Oral Malodour and Periodontal Disease-related Parameters

This study has been completed.
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01234948
First received: November 3, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

The primary aim of the current study was to determine the association between halitosis detection (presence or absence) and periodontal status in non-smoking subjects, and also assess whether halitosis recordings were related to periodontal clinical parameters, tongue coating and quantities of two putative periodontal pathogens on the posterior region of the tongue determined by real-time PCR. Secondary, halitosis recordings were compared among subjects with chronic periodontitis, chronic generalized gingivitis and periodontal health.


Condition
Halitosis
Periodontitis
Gingivitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Oral Malodour and Periodontal Disease-related Parameters. Clinical and Real-time PCR Findings

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Halitosis presence [ Time Frame: At a single time point ] [ Designated as safety issue: No ]
    Subjects were designated as halitosis positive (+) when either the organoleptic score of the whole mouth air was two or more, and/or the readings of the Halimeter® exceeded 140 p.p.b.


Secondary Outcome Measures:
  • Tongue coating [ Time Frame: At a single time point ] [ Designated as safety issue: No ]

    Assessment of tongue coating:

    The Winkel Tongue Coating Index (Winkel et al., 2003) was visually determined by dividing the dorsum of the tongue into sextants. A score between zero and two was given to each sextant according to the amount of deposits and these scores were added giving a total ranging from zero to 12.


  • Putative periodontal pathogens [ Time Frame: At a single time point ] [ Designated as safety issue: No ]
    A specimen was collected from the rear of the tongue dorsum for quantitative analysis of two putative periodontal pathogens, P. gingivalis and F. nucleatum, by real-time PCR.

  • Periodontal clinical indices [ Time Frame: At a single time point ] [ Designated as safety issue: No ]
    plaque index, clinical probing depth, clinical attachment levels and bleeding on probing.


Biospecimen Retention:   Samples With DNA

The tongue coating was collected with repeated strokes under relative pressure, using a sterile plastic microbiology loop of 10μl capacity from the terminal sulcus to the apex of the tongue. Samples were stored on ice in 1.5ml sterile Eppendorf tubes containing 0.4ml purified H2O. After vortex mixing for 30 seconds to evenly disperse the material the samples were stored at -70oC until required. The laboratory analysis was performed blind. Once thawed the tongue specimen was vortex mixed for 30 seconds and an aliquot was taken for subsequent use in the real-time PCR analysis. Lysates of samples were prepared by boiling the aliquot for 10 minutes after puncturing the cap with a fine sterile needle to prevent pressure build up.


Enrollment: 78
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic periodontitis patients
Chronic periodontitis patients had at least one site per quadrant with clinical probing depth (CPD) > 5mm and radiographic evidence of bone loss
Generalised chronic gingivitis patients
Generalised chronic gingivitis patients presented with bleeding on probing (BOP) at > 30% of sites, CPDs < 4mm and no evidence of bone loss
Periodontally healthy subjects
Healthy subjects had < 10% sites with BOP and no sites with CPD > 3mm

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Systemically healthy non-smokers were screened for oral halitosis in the Department of Periodontology, Aristotle University of Thessaloniki, Greece.

Criteria

Inclusion Criteria:

The clinical inclusion criteria were as follows:

(I) Chronic periodontitis patients had at least one site per quadrant with clinical probing depth (CPD) > 5mm and radiographic evidence of bone loss; (II) Generalised chronic gingivitis patients presented with bleeding on probing (BOP) at > 30% of sites, CPDs < 4mm and no evidence of bone loss; (III) Healthy subjects had < 10% sites with BOP and no sites with CPD > 3mm.

Exclusion Criteria:

Less than 20 teeth, smoking (during the previous year), presence of any systemic disease (e.g. diabetes mellitus, gastrointestinal disorders, etc.) including ENT complications, prescribed medication that can cause xerostomia based on the Greek National Formulary of drugs, full and/or partial dentures, heavily restored dentition, large carious cavities that can trap food remnants, pathology of the oral tissues (pericoronitis, dental / periodontal abscess, etc), antibiotic therapy within three months of recruitment, periodontal treatment within the last year, pregnancy or lactation.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234948

Locations
Greece
Dental School, Aristotle University
Thessaloniki, Greece, 54124
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Chair: Antonis Konstantinidis, Professor Department of Preventive Dentistry, Periodontology and Biology of Implants, Dental School, Aristotle University of Thessaloniki, Greece
  More Information

Publications:

Responsible Party: Dr Danae A. Apatzidou, Dental School, Aristotle University of Thessaloniki
ClinicalTrials.gov Identifier: NCT01234948     History of Changes
Other Study ID Numbers: self funded
Study First Received: November 3, 2010
Last Updated: November 3, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
Halitosis
VSC
Periodontitis
Gingivitis
Putative periodontal pathogens
Real-time PCR

Additional relevant MeSH terms:
Gingivitis
Halitosis
Periodontal Diseases
Periodontitis
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014