Trial document





This trial has been registered retrospectively.
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  DRKS00017309

Trial Description

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Title

Pilot and Validation Study Periodontitis and CAT Score – Can the COPD assessment tool provide a valid statement on periodontitis risk and dental status?

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The CAT Score (COPD Assessment Test) by Jones et al. is a patient-centered, questionnaire to assess the current burden of disease in COPD patients, developed in 2009. It consists of eight elements (shortness of breath, cough, sputum production, wheeze, activity limitations, emotional well-being, sleep, energy / fatigue, use of rescue medication) [1] and allows points to be scored per element from 0-5. The questionnaire was developed because, despite the availability of clinical guidelines such as the GOLD classification, a significant number of patients did not reach the level of treatment success theoretically possible. [1] (Jones)
In recent years, the validity of this questionnaire has been confirmed in many scientific papers and correlations between the CAT score and the likelihood of exacerbation [2,3], depression [4,5], Mortality [6] as well as treatment response [7] was shown. To find out if even bad dental status correlates with this score is the aim of this study.

1. Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34(3):648-54.
2. Lee SD, Huang MS, Kang J, Lin CH, Park MJ, Oh YM, et al. The COPD assessment test (CAT) assists prediction of COPD exacerbations in high-risk patients. Respir Med. 2014;108(4):600-8.;
3. Pothirat C, Chaiwong W, Limsukon A, Deesomchok A, Liwsrisakun C, Bumroongkit C, et al. Detection of acute deterioration in health status visit among COPD patients by monitoring COPD assessment test score. Int J Chron Obstruct Pulmon Dis. 2015;10:277-82
4. Lee YS, Park S, Oh YM, Lee SD, Park SW, Kim YS, et al. Chronic obstructive pulmonary disease assessment test can predict depression: a prospective multi-center study. J Korean Med Sci. 2013;28(7):1048-54.
5. Silva Junior JL, Conde MB, de Sousa Correa K, da Silva C, da Silva Prestes L, Rabahi MF. COPD Assessment Test (CAT) score as a predictor of major depression among subjects with chronic obstructive pulmonary disease and mild hypoxemia: a case-control study. BMC Pulm Med. 2014;14:186.
6. Casanova C, Marin JM, Martinez-Gonzalez C, de Lucas-Ramos P, Mir-Viladrich I, Cosio B, et al. Differential Effect of Modified Medical Research Council Dyspnea, COPD Assessment Test, and Clinical COPD Questionnaire for Symptoms Evaluation Within the New GOLD Staging and Mortality in COPD. Chest. 2015;148(1):159-68.
7. Zhou A, Zhou Z, Peng Y, Zhao Y, Duan J, Chen P. The role of CAT in evaluating the response to treatment of patients with AECOPD. Int J Chron Obstruct Pulmon Dis. 2018;13:2849-58.

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Brief Summary in Scientific Language

Prospective cross-sectional study on diagnostic quality. Open, prospective, monocentric, cohort study to investigate the correlation between CAT score and poor dental status.

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Organizational Data

  •   DRKS00017309
  •   2019/06/04
  •   [---]*
  •   yes
  •   Approved
  •   68/2019, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   J44.8 -  Other specified chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   Survey of CAT (COPD Assessment Test) Score, DMFT (Decay-missing-filled teeth) Index, OHIP 14 (Oral Health Impact Profile) and PSI Score (Pneumonia Severity Index).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The sensitivity of the CAT (COPD Assessment Test) score to predict poor tooth status as measured by the DMFT (Decay-missing-filled index) index and PSI (Pneumonia severity index) score is examined. The data is collected during the outpatient presentation at the dentist. This marks the time of measuring the Primary endpoint. The study for the patient ends the same day the patients are approached. After successful data collection, the evaluation begins. The area under a prepared ROC (Receiver Operating Characteristic) curve will be analyzed to achieve a clinically useful recommendation in terms of sensitivity and specificity in using this tool. In addition, the positive predictive and negative predictive value is determined and the optimal cut-off value of the CAT score is calculated and discussed using Youden's index.

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Secondary Outcome

An analysis of the OHIP 14 questionnaire (Oral Health Impact Profile) will be conducted to determine if there is a decreased oral health associated quality of life in the panel examined in this study. This questionnaire will also be evaluated the same day the patients present themselves in the outpatient dental clinic, therefore marks the time of measuring the secondary endpoint. After successful data collection the questionnaires will be evaluated. For this purpose, the collected data is set in relation to existing norm values ​​and interpreted.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/04/16
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   99   Years
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Additional Inclusion Criteria

• Signed consent
• ≥20 Pack Years
• Patient age ≥40 years

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Exclusion Criteria

• Patient age <40 years
• Mental retardation
• Missing consent
• Patients who have received periodontal therapy in the last 6 months
• Patients who are taking medications (antibiotics) that have been shown to affect dental status
• Patients with other systemic diseases (HIV / tuberculosis / malignant events)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Kliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr. med.  Wolfram  Windisch 
    • Ostmerheimer Str.200
    • 51109  Köln
    • Germany
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    • Kliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr. med.  Wolfram  Windisch 
    • Ostmerheimer Str.200
    • 51109  Köln
    • Germany
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    • Kliniken der Stadt Köln
    • Mr.  Dr. med.  Daniel  Majorski 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Kliniken der Stadt Köln gGmbHLehrstuhl für PneumologieUniversität Witten/HerdeckeFakultät für Gesundheit/Department für Humanmedizin
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.