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)
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|ClinicalTrials.gov Identifier: NCT01195493|
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was: Active, not recruiting
First Posted : September 6, 2010
Last Update Posted : December 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Other: Essential Oils solution Other: negative control solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||February 2010|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||September 2015|
|Experimental: test mouthrinse||
Other: 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: control group||
Other: negative control solution
this solution would be used twice per day (2 x 20 ml) following daily home care.
- Clinical and microbiological effects of an essential oils solution. [ Time Frame: at 3 months ]
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.
These effects are recorded, at baseline (prior to supportive treatment) and after 3 months (again prior to supportive treatment) by the same calibrated clinician
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195493
|University Hospital Ghent|
|Principal Investigator:||Hugo De Bruyn, PhD||University Hospital Ghent, Belgium|