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

  • Italy
      • Trieste, Italy
        • Ospedale Maggiore

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.
Drug: Chlorhexidine
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.
Drug: Chlorhexidine
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.
Drug: Chlorhexidine

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

dott. Lorenzo Bevilacqua

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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