Status:
COMPLETED
Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
Lead Sponsor:
Universitat Internacional de Catalunya
Collaborating Sponsors:
Dentaid SL
Conditions:
Dental Plaque
Side Effects
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief 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 bette...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02194023
Start Date
September 1 2011
End Date
July 1 2013
Last Update
July 18 2014
Active Locations (1)
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1
UIC dental office, Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195