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

University of Santiago de Compostela

Status and phase: Completed; Phase 1

Conditions: Saliva; Healthy; Biofilms

Treatments: Drug: 0.20% CHX and Cymenol gel on oral biofilm; Drug: 0.20% CHX and Cymenol gel on saliva; Drug: 0.20% CHX gel on saliva; Drug: 0.20% CHX gel on oral biofilm

Study type: Interventional

Funder types: Other

Identifiers

NCT06437262

2021-CE161

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Systemically healthy volunteers
• Age between 20-45 years
• Presence of minimum 24 permanent teeth
• No evidence of gingivitis or periodontitis (CPITN= 0)
• No presence of untreated caries at the start of the study

Exclusion criteria

• Smoker or ex-smoker
• Presence of dental protheses or orthodontic appliances
• Antibiotic treatment and/or routine use of oral antiseptics in the previous three months
• Presence of any systemic disease that could alter saliva production or composition

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

0.20% CHX gel

Active Comparator group

Description:

Participants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.

Treatment:

Drug: 0.20% CHX gel on oral biofilm

Drug: 0.20% CHX gel on saliva

0.20% CHX and Cymenol gel

Experimental group

Description:

Participants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.

Treatment:

Drug: 0.20% CHX and Cymenol gel on saliva

Drug: 0.20% CHX and Cymenol gel on oral biofilm