Completed

NCT Number: NCT02132546

Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Oral 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Staining Effect of Chlorhexidine

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale Maggiore

Trieste, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine

Drug

Primary outcomes

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.)

Sponsors and collaborators

Lead sponsor

dott. Lorenzo Bevilacqua

Other

Registry information

Official study title

Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Periodontal Flap Surgery: a Prospective Randomized Clinical Trial

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: May 7, 2014
Registry last updated: May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.