Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
NCT ID: NCT02194023
Last Updated: 2014-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2011-09-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Placebo (PCB)
Placebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water)
Placebo: PCB
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
0.12%NF
0.12% Chlorhexidine digluconate new formulation
0.12%NF
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
0.03%NF
0.03% Chlorhexidine digluconate new formulation
0.03%NF
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
PAT (Perio-Aid Treatment)
Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain)
PAT
Patients were asked to rinse every 12 hours, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
Interventions
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Placebo: PCB
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
0.12%NF
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
0.03%NF
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
PAT
Patients were asked to rinse every 12 hours, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
30 Years
ALL
Yes
Sponsors
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Dentaid SL
INDUSTRY
Universitat Internacional de Catalunya
OTHER
Responsible Party
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Carolina Mor
Master in periodontics by Universitat Internacional de Catalunya.
Principal Investigators
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Carolina Mor-Reinoso
Role: PRINCIPAL_INVESTIGATOR
Universitat Internacional de Catalunya
Locations
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UIC dental office, Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Countries
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Other Identifiers
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PER-ECL-2011-06-NF
Identifier Type: -
Identifier Source: org_study_id
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