Effectiveness in Dental Plaque Reduction of Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride

September 21, 2023 updated by: Davide Pietropaoli, University of L'Aquila

Effectiveness in Dental Plaque Reduction of Two Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride: a Comparative Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • IT
      • L'Aquila, IT, Italy, 67100
        • University of L'Aquila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy individuals

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fatty Acids Compounds (FAG)
Individuals taking FAG mouthwash
Drug: Fatty Acids Compounds (F.A.G.) Mouthwash
Fatty Acids Compounds (F.A.G.) Mouthwash
Active Comparator: Stannous Fluoride (SF)
Individuals taking SF mouthwash
Drug: Stannous Fluoride (SF) Mouthwash
Stannous Fluoride (SF) Mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plaque score
Time Frame: Baseline; 2 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on Probing
Time Frame: Baseline; 2 weeks

Quantifying gingival bleeding after gentle gum manipulation assessed on 6 points per tooth (exluded wisdom teeth).

0% = No bleeding on all assessed points 100% = Bleeding on all assessed points
Baseline; 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

July 7, 2023

Study Completion (Actual)

July 7, 2023

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 25, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77593/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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