Clinical trial NCT01195493: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2010-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Clinical and microbiological effects of an essential oils solution.
timeFrame: at 3 months
Secondary outcomes:
measure: 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
timeFrame: at 3 months
measure: Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe.
timeFrame: at 3 months
measure: Bleeding on Probing evaluated 15 seconds following pocket probing
timeFrame: at 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Hugo De Bruyn, PhD
role: PRINCIPAL_INVESTIGATOR
References: