NCT02709824

Brief Summary

Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes. A prospective, cross-over, randomized clinical trial will be carried out in triple blind to compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the study includes two sequential stages: in the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic and questionnaire-based analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A wash-out period between the cycles of 21 days will be performed. In the second phase, a long-term (after 6 months) subjective evaluation of dental discoloration will be obtained by means of clinical photograph visual analysis and new questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

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

December 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

March 11, 2016

Last Update Submit

March 18, 2016

Conditions

Adverse Effect

Outcome Measures

Primary Outcomes (1)

  • Dental Staining - spectroscopic evaluation

    dental color before and after the two treatments

    21 days

Secondary Outcomes (2)

  • Dental Staining - visual evaluation

    21 days

  • Dental Staining - visual evaluation on images

    21 days of treatments, re-analysis of images after 6 months from the end of the trial

Study Arms (2)

Chlorhexidine gluconate with ADS

ACTIVE COMPARATOR

Chlorhexidine 0.12% plus Anti-Discoloration System Mouthwash

Drug: Chlorhexidine gluconate with ADS

Chlorhexidine gluconate without ADS

ACTIVE COMPARATOR

Chlorhexidine 0.12% Mouthwash

Drug: Chlorhexidine gluconate without ADS

Interventions

Chlorhexidine gluconate with ADSDRUG

Oral rinsing, twice a day, for 21 days

Also known as: Curasept (0.12% Chlorhexidine gluconate with ADS)
Chlorhexidine gluconate with ADS
Chlorhexidine gluconate without ADSDRUG

Oral rinsing, twice a day, for 21 days

Also known as: Dentosan (0.12% Chlorhexidine gluconate without ADS)
Chlorhexidine gluconate without ADS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to be free from oral mucosa conditions affecting its integrity
  • to avoid drug or mouthwash intake during the study and in the previous month

You may not qualify if:

  • specific allergy to mouthrinses
  • presence of periodontitis
  • frequent use of Chlorhexidine-based oral hygiene products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Milan

Milan, Italy, 20142, Italy

Location

Related Publications (4)

  • Cortellini P, Labriola A, Zambelli R, Prato GP, Nieri M, Tonetti MS. Chlorhexidine with an anti discoloration system after periodontal flap surgery: a cross-over, randomized, triple-blind clinical trial. J Clin Periodontol. 2008 Jul;35(7):614-20. doi: 10.1111/j.1600-051X.2008.01238.x. Epub 2008 Apr 16.

    PMID: 18422695BACKGROUND

  • Bernardi F, Pincelli MR, Carloni S, Gatto MR, Montebugnoli L. Chlorhexidine with an Anti Discoloration System. A comparative study. Int J Dent Hyg. 2004 Aug;2(3):122-6. doi: 10.1111/j.1601-5037.2004.00083.x.

    PMID: 16451475BACKGROUND

  • Solis C, Santos A, Nart J, Violant D. 0.2% chlorhexidine mouthwash with an antidiscoloration system versus 0.2% chlorhexidine mouthwash: a prospective clinical comparative study. J Periodontol. 2011 Jan;82(1):80-5. doi: 10.1902/jop.2010.100289. Epub 2010 Jul 27.

    PMID: 20653433BACKGROUND

  • Li W, Wang RE, Finger M, Lang NP. Evaluation of the antigingivitis effect of a chlorhexidine mouthwash with or without an antidiscoloration system compared to placebo during experimental gingivitis. J Investig Clin Dent. 2014 Feb;5(1):15-22. doi: 10.1111/jicd.12050. Epub 2013 Jun 14.

    PMID: 23766285BACKGROUND

MeSH Terms

Interventions

chlorhexidine gluconate

Study Officials

  • Antonio Carrassi, MD

    University of Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 16, 2016

Study Start

December 1, 2011

Primary Completion

February 1, 2012

Study Completion

July 1, 2012

Last Updated

March 22, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)