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

NCT02132546 | Completed Phase 2

• 1 other identifier: AAA-0001-TS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Staining Effect of Chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Change in ΔE before and after the use of chlorhexidine

  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

Study Arms (3)

Chlorhexidine 0,2%

EXPERIMENTAL

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

Chlorhexidine 0,2% with ADS

EXPERIMENTAL

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

Chlorhexidine 0,12%

EXPERIMENTAL

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

Interventions

Chlorhexidine DRUG

Chlorhexidine 0,12%; Chlorhexidine 0,2%; Chlorhexidine 0,2% with ADS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Smokers
• Allergy to CHX
• Lack of written informed consent

Sponsors & Collaborators

• dott. Lorenzo Bevilacqua: lead

Study Sites (1)

Ospedale Maggiore

Trieste, Italy, Italy

Location

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, MS

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 7, 2014
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: September 1, 2012
• Last Updated: May 7, 2014

Record last verified: 2014-04

Locations

IT (1)