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Tests treatment safety and results for Gingivitis
Official title Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents.
ClinicalTrials.gov ID: NCT06671106
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate if the adjunctive use of an amine and zinc lactate - containing mouthrinse may give significant benefits in the home-based treatment of plaque-induced gingivitis in adolescents. The study is based on the following hypothesis: the periodontal conditions of participants affected by gingivitis will significantly benefit from the implementation of the self-performed plaque control regimen (consisting of manual toothbrush and amine and zinc lactate toothpaste) with an amine and zinc lactate - containing mouthrinse.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 14
You may be able to join if
- systemically healthy;
- eligible for oral care provision by Regional Health Service due to low socio-economic status;
- at least 16 fully erupted teeth (excluding third molars);
- diagnosed with plaque-induced gingivitis (G) or periodontal health (PH) according to the World Workshop case definitions (Trombelli et al. 2018...
- willing to participate in the study and capable to fully understand and comply with the study procedures (including questionnaire reading and...
You likely can't join if
- pregnant or lactating;
- current smoking;
- motor and/or cognitive deficit impairing compliance with the study intervals or procedures;
- legal guardian not willing to either allow for subject participation in the study or ensure adherence with the study procedures;
- teeth with developmental defects (e.g., enamel pearls/projections);
- untreated oral lesions, including dental caries or endodontic lesions;
See the full eligibility criteria
- systemically healthy;
- eligible for oral care provision by Regional Health Service due to low socio-economic status;
- at least 16 fully erupted teeth (excluding third molars);
- diagnosed with plaque-induced gingivitis (G) or periodontal health (PH) according to the World Workshop case definitions (Trombelli et al. 2018, Chapple et al. 2018);
- willing to participate in the study and capable to fully understand and comply with the study procedures (including questionnaire reading and filling).
- pregnant or lactating;
- current smoking;
- motor and/or cognitive deficit impairing compliance with the study intervals or procedures;
- legal guardian not willing to either allow for subject participation in the study or ensure adherence with the study procedures;
- teeth with developmental defects (e.g., enamel pearls/projections);
- untreated oral lesions, including dental caries or endodontic lesions;
- fixed or removable orthodontic appliances or scheduled for orthodontic therapy with a timing not compatible with the experimental phase;
- use of antibiotics in the previous 3 months;
- use of medications that affect the size of the gingival tissues, such as phenytoin, sodium valproate, certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), and...
- conditions (e.g., Sjögren's syndrome, anxiety, poorly controlled diabetes) or medications (e.g., antihistamines, decongestants, antidepressants) that are associated with hyposalivation.
The study team makes the final eligibility decision.
Where it's taking place
- Ferrara, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ferrara, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.