Gingivitis
Conditions
Keywords
Gingivitis, Mouthwashes, Essential oils, chlorhexidine gluconate, hydrogen peroxide, prebiotics, chlorhexidine
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.
Interventions
DRUGEssential oils
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
DRUGEssential oils in combination with chlorhexidine 0,12%
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
DRUGPlacebo mouthwash
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
DRUGChlorhexidine 0,20 % in combination with aroma oils
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
DRUGPrebiotic
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
DRUGHydrogen peroxide 0,8 %
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Sponsors
Plovdiv Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants and providers did not have information about the ingredients in the mouthwashes.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline bleeding index at 21 day. | 21 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline gingival index at 21 day. | 21 days | 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. |
| Change from baseline oral hygiene index at 21 day. | 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. |
Countries
Bulgaria
Outcome results
None listed