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

NCT ID: NCT01195493

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

test mouthrinse

Group Type: EXPERIMENTAL

Essential Oils solution

Intervention Type: OTHER

(Essential oils solution, Listerine®, Johnson \& Johnson) to use twice a day (2 x 20 ml) following daily mechanical oral hygiene practices

control group

Group Type: ACTIVE_COMPARATOR

negative control solution

Intervention Type: OTHER

this solution would be used twice per day (2 x 20 ml) following daily home care.

Interventions

Essential Oils solution

(Essential oils solution, Listerine®, Johnson \& Johnson) to use twice a day (2 x 20 ml) following daily mechanical oral hygiene practices

Intervention Type: OTHER

negative control solution

this solution would be used twice per day (2 x 20 ml) following daily home care.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugo De Bruyn, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ghent, Belgium

Locations

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

Related Links

http://www.uzgent.be

website University Hospital Ghent, Belgium

Other Identifiers

2009/552

Identifier Type: -

Identifier Source: org_study_id