NCT02194023

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

July 13, 2014

Last Update Submit

July 17, 2014

Conditions

Dental PlaqueSide Effects

Keywords

chlorhexidine digluconategingivitiscetylpyridinium chloridemouthrinsedental plaquede novoin vivo

Outcome Measures

Primary Outcomes (1)

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

    Baseline to 4 days.

Study Arms (4)

Placebo (PCB)

PLACEBO COMPARATOR

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

Drug: Placebo: PCB

0.12%NF

EXPERIMENTAL

0.12% Chlorhexidine digluconate new formulation

Drug: 0.12%NF

0.03%NF

EXPERIMENTAL

0.03% Chlorhexidine digluconate new formulation

Drug: 0.03%NF

PAT (Perio-Aid Treatment)

ACTIVE COMPARATOR

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

Drug: PAT

Interventions

Placebo: PCBDRUG

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.

Also known as: saline solution
Placebo (PCB)
0.12%NFDRUG

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
0.03%NFDRUG

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
PATDRUG

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.

Also known as: Perio-Aid Treatment
PAT (Perio-Aid Treatment)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UIC dental office, Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Dental PlaqueGingivitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Carolina Mor-Reinoso

    Universitat Internacional de Catalunya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in periodontics by Universitat Internacional de Catalunya.

Study Record Dates

First Submitted

July 13, 2014

First Posted

July 18, 2014

Study Start

September 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

ES(1)