Trial | NCT02194023  Report issue

Title

Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
Inhibition of de Novo Plaque Formation and Side Effects of Two New Mouthrinse Formulations: 0.12% and 0.03% Chlorhexidine Digluconate, Respectively, in a 4-day Non-brushing Model. A Triple-blind, Randomized Clinical Trial.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    chlorhexidine ...

  • Study Participants

    200
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.
Study Started
Sep 30
2011
Primary Completion
Jul 31
2013
Study Completion
Jul 31
2013
Last Update
Jul 18
2014
Estimate

Drug 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.

  • Other names: saline solution

Drug 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.

Drug 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.

Drug 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 names: Perio-Aid Treatment

Placebo (PCB) Placebo Comparator

Placebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water)

0.12%NF Experimental

0.12% Chlorhexidine digluconate new formulation

0.03%NF Experimental

0.03% Chlorhexidine digluconate new formulation

PAT (Perio-Aid Treatment) Active Comparator

Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain)

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.
No Results Posted