NCT04977778

Brief Summary

Comparative study on the efficacy of two mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride in the reduction of plaque score in individuals with spontaneous gengivitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

July 12, 2021

Last Update Submit

September 21, 2023

Conditions

GingivitisGingival Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in plaque score

    Visual quantification of dental plaque amount on teeth buccal surfaces (wisdom teeth excluded). 0% = no visible plaque on teeth surfaces 100% = plaque visible on all teeth surfaces

    Baseline; 2 weeks

Secondary Outcomes (1)

  • Bleeding on Probing

    Baseline; 2 weeks

Study Arms (2)

Fatty Acids Compounds (FAG)

ACTIVE COMPARATOR

Individuals taking FAG mouthwash

Drug: Fatty Acids Compounds (F.A.G.) Mouthwash

Stannous Fluoride (SF)

ACTIVE COMPARATOR

Individuals taking SF mouthwash

Drug: Stannous Fluoride (SF) Mouthwash

Interventions

Fatty Acids Compounds (F.A.G.) MouthwashDRUG

Fatty Acids Compounds (F.A.G.) Mouthwash

Fatty Acids Compounds (FAG)
Stannous Fluoride (SF) MouthwashDRUG

Stannous Fluoride (SF) Mouthwash

Stannous Fluoride (SF)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals

You may not qualify if:

  • Smoking
  • Drugs prior month
  • Dental hygiene \<6 months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of L'Aquila

L’Aquila, IT, 67100, Italy

Location

MeSH Terms

Conditions

GingivitisGingival Diseases

Interventions

MouthwashesTin Fluorides

Condition Hierarchy (Ancestors)

InfectionsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and AgricultureFluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsTin CompoundsCariostatic Agents

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 27, 2021

Study Start

September 1, 2021

Primary Completion

July 7, 2023

Study Completion

July 7, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

IT(1)