Evaluation of a New Self-reported Tool for Periodontitis Screening

NCT02754401 | Completed DMC

• 1 other identifier: 337-13-18112013
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periodontitis and Treatment Need

Keywords

public health; periodontitis; self-reported questionnaire

Outcome Measures

Primary Outcomes (1)

• Evaluation of self reported questionnaire.

  Patients had to fill in a questionnaire of 16 items. Possible answers were yes or no and some different determined answers to offer.

  Baseline (first examination)

Secondary Outcomes (1)

• PSI (periodontal screening index)

  Baseline (first examination)

Study Arms (2)

group 1

OTHER

non-periodontitis persons (PSI 0-2)

Other: 16 Items; Other: PSI

group 2

OTHER

periodontitis persons (PSI 3-4)

Other: 16 Items; Other: PSI

Interventions

16 Items OTHER

Patients took part in the questionnaire and were examined using the PSI (periodontal screening index).

Also known as: self-reported questionnaire

group 1; group 2

PSI OTHER

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. Only the highest finding was noted 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).

Also known as: periodontal screening index

group 1; group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were all unknown to the examiners
• Patients were also required to be at least 18 years
• All study participants were informed of its content and the use of personal data and confirmed their voluntary willingness to take part in writing.

You may not qualify if:

• Patients undergoing a periodontal treatment, antibiotic therapy, pregnant and disabled persons were also excluded from the study.

Sponsors & Collaborators

• Renatus, Antonio Renatus, Dent., M.Sc: lead

Related Publications (1)

• Vierron E, Giraudeau B. Sample size calculation for multicenter randomized trial: taking the center effect into account. Contemp Clin Trials. 2007 Jul;28(4):451-8. doi: 10.1016/j.cct.2006.11.003. Epub 2006 Nov 17.

  PMID: 17188941 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 28, 2016
• Study Start: January 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share