- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132546
Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Oral Surgery: a Prospective Randomized Clinical Trial
May 2, 2014 updated by: dott. Lorenzo Bevilacqua
Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Periodontal Flap Surgery: a Prospective Randomized Clinical Trial
The aim of this clinical trial was to evaluate through a clinical spectrophotometric analysis the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery.
The efficacy of the products and the patient's opinion and acceptance were also assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Trieste, Italy
- Ospedale Maggiore
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Good general health conditions without a medical history of medication that might interfere with periodontal tissues
- Good plaque control (FMPS ≤ 25%) and low levels of infection (FMBS ≤ 25%)
- Need for periodontal surgery
Exclusion Criteria:
- Smokers
- Allergy to CHX
- Lack of written informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chlorhexidine 0,2%
After surgery, the patient was given instruction following the post-operative protocol.
Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash.
According to random assignment (random generator, www.random.org), the bottle contained 0.2% CHX.
|
|
Experimental: Chlorhexidine 0,2% with ADS
After surgery, the patient was given instruction following the post-operative protocol.
Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash.
According to random assignment (random generator, www.random.org), the bottle contained 0.2% CHX with ADS.
|
|
Experimental: Chlorhexidine 0,12%
After surgery, the patient was given instruction following the post-operative protocol.
Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash.
According to random assignment (random generator, www.random.org), the bottle contained 0.12% CHX.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ΔE before and after the use of chlorhexidine
Time Frame: Change from Baseline of ΔE after the use of chlorhexidine mouthrinses; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 1 week; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 2 weeks
|
Change in ΔE before and after the use of chlorhexidine (ΔE is a measurement used to indicate how much a color deviates from an accepted standard.
Perfect color has a ΔE of zero.)
|
Change from Baseline of ΔE after the use of chlorhexidine mouthrinses; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 1 week; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
April 30, 2014
First Submitted That Met QC Criteria
May 2, 2014
First Posted (Estimate)
May 7, 2014
Study Record Updates
Last Update Posted (Estimate)
May 7, 2014
Last Update Submitted That Met QC Criteria
May 2, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAA-0001-TS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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