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

Sponsor
University of L'Aquila (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04977778
Collaborator
(none)
30
Enrollment
2
Arms
8.9
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Fatty Acids Compounds (F.A.G.) Mouthwash
  • Drug: Stannous Fluoride (SF) Mouthwash
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness in Dental Plaque Reduction of Two Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride: a Comparative Study
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in plaque score [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

Secondary Outcome Measures

  1. Bleeding on Probing [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Spontaneous gingivitis

  • Healthy individuals

Exclusion Criteria:

  • Smoking

  • Drugs prior month

  • Dental hygiene <6 months

  • Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of L'Aquila

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Davide Pietropaoli, PI, University of L'Aquila
ClinicalTrials.gov Identifier:
NCT04977778
Other Study ID Numbers:
  • 77593/2021
First Posted:
Jul 27, 2021
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gingivitis
Dental Plaque
Gingival Diseases
Fluorides
Tin Fluorides

Study Results

No Results Posted as of Jul 27, 2021