Overview

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.