Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula and 3) that these mouthrinses have no negative microbiological effects, and they control total bacterial loads.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitat Internacional de Catalunya
• Collaborators: Dentaid; Dentaid SL
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

• 18-30 years

• Good overall health without medical history or medications that could interfere with the study conduct.

• Minimum of 6 teeth per quadrant.

• Absence of probing depths ≥4mm.

Exclusion Criteria:

• Allergy to CHX or to CPC.

• Continuous use of CHX or of any other oral antiseptic in the months prior to the study.

• Any adverse medical background or long-term medications that could affect gingival conditions.

• Having taken antibiotics in the previous three months.

• Moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(Van der Weijden et al. 1994).

• Pregnancy or breastfeeding.

• Smokers of more than 5 cigarettes per day.

• Orthodontic appliances.

• Fixed or removable prostheses.

• Systemic diseases that increase the risk for gingival diseases (diabetes mellitus, immunosuppression).

• Severe dental crowding.