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

NCT01195493 | Completed Phase 4

• 1 other identifier: 2009/552
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  at 3 months

Secondary Outcomes (3)

• 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

  at 3 months

• Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe.

  at 3 months

• Bleeding on Probing evaluated 15 seconds following pocket probing

  at 3 months

Study Arms (2)

test mouthrinse

EXPERIMENTAL

Other: Essential Oils solution

control group

ACTIVE COMPARATOR

Other: negative control solution

Interventions

Essential Oils solution OTHER

(Essential oils solution, Listerine®, Johnson \& Johnson) to use twice a day (2 x 20 ml) following daily mechanical oral hygiene practices

test mouthrinse

negative control solution OTHER

this solution would be used twice per day (2 x 20 ml) following daily home care.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of at least one 4 mm pocket per quadrant
• Patient in maintenance care for at least one year

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Johnson & Johnson: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website University Hospital Ghent, Belgium

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hugo De Bruyn, PhD

  University Hospital Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: July 31, 2015
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)