This trial is active, not recruiting.

Condition chronic periodontitis
Treatments essential oils solution, negative control solution
Phase phase 4
Sponsor University Hospital, Ghent
Collaborator Johnson & Johnson
Start date February 2010
End date August 2015
Trial size 50 participants
Trial identifier NCT01195493, 2009/552


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
essential oils solution
(Essential oils solution, Listerine®, Johnson & Johnson) to use twice a day (2 x 20 ml) following daily mechanical oral hygiene practices
(Active Comparator)
negative control solution
this solution would be used twice per day (2 x 20 ml) following daily home care.

Primary Outcomes

Clinical and microbiological effects of an essential oils solution.
time frame: at 3 months

Secondary Outcomes

Location of the gingival margin in relation to the cement-enamel junction measured to the nearest mm at 6 sites per tooth using a manual probe
time frame: at 3 months
Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe.
time frame: at 3 months
Bleeding on Probing evaluated 15 seconds following pocket probing
time frame: at 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Hugo De Bruyn, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.