Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07415733
Brief Summary:
The primary objective of this clinical study is to evaluate the impact on gingival health when participants switch to a fluoride toothpaste without gum-health actives for 4 weeks after using a proven gum-health toothpaste for 13 weeks.
Detailed Description:
This is a double-blind, randomized, controlled, parallel design study. A minimum of 150 participants (75 per group) will be enrolled according to the inclusion and exclusion criteria. The accepted participants will be randomly allocated to one of the two test products, which they will use at home twice daily for 13 weeks, followed by a switch to use a fluoride toothpaste without gum-health actives (the same formulation as the negative control) for an additional 4 weeks. Dental assessments of gingival condition, plaque levels and gingival bleeding will be performed at baseline, Weeks 4, 13 and 17. Gingival crevicular fluid (GCF) samples will be taken to detect biomarkers, and supragingival plaque samples will be collected to evaluate changes in microbial species relevant to gingival health. The Oral Health Impact Profile applied to Periodontal Disease (OHIP-14-PD) questionnaire will also be administered.
Study:
NCT07415733
Study Brief:
Protocol Section:
NCT07415733