NCT04733196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 22, 2021

Last Update Submit

January 28, 2021

Conditions

Gingivitis

Keywords

GingivitisMouthwashesEssential oilschlorhexidine gluconatehydrogen peroxideprebioticschlorhexidine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline gingival index at 21 day.

    21 days

  • Change from baseline oral hygiene index at 21 day.

    21 days

Study Arms (6)

Essential oils

EXPERIMENTAL

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

Drug: Essential oils

Essential oils in combination with clorhexidine 0,12%

EXPERIMENTAL

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

Drug: Essential oils in combination with chlorhexidine 0,12%

Placebo mouthwash

PLACEBO COMPARATOR

Water, colorant, sweetener

Drug: Placebo mouthwash

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

Drug: Chlorhexidine 0,20 % in combination with aroma oils

Prebiotic

EXPERIMENTAL

Mouthwash based on prebiotic

Drug: Prebiotic

Hydrogen peroxide

EXPERIMENTAL

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

Drug: Hydrogen peroxide 0,8 %

Interventions

Essential oilsDRUG

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

Essential oils
Essential oils in combination with chlorhexidine 0,12%DRUG

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

Essential oils in combination with clorhexidine 0,12%
Placebo mouthwashDRUG

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

Placebo mouthwash
Chlorhexidine 0,20 % in combination with aroma oilsDRUG

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

Clorhexidine 0,20% in combination with aroma oils
PrebioticDRUG

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

Prebiotic
Hydrogen peroxide 0,8 %DRUG

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

Hydrogen peroxide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • severely destroyed teeth;
  • crowns;
  • non correct obturation class II and V;
  • orthodontic treatment;
  • third molars.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blagovesta Yaneva

Plovdiv, 4000, Bulgaria

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Oils, VolatilePrebiotics

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsDietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Blagovesta Yaneva, PhD

    Plovdiv Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants and providers did not have information about the ingredients in the mouthwashes.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 1, 2021

Study Start

October 1, 2020

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

BU(1)