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

Primary Purpose

Gingivitis, Gingival Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fatty Acids Compounds (F.A.G.) Mouthwash
Stannous Fluoride (SF) Mouthwash
Sponsored by
University of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Spontaneous gingivitis
  • Healthy individuals

Exclusion Criteria:

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

Sites / Locations

  • University of L'Aquila

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fatty Acids Compounds (FAG)

Stannous Fluoride (SF)

Arm Description

Individuals taking FAG mouthwash

Individuals taking SF mouthwash

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bleeding on Probing
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

Full Information

First Posted
July 12, 2021
Last Updated
September 21, 2023
Sponsor
University of L'Aquila
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1. Study Identification

Unique Protocol Identification Number
NCT04977778
Brief Title
Effectiveness in Dental Plaque Reduction of Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride
Official Title
Effectiveness in Dental Plaque Reduction of Two Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride: a Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 7, 2023 (Actual)
Study Completion Date
July 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of L'Aquila

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Gingival Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fatty Acids Compounds (FAG)
Arm Type
Active Comparator
Arm Description
Individuals taking FAG mouthwash
Arm Title
Stannous Fluoride (SF)
Arm Type
Active Comparator
Arm Description
Individuals taking SF mouthwash
Intervention Type
Drug
Intervention Name(s)
Fatty Acids Compounds (F.A.G.) Mouthwash
Intervention Description
Fatty Acids Compounds (F.A.G.) Mouthwash
Intervention Type
Drug
Intervention Name(s)
Stannous Fluoride (SF) Mouthwash
Intervention Description
Stannous Fluoride (SF) Mouthwash
Primary Outcome Measure Information:
Title
Change in plaque score
Description
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
Time Frame
Baseline; 2 weeks
Secondary Outcome Measure Information:
Title
Bleeding on Probing
Description
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
Time Frame
Baseline; 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals Exclusion Criteria: Smoking Drugs prior month Dental hygiene <6 months Pregnancy
Facility Information:
Facility Name
University of L'Aquila
City
L'Aquila
State/Province
IT
ZIP/Postal Code
67100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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