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

dott. Lorenzo Bevilacqua

Status and phase: Completed; Phase 2

Conditions: Staining Effect of Chlorhexidine

Treatments: Drug: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02132546

AAA-0001-TS

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 3 patient groups

Chlorhexidine 0,2%

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine

Chlorhexidine 0,2% with ADS

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine

Chlorhexidine 0,12%

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine