Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02754401 |
| Other study ID # |
337-13-18112013 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 18, 2016 |
| Last updated |
April 27, 2016 |
| Start date |
January 2014 |
| Est. completion date |
July 2014 |
Study information
| Verified date |
April 2016 |
| Source |
Renatus, Antonio Renatus, Dent., M.Sc |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Germany: Ethics Commission |
| Study type |
Interventional
|
Clinical Trial Summary
200 patients took part in the questionnaire and were examined using the PSI. Thereafter the
participants were divided into two groups, non-periodontitis persons (group 1; PSI 0-2) and
periodontitis persons (group 2; PSI 3-4). The answers were evaluated using a point system
ranging from 0 to 8, based on known periodontal risk factors and their assumed degree of
influence. Receiver-operating characteristic (ROC) curve analyses were applied to examine
the overall discriminatory power, sensitivity and specificity, and corresponding cut-off
points of the self-reported periodontal disease scale.
Description:
Materials and Methods
This clinical investigation was approved by the Ethics Commission at the Medical Faculty in
Leipzig (337-13-18112013). Before commencing the double-blind, controlled clinical trial (),
all study participants were informed of its content and the use of personal data and
confirmed their voluntary willingness to take part in writing.
Patients
A new questionnaire was used as part of a preliminary dental examination to interview a
total of 200 patients concerning the clinical indications and periodontal risk factors. The
clinical follow-up examination was conducted by the Periodontal Screening Index (PSI). To
include representative periodontitis patients a consecutive sampling was applied. The
participants were divided into two groups of non-periodontitis patients (group 1; PSI Code
0,1,2) and periodontitis persons (group 2; PSI Code 3 and 4) for the first PSI
classification (Perio 1). The sampling was finished until each group reached a number of
hundred patients. To reduce the so-called center effect [25] the patients were all unknown
to the examiners. Patients were also required to be at least 18 years to take part in the
study. Patients undergoing a periodontal treatment, pregnant and disabled persons were also
excluded from the study.
Periodontal Situation (PSI, PSR®)
The Periodontal Screening Index (PSI in Germany) or Periodontal Screening and Recording
(PSR®) [12,13] was registered based on a WHO probe (Morita, Kyoto, Japan). The set of teeth
was divided into sextants for the purpose of the investigation. The PSI scores (0 to 4) were
recorded: score 0=healthy, score 1=bleeding, score 2=supra-/subgingival calculus, score
3=probing depths from 3.5mm to max. 5.5mm, score 4=probing depths greater than 5.5mm. We
noted only the highest findings for each sextant. Persons with findings of code 0 to code 2
were classified as non-periodontitis persons (group 1), whereby codes 3 and 4 were
considered a probable periodontitis persons (group 2). Two additional PSI classifications
were defined in order to review the robustness of the screening test with respect to the
prevalent severity of periodontitis. Classification Perio 2 comprised persons with a PSI
code 0,1,2 and once code 3, indicating non-periodontitis, while persons recording two codes
3 or 4 on one occasion were periodontitis persons. In the third classification (Perio 3),
only such patients as exhibited at least one code 4 were considered as periodontitis
persons, while all others were evaluated as non-periodontitis persons.
All clinical recordings were performed by the same calibrated examiners. Examiners
calibration was performed as follows: five adults, not enrolled in the study, were evaluated
by the examiners on two separate occasions, 48 hours apart. Calibration was accepted if the
millimetre measurements at baseline and 48 hours later did not differ more than 10 percent.
Questionnaire
The questionnaire was initially prepared by a retrospective selection of suitable items
reviewed in current literature on the subject of periodontal risk factors and indicators.
Research was conducted using PubMed, whereby only articles written in English were included.
Systematic reviews and randomised, controlled studies were preferred. Based on this 16
questions were developed. The individual response options were assigned point values
extending from zero to eight, based on their assumed degree of influence on the periodontal
disease. To determine the correct wording and phrasing the questionnaire was given as a
pretest to 20 patients not included in the study.
Statistical analysis
Statistical evaluation was conducted using SPSS for Windows, Version 22.0 (SPSS Inc., NY,
U.S.A.) and BiAS. for Windows, Version 10.12. (epsilon-Verlag GbR, Hochheim Darmstadt,
Germany). The sample size (200 participants) was calculated with an expected standard
deviation of four score points, minimal different score point delta between 1.6 and 2,
p-value of 0.05 and a power of 0.8 [24]. The categorised data was evaluated based on the
Chi-squared test (question 2-6, 8-12, 15, 16), the precise test according to Fisher
(question 1, 7, 13, 14). A two-sided review of significance was applied to each of the
tests, whereby a p-value of <0.05 was assumed to be statistically significant for all
statistical tests.
The distribution of total score was reviewed according to the Kolmogorov-Smirnov test in
terms of normal distribution. The score did not exhibit a normal distribution
(Kolmogorov-Smirnov test: p<0.05). Furthermore the Mann-Whitney U-test was applied in the
comparison of scores based on the variety of periodontitis classifications (differentiated
consideration of periodontally diseased persons) and box plots were created to elucidate the
data.
ROC curves (receiver operating characteristic) were produced to illustrate sensitivity and
specificity. The area under the ROC curve (AUC), which in a test without forecast
reliability will be 0.5 and not more than 1, is a benchmark to measure forecast reliability.
The cut-off point was defined as beyond a sensitivity of at least 80% with the greatest
possible specificity in order to meet the requirements of a screening test.
