A 2-year clinical study to investigate the effect of two oral gels on the durability and contour of gingival tissue

Procter & Gamble (United States)0 个研究点目标入组 195 人开始时间: 2021年12月22日最近更新: 2022年1月4日

适应症

试验速览

暂无简介。

•1. Give written informed consent;
•2. Agree to be contacted for appointment reminders;
•3. Be 18 to 65 years of age;
•4. Be in good general health;
•5. Have up to two test teeth with buccal gum recessions (1-5mm & present keratinized gingiva) which are not related to periodontal disease, periodontal treatment, malocclusion, use of orthodontic appliance or partial denture do not have class V restorations or root caries, not
•crowns, and are preferably in the maxillary arch;
•6. Agree not to participate in any other clinical study for the duration of this study;
•7. Agree to continue to use their current type of toothbrush and dentifrice for the study duration;
•8. Agree not to add any other oral hygiene products, including whitening products, and not to change the rinse or interdental hygiene device(s) if they are currently using one until the study ends (regular use of CHX rinses are not allowed);
•9. Agree to follow study procedures and to return for all scheduled clinical visits;
•10. Agree to refrain from elective dentistry, including refraining from a dental prophylaxis any time within the 4 weeks prior to Months 6, 12, 18 and 24 visits and agree to report any dentistry received any time during the course of the study;
•11. Agree to refrain from orthodontic treatment during the study duration.

•1. Participating in another oral care clinical study within the last 30 days;
•2. Tobacco usage;
•3. Having a disease, illness or condition that could be expected to interfere with examination procedures or might influence results or preclude the subject safely completing the study (e.g. AIDS, diabetes);
•4. Presence or history of periodontal disease (at least 2 pockets 6mm in two quadrants);
•5. Currently taking any drug that can cause gum overgrowth (i.e., Nifedipine, Hydantoin, Ciclosporin);
•6. Bad oral hygiene;
•7. Taking a vitamin A supplement or using retinoid dermal application such as a cosmetic product;
•8. Allergy or sensitivity to dyes, benzyl alcohol, sunflower seed oil, BHA (Butylatedhydroxyanisole), Polysorbate 20;
•9. Allergy or sensitivity to Vitamin A/retinol;
•10. Any physical limitations that might preclude normal oral hygiene procedures;
•11. Self-reported pregnancy or breast feeding;
•12. Requiring any type of medication prior to dental procedures;
•13. Major hard or soft tissue lesions or trauma or carious lesions requiring restorative treatment or actively in treatment for periodontitis;
•14. Gingival recession that was a consequence of periodontal treatment or chronic periodontitis;
•15. Having a dental prophylaxis any time within the 4 weeks prior to study initiation;
•16. Actively in orthodontic treatment or having completed an orthodontic treatment any time within the 3 months prior to study initiation.

发起方

Procter & Gamble (United States)