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

Primary Purpose

Dental Plaque, Side Effects

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Placebo: PCB
0.12%NF
0.03%NF
PAT
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Plaque focused on measuring chlorhexidine digluconate, gingivitis, cetylpyridinium chloride, mouthrinse, dental plaque, de novo, in vivo

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UIC dental office, Hospital General de Catalunya

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Active Comparator

Arm Label

Placebo (PCB)

0.12%NF

0.03%NF

PAT (Perio-Aid Treatment)

Arm Description

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

0.12% Chlorhexidine digluconate new formulation

0.03% Chlorhexidine digluconate new formulation

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

Outcomes

Primary Outcome Measures

Percentage of participants with greater reduction of plaque regrowth and side effects.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2014
Last Updated
July 17, 2014
Sponsor
Universitat Internacional de Catalunya
Collaborators
Dentaid SL
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1. Study Identification

Unique Protocol Identification Number
NCT02194023
Brief Title
Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya
Collaborators
Dentaid SL

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Side Effects
Keywords
chlorhexidine digluconate, gingivitis, cetylpyridinium chloride, mouthrinse, dental plaque, de novo, in vivo

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (PCB)
Arm Type
Placebo Comparator
Arm Description
Placebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water)
Arm Title
0.12%NF
Arm Type
Experimental
Arm Description
0.12% Chlorhexidine digluconate new formulation
Arm Title
0.03%NF
Arm Type
Experimental
Arm Description
0.03% Chlorhexidine digluconate new formulation
Arm Title
PAT (Perio-Aid Treatment)
Arm Type
Active Comparator
Arm Description
Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain)
Intervention Type
Drug
Intervention Name(s)
Placebo: PCB
Other Intervention Name(s)
saline solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.12%NF
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.03%NF
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PAT
Other Intervention Name(s)
Perio-Aid Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants with greater reduction of plaque regrowth and side effects.
Time Frame
Baseline to 4 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Mor-Reinoso
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
UIC dental office, Hospital General de Catalunya
City
Sant Cugat
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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