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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
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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 ]
  2. Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe. [ Time Frame: at 3 months ]
  3. Bleeding on Probing evaluated 15 seconds following pocket probing [ Time Frame: at 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Johnson & Johnson
Investigators
Principal Investigator: Hugo De Bruyn, PhD University Hospital Ghent, Belgium

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01195493     History of Changes
Other Study ID Numbers: 2009/552
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
Chronic periodontitis

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions