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

NCT ID: NCT04733196

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2020-12-20

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.

Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
Participants and providers did not have information about the ingredients in the mouthwashes.

Study Groups

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Essential oils

Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol

Group Type EXPERIMENTAL

Essential oils

Intervention Type DRUG

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Essential oils in combination with clorhexidine 0,12%

Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine

Group Type EXPERIMENTAL

Essential oils in combination with chlorhexidine 0,12%

Intervention Type DRUG

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Placebo mouthwash

Water, colorant, sweetener

Group Type PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type DRUG

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Clorhexidine 0,20% in combination with aroma oils

Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender

Group Type EXPERIMENTAL

Chlorhexidine 0,20 % in combination with aroma oils

Intervention Type DRUG

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Prebiotic

Mouthwash based on prebiotic

Group Type EXPERIMENTAL

Prebiotic

Intervention Type DRUG

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Hydrogen peroxide

Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil

Group Type EXPERIMENTAL

Hydrogen peroxide 0,8 %

Intervention Type DRUG

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Interventions

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Essential oils

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Intervention Type DRUG

Essential oils in combination with chlorhexidine 0,12%

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Intervention Type DRUG

Placebo mouthwash

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Intervention Type DRUG

Chlorhexidine 0,20 % in combination with aroma oils

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Intervention Type DRUG

Prebiotic

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Intervention Type DRUG

Hydrogen peroxide 0,8 %

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Plovdiv Medical University

OTHER

Sponsor Role lead

Responsible Party

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Blagovesta Yaneva

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Blagovesta Yaneva, PhD

Role: PRINCIPAL_INVESTIGATOR

Plovdiv Medical University

Locations

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Blagovesta Yaneva

Plovdiv, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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PlovdivMU-mouthwash

Identifier Type: -

Identifier Source: org_study_id

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