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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Staining Effect of Chlorhexidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

Interventions

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Chlorhexidine

Intervention Type DRUG

Eligibility Criteria

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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