Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents.

Launched by UNIVERSITÀ DEGLI STUDI DI FERRARA · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether using a special mouthrinse that contains amine and zinc lactate can help treat gingivitis, a common gum disease, in teenagers. The researchers believe that combining this mouthrinse with regular brushing and flossing will lead to healthier gums for those with gingivitis. To find out if this is true, they will compare the gum health of 100 adolescents with gingivitis to 50 adolescents who have healthy gums over a period of six months. Participants will be asked to follow specific oral hygiene routines and attend several check-ups to monitor their progress.

To join the study, teens must be in good health, have at least 16 teeth, and have been diagnosed with gingivitis. They should also be willing to follow the study rules and complete questionnaires about their oral health. Those who are pregnant, smoke, or have certain health conditions that could interfere with the study are not eligible. Participants can expect to visit the clinic multiple times for assessments and will play an important role in helping researchers understand how effective this mouthrinse can be in improving gum health.

Gender

ALL

Eligibility criteria

• Inclusion 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).
• Exclusion Criteria:
• • 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 immune-regulating drugs (e.g., cyclosporine);
• • conditions (e.g., Sjögren's syndrome, anxiety, poorly controlled diabetes) or medications (e.g., antihistamines, decongestants, antidepressants) that are associated with hyposalivation.