Anti-staining Efficacy of Anti-Discoloration System (ADS)... | NCT02709824

Studies
Anti-staining Efficacy of Anti-Discoloration System (ADS) Added to Chlorhexidine (CHX)

NCT02709824

Sponsor

University of Milan

Status

Completed

Last Update Posted

Mar 22, 2016Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

Adverse Effect

Interventions

Chlorhexidine gluconate with ADS
Chlorhexidine gluconate without ADS

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Mar 11, 2016

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2016

Last Update Posted Date

Mar 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ANDREA SARDELLA, Associate Professor, University of MilanPrincipal Investigator

Lead Sponsor

University of MilanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic (CIE L*a*b* data analysis with DeltaE evaluation) and questionnaire-based analyses will be recorded. Immediate visual analysis of tooth pigmentation will be evaluated by volunteer him/herself, using a mirror, and by a single dentist soon after the end of each treatment. Participants will indicate the presence/absence of dental pigmentation, and to quantify it with a numeric scale (0= no pigmentation to 10= very strong pigmentation).

These analyses will be performed 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 "late" phase, a long-term subjective evaluation of dental discoloration will be obtained by means of the visual analysis of clinical photograph and new questionnaires. After 6 months from clinical trial (second stage of the study), frontal dental images of volunteers, collected during the first phase, will be printed on photographic paper and, then, visually analyzed, in blind, by the 22 volunteers themselves, as well as by 14 dentists and 13 oral hygienists ad hoc recruited. Dentists and oral hygienists, in particular, will be asked to observe two images of all the 22 subjects, i.e. after treatment with A or B mouthwash, and to answer to the question: "Which picture shows the most pigmented teeth?" Possible answers will be: "A, or B or no difference between the two images". Pigmentation will be also quantified using the numeric scale (0= no pigmentation to 10=strong pigmentation).

The observer will be not instructed in how the color of the teeth should appear in case of CHX pigmentation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Chlorhexidine gluconate with ADS	Drug	Oral rinsing, twice a day, for 21 days	Chlorhexidine gluconate with ADS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dental Staining - spectroscopic evaluation	dental color before and after the two treatments	21 days

Secondary Outcomes

Measure	Description	Time Frame
Dental Staining - visual evaluation	dental color before and after the two treatments	21 days
Dental Staining - visual evaluation on images	dental color before and after the two treatments

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antonio Carrassi, MD	University of Milan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Milan		Milan	Italy	20142	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18422695	Background	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.
16451475	Background