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Oral Malodour and Periodontal Disease-related Parameters

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234948
First Posted: November 4, 2010
Last Update Posted: November 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aristotle University Of Thessaloniki
  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 ]
    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 ]

    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): 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:
Donaldson AC, Riggio MP, Rolph HJ, Bagg J, Hodge PJ. Clinical examination of subjects with halitosis. Oral Dis. 2007 Jan;13(1):63-70.
Winkel EG, Roldán S, Van Winkelhoff AJ, Herrera D, Sanz M. Clinical effects of a new mouthrinse containing chlorhexidine, cetylpyridinium chloride and zinc-lactate on oral halitosis. A dual-center, double-blind placebo-controlled study. J Clin Periodontol. 2003 Apr;30(4):300-6.
Roldán S, Winkel EG, Herrera D, Sanz M, Van Winkelhoff AJ. The effects of a new mouthrinse containing chlorhexidine, cetylpyridinium chloride and zinc lactate on the microflora of oral halitosis patients: a dual-centre, double-blind placebo-controlled study. J Clin Periodontol. 2003 May;30(5):427-34.
Liu XN, Shinada K, Chen XC, Zhang BX, Yaegaki K, Kawaguchi Y. Oral malodor-related parameters in the Chinese general population. J Clin Periodontol. 2006 Jan;33(1):31-6.
Murata T, Yamaga T, Iida T, Miyazaki H, Yaegaki K. Classification and examination of halitosis. Int Dent J. 2002 Jun;52 Suppl 3:181-6.
Nachnani S, Majerus G, Lenton P, Hodges J, Magallanes E. Effects of training on odor judges scoring intensity. Oral Dis. 2005;11 Suppl 1:40-4.
Saad S, Greenman J, Duffield J, Sudlow K. Use of n-butanol as an odorant to standardize the organoleptic scale of breath odour judges. Oral Dis. 2005;11 Suppl 1:45-7.
Aaronson N, Alonso J, Burnam A, Lohr KN, Patrick DL, Perrin E, Stein RE. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002 May;11(3):193-205. Review.
Yoshida Y, Suzuki N, Nakano Y, Shibuya K, Ogawa Y, Koga T. Distribution of Actinobacillus actinomycetemcomitans serotypes and Porphyromonas gingivalis in Japanese adults. Oral Microbiol Immunol. 2003 Jun;18(3):135-9.
Kato H, Yoshida A, Awano S, Ansai T, Takehara T. Quantitative detection of volatile sulfur compound- producing microorganisms in oral specimens using real-time PCR. Oral Dis. 2005;11 Suppl 1:67-71. Erratum in: Oral Dis. 2009 Jan;15(1):120.
Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9.
Rosenberg M, Kulkarni GV, Bosy A, McCulloch CA. Reproducibility and sensitivity of oral malodor measurements with a portable sulphide monitor. J Dent Res. 1991 Nov;70(11):1436-40.

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
First Submitted: November 3, 2010
First Posted: November 4, 2010
Last Update Posted: November 4, 2010
Last Verified: November 2010

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

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


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