A Phase 4 interventional study of Essential Oils solution and negative control solution in Chronic Periodontitis, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Prevention
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 50 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
Other: Essential Oils solution
Other: negative control solution
(Essential oils solution, Listerine®, Johnson \& Johnson) to use twice a day (2 x 20 ml) following daily mechanical oral hygiene practices
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.
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
Time frame: at 3 months
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
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent