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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01195493
First received: September 3, 2010
Last updated: February 1, 2013
Last verified: February 2013

September 3, 2010
February 1, 2013
February 2010
August 2013   (final data collection date for primary outcome measure)
Clinical and microbiological effects of an essential oils solution. [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

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

to evaluate clinical and microbiological effects of an essential oils solution [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

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

Complete list of historical versions of study NCT01195493 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe. [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • Bleeding on Probing evaluated 15 seconds following pocket probing [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: No ]
  • - Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe. [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • Bleeding on Probing evaluated 15 seconds following pocket probing [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Chronic Periodontitis
  • 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
  • Other: negative control solution
    this solution would be used twice per day (2 x 20 ml) following daily home care.
  • Experimental: test mouthrinse
    Intervention: Other: Essential Oils solution
  • Active Comparator: control group
    Intervention: Other: negative control solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
September 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01195493
2009/552
No
University Hospital, Ghent
University Hospital, Ghent
Johnson & Johnson
Principal Investigator: Hugo De Bruyn, PhD University Hospital Ghent, Belgium
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP