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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Essential oils
* Drug: Essential oils in combination with chlorhexidine 0,12%
* Drug: Placebo mouthwash
* Drug: Chlorhexidine 0,20 % in combination with aroma oils
* Drug: Prebiotic
* Drug: Hydrogen peroxide 0,8 %


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Essential oils<br>Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol | Drug: Essential oils<br>* Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.<br>|
| Experimental: Essential oils in combination with clorhexidine 0,12%<br>Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine | Drug: Essential oils in combination with chlorhexidine 0,12%<br>* Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.<br>|
| Placebo Comparator: Placebo mouthwash<br>Water, colorant, sweetener | Drug: Placebo mouthwash<br>* Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.<br>|
| Experimental: Clorhexidine 0,20% in combination with aroma oils<br>Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender | Drug: Chlorhexidine 0,20 % in combination with aroma oils<br>* Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.<br>|
| Experimental: Prebiotic<br>Mouthwash based on prebiotic | Drug: Prebiotic<br>* Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.<br>|
| Experimental: Hydrogen peroxide<br>Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil | Drug: Hydrogen peroxide 0,8 %<br>* Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis, Mouthwashes, Essential oils, chlorhexidine gluconate, hydrogen peroxide, prebiotics, chlorhexidine