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

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Essential oils
Essential oils in combination with chlorhexidine 0,12%
Placebo mouthwash
Chlorhexidine 0,20 % in combination with aroma oils
Prebiotic
Hydrogen peroxide 0,8 %
Sponsored by
Plovdiv Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gingivitis focused on measuring Gingivitis, Mouthwashes, Essential oils, chlorhexidine gluconate, hydrogen peroxide, prebiotics, chlorhexidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Blagovesta Yaneva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Essential oils

Essential oils in combination with clorhexidine 0,12%

Placebo mouthwash

Clorhexidine 0,20% in combination with aroma oils

Prebiotic

Hydrogen peroxide

Arm Description

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

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

Water, colorant, sweetener

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

Mouthwash based on prebiotic

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 22, 2021
Last Updated
January 28, 2021
Sponsor
Plovdiv Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04733196
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Plovdiv Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Gingivitis, Mouthwashes, Essential oils, chlorhexidine gluconate, hydrogen peroxide, prebiotics, chlorhexidine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
Participants and providers did not have information about the ingredients in the mouthwashes.
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Essential oils
Arm Type
Experimental
Arm Description
Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol
Arm Title
Essential oils in combination with clorhexidine 0,12%
Arm Type
Experimental
Arm Description
Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine
Arm Title
Placebo mouthwash
Arm Type
Placebo Comparator
Arm Description
Water, colorant, sweetener
Arm Title
Clorhexidine 0,20% in combination with aroma oils
Arm Type
Experimental
Arm Description
Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender
Arm Title
Prebiotic
Arm Type
Experimental
Arm Description
Mouthwash based on prebiotic
Arm Title
Hydrogen peroxide
Arm Type
Experimental
Arm Description
Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil
Intervention Type
Drug
Intervention Name(s)
Essential oils
Intervention Description
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
Essential oils in combination with chlorhexidine 0,12%
Intervention Description
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
Placebo mouthwash
Intervention Description
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine 0,20 % in combination with aroma oils
Intervention Description
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
Prebiotic
Intervention Description
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
Hydrogen peroxide 0,8 %
Intervention Description
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Primary Outcome Measure Information:
Title
Change from baseline bleeding index at 21 day.
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Change from baseline gingival index at 21 day.
Description
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.
Time Frame
21 days
Title
Change from baseline oral hygiene index at 21 day.
Description
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.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blagovesta Yaneva, PhD
Organizational Affiliation
Plovdiv Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blagovesta Yaneva
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria

12. IPD Sharing Statement

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

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