NCT01580943

Brief Summary

The purpose of this study was to compare the antiplaque efficacy of a 0,12% chlorhexidine and 0,05% cetyl-pyridinium chloride mouth rinse (Perio-aid®) with a 0,2% chlorhexidine non-alcohol base mouth rinse (Corsodyl Care®).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

Same day

First QC Date

April 16, 2012

Last Update Submit

April 20, 2012

Conditions

Dental Plaque

Keywords

ChlorhexidineCetyl pyridinium chlorideMouth rinseAntiplaque EfficacySelf EfficacyTaste SweetSide Effects

Outcome Measures

Primary Outcomes (1)

  • antiplaque efficacy

    antiplaque efficacy of two chlorhexidine mouth rinses: 0,12% chlorhexidine with 0,05% cetyl-pyridinium chloride mouth rinse (Perio-aid®) and a 0,2% chlorhexidine alcohol free mouth rinse (Corsodyl Care®) At baseline, all participants received a through supragingival dental prophylaxis to remove all stain, calculus and plaque. After 72h all participants were disclosed with a 1% erythrosine solution and the plaque in both groups was recorded at six sites per tooth on a 5-point scale using the Quigley \& Hein (1962) plaque index as modified by Turesky et al. (1970).

    72 hours

Secondary Outcomes (2)

  • taste

    72 hours

  • Side Effects

    72h

Study Arms (2)

Antiplaque Efficacy

ACTIVE COMPARATOR

This study was designed as a randomized, two group parallel, double-blind, 3-day non-brushing clinical trial. The sample size (50 participants) was determined using similar studies, making it a convenience sample. Over a 72-h experimental non-brushing period, subjects abstained from all forms of mechanical oral hygiene and one group (test) used an 0.12% CHX mouthrinse with 0.05% CPC (Perioaid®), twice daily for 30 seconds and the other group (positive control) used a 0.2% CHX mouthrinse alcohol free (Corsodyl® Care), twice daily for 60 seconds.

Drug: Chlorhexidine

Taste and Side Effects

ACTIVE COMPARATOR

All subjects received a questionnaire using a visual analogue scale designed to evaluate their taste to the mouthrinse, which they had used (What is your opinion concerning the taste of the mouth rinse?). Subjects marked a point on a 10 cm long uncalibrated line with the negative extreme response (0) on the left and the positive extreme (10) at the right end. Then, they were also asked about side effects in an open answer ("Did you feel any side effects caused by mouth rinse?", "If so, what are they?").

Drug: Chlorhexidine

Interventions

ChlorhexidineDRUG

Over a 72-h experimental non-brushing period, subjects abstained from all forms of mechanical oral hygiene and one group (test) used an 0.12% CHX mouthrinse with 0.05% CPC (Perioaid®), twice daily for 30 seconds and the other group (positive control) used a 0.2% CHX mouthrinse alcohol free (Corsodyl® Care), twice daily for 60 seconds. These regimens are suggested by the manufacturers in the instructions

Also known as: 0,12% CHX with 0,05% CPC (Perioaid®), 0,2% CHX non-alcohol base (Corsodyl® Care)
Antiplaque Efficacy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good general health without a medical history or medication that might interfere with the conduct of the study
  • Dentition with at least 24 teeth (minimum of five teeth per quadrant)
  • Periodontal health, pockets \< 5mm

You may not qualify if:

  • Pregnant women or in lactation
  • Participants with orthodontic or removable dental appliances
  • Known allergies to CHX, CPC or to another ingredient of the mouth rinses
  • Systemic antibiotic intake in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina Dentária da Universidade do Porto

Porto, Porto District, 4200-393, Portugal

Location

Related Links

MeSH Terms

Conditions

Dental Plaque

Interventions

ChlorhexidineEthanolAlkalies

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsAlcoholsInorganic Chemicals

Study Officials

  • Daniel Alves, DDS

    Faculdade de Medicina Dentária da Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 19, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2011

Study Completion

March 1, 2012

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

PT(1)