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CompletedNCT04977778Updated Sep 26, 2023

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

An interventional study of Fatty Acids Compounds (F.A.G.) Mouthwash and Stannous Fluoride (SF) Mouthwash in Gingivitis and Gingival Diseases, sponsored by University of L'Aquila. Completed at 1 site in Italy. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by University of L'Aquila · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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

02

Conditions studied

  • Gingivitis
  • Gingival Diseases
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 34 is below the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

University of L'Aquila is the lead sponsor of 45 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy individuals

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Drugs prior month
  • Dental hygiene \<6 months
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Fatty Acids Compounds (FAG)

    Individuals taking FAG mouthwash

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

  • Active comparator
    Stannous Fluoride (SF)

    Individuals taking SF mouthwash

    Drug: Stannous Fluoride (SF) Mouthwash

Interventions

  • DrugFatty Acids Compounds (F.A.G.) Mouthwash

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

  • DrugStannous Fluoride (SF) Mouthwash

    Stannous Fluoride (SF) Mouthwash

06

What researchers measure

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

    Time frame: Baseline; 2 weeks

Secondary outcomes

  1. 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

    Time frame: Baseline; 2 weeks

07

Study locations

1 site
  • University of L'Aquila
    L'Aquila, IT 67100, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04977778
Lead sponsor
University of L'Aquila
Responsible party
Davide Pietropaoli (PI, University of L'Aquila) — Principal investigator
First posted
Jul 27, 2021
Start date
Sep 1, 2021
Primary completion
Jul 7, 2023
Completion
Jul 7, 2023
Last update
Sep 26, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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