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

Phase 2

Completed

• Conditions: Staining Effect of Chlorhexidine
• Interventions: Drug: Chlorhexidine

• Registration Number: NCT02132546
• Lead Sponsor: dott. Lorenzo Bevilacqua

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-10
• Study Completion: 2012-09
• Status Verified: 2014-04
• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-02
• Last Update Submitted: 2014-05-02
• Study First Posted: 2014-05-07
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine 0,2%	Chlorhexidine	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.
Chlorhexidine 0,2% with ADS	Chlorhexidine	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.
Chlorhexidine 0,12%	Chlorhexidine	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.

Primary Outcome Measures

Name	Time	Method
Change in ΔE before and after the use of chlorhexidine	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.)

Trial Locations

Locations (1)

Ospedale Maggiore; 🇮🇹 Trieste, Italy