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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)

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Essential Oils solution
negative control solution
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Periodontitis focused on measuring Chronic periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

test mouthrinse

control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe.
Bleeding on Probing evaluated 15 seconds following pocket probing

Full Information

First Posted
September 3, 2010
Last Updated
December 14, 2022
Sponsor
University Hospital, Ghent
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT01195493
Brief 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
Acronym
Listerine
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 2010 (Actual)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Johnson & Johnson

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chronic periodontitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test mouthrinse
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Essential Oils solution
Intervention Description
(Essential oils solution, Listerine®, Johnson & Johnson) to use twice a day (2 x 20 ml) following daily mechanical oral hygiene practices
Intervention Type
Other
Intervention Name(s)
negative control solution
Intervention Description
this solution would be used twice per day (2 x 20 ml) following daily home care.
Primary Outcome Measure Information:
Title
Clinical and microbiological effects of an essential oils solution.
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe.
Time Frame
at 3 months
Title
Bleeding on Probing evaluated 15 seconds following pocket probing
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo De Bruyn, PhD
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent, Belgium

Learn more about this trial

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

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