GingivitisNCT04977778
Effectiveness in Dental Plaque Reduction of Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride
A study testing Fatty Acids Compounds (F.A.G.) Mouthwash and Stannous Fluoride (SF) Mouthwash in people with Gingivitis and Gingival Diseases, run by University of L'Aquila at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Gingival Diseases
- What is being tested?
- Fatty Acids Compounds (F.A.G.) Mouthwash and Stannous Fluoride (SF) Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
Who cannot join
- Smoking
- Drugs prior month
- Dental hygiene <6 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Gingivitis, Gingival Diseases
- Being tested
- Fatty Acids Compounds (F.A.G.) Mouthwash, Stannous Fluoride (SF) Mouthwash
- Medical subject headings
- Gingivitis, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty Acids Compounds (F.A.G.) MouthwashDrug
Fatty Acids Compounds (F.A.G.) Mouthwash
Stannous Fluoride (SF) MouthwashDrug
Stannous Fluoride (SF) Mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Fatty Acids Compounds (FAG) | Active comparator | Individuals taking FAG mouthwash Receives: Drug: Fatty Acids Compounds (F.A.G.) Mouthwash |
| Stannous Fluoride (SF) | Active comparator | Individuals taking SF mouthwash Receives: Drug: Stannous Fluoride (SF) Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline; 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Sep 2021
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Pietropaoli, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977778
- Sponsor's protocol ID
- 77593/2021
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness in Dental Plaque Reduction of Two Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride: a Comparative Study
- ClinicalTrials.gov ID
- NCT04977778
- Acronym / sponsor ID
- 77593/2021
- Conditions
- Gingivitis, Gingival Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatty Acids Compounds (FAG) | Active comparator | Drug: Fatty Acids Compounds (F.A.G.) MouthwashIndividuals taking FAG mouthwash |
| Stannous Fluoride (SF) | Active comparator | Drug: Stannous Fluoride (SF) MouthwashIndividuals taking SF mouthwash |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (4 listed)
- Smoking
- Drugs prior month
- Dental hygiene <6 months
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatty Acids Compounds (F.A.G.) MouthwashFatty Acids Compounds (F.A.G.) Mouthwash | Drug | Fatty Acids Compounds (FAG) |
| Stannous Fluoride (SF) MouthwashStannous Fluoride (SF) Mouthwash | Drug | Stannous Fluoride (SF) |
Primary outcome
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
1 secondary outcome
Bleeding on Probing
Time frame: Baseline; 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatty Acids Compounds (F.A.G.) Mouthwash and Stannous Fluoride (SF) Mouthwash in people with Gingivitis and Gingival Diseases, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque score (time frame: Baseline; 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.