Clinical and Microbiological Effects of an Essential Oils Solution Used as an Adjunct to Daily Oral Hygiene Practices in Chronic Periodontitis Patients in Supportive Care (Listerine)

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis

Treatments: Other: negative control solution; Other: Essential Oils solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01195493

2009/552

Details and patient eligibility

About

Chronic periodontitis is a common infectious disease characterized by progressive attachment loss and alveolar bone resorption eventually resulting in tooth loss. The ultimate goal of periodontal therapy is to prevent this endpoint. At least when a strict supportive care program is implemented following active therapy, subsequent tooth loss is limited to a mean of about 0.1 per patient per year. In contrast, three to six times as many teeth may be lost if the disease is left untreated.

The objective of supportive care is to prevent disease recurrence, which is accomplished by strict home care and professional plaque control at regular intervals depending on the patient's needs. Evidently, not all patients are optimally compliant in terms of plaque control. Therefore, chemical aids could be administered to supplement mechanical plaque removal.

Essential oils solutions containing menthol, thymol, methyl salicylate and eucalyptol as active agents may be more appropriate to supplement daily home care. Clinical studies have shown an additional anti-plaque and anti-gingivitis effect over mechanical plaque control without relevant side effects in healthy subjects and gingivitis patients.

Recently, significant reductions of periodontopathogens in the subgingival biofilm have been shown in periodontitis patients following subgingival irrigation using an essential oils solution. In addition, mouthrinsing on a daily basis seemed to substantially alter the subgingival microflora towards a less pathogenic one in gingivitis and periodontitis patients. Even though these are interesting findings, they should be considered exploratory since they relate to a small number of patients observed for only two weeks.

The goal of the present study was to thoroughly document the clinical and microbiological effects of an essential oils solution used on a daily basis for 3 months as an adjunct to mechanical plaque control measures in a large number of chronic periodontitis patients in supportive care.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of at least one 4 mm pocket per quadrant
• Patient in maintenance care for at least one year

Exclusion criteria

• Presence of 7 mm pockets or more
• Use of antibiotics within 3 months prior to the study
• Patients undergoing orthodontic therapy
• Patients wearing removable partial dentures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

test mouthrinse

Experimental group

Treatment:

Other: Essential Oils solution

control group

Active Comparator group

Treatment:

Other: negative control solution