NCT06437262

Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva

Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine Gel on Oral Biofilm and Saliva

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Santiago de Compostela · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application.

Conditions

• Healthy
• Saliva
• Biofilms

Interventions

Type	Name	Description
DRUG	0.20% CHX gel on saliva	In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.
DRUG	0.20% CHX and Cymenol gel on saliva	In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.
DRUG	0.20% CHX gel on oral biofilm	Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.
DRUG	0.20% CHX and Cymenol gel on oral biofilm	Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-30
• Completion: 2023-07-31
• First posted: 2024-05-31
• Last updated: 2024-07-29

Locations

1 site across 1 country: Spain