Trial document

This trial has been registered retrospectively.
drksid header


Trial Description

start of 1:1-Block title


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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017309
  •   2019/06/04
  •   [---]*
  •   yes
  •   Approved
  •   68/2019, Ethik-Kommission der Universität Witten/Herdecke
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J44.8 -  Other specified chronic obstructive pulmonary disease
end of 1:N-Block indications
start of 1:N-Block interventions

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).
end of 1:N-Block interventions
start of 1:1-Block design


  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   Actual
  •   2019/04/16
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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)

end of 1:1-Block exclusion criteria
start of 1:n-Block 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
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Kliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr. med.  Wolfram  Windisch 
    • Ostmerheimer Str.200
    • 51109  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Kliniken der Stadt Köln
    • Mr.  Dr. med.  Daniel  Majorski 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • 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
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.