
|
| Placebo mouthwash | Drug | Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days. |
|
| Chlorhexidine 0,20 % in combination with aroma oils | Drug | Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days. |
|
| Prebiotic | Drug | Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days. |
|
| Hydrogen peroxide 0,8 % | Drug | Participants were asked to rinse with 15 ml mouthwash twice daily for 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. |
| 21 days |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009822 | Oils, Volatile |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
Not provided
Not provided