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Clinical Trials/NCT04683016
NCT04683016
Completed
Not Applicable

Disease Perception and Oral Health Impact Profile (OHIP) Before and After Non-surgical Periodontal Treatment

University of Siena1 site in 1 country120 target enrollmentJune 1, 2020
ConditionsPeriodontitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
University of Siena
Enrollment
120
Locations
1
Primary Endpoint
Change in Brief Illness Perception Questionnaire (Brief IPQ) before and after non-surgical periodontal treatment
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The presence of periodontal diseases in patients has been associated to a worsened quality of life overall. Many different indices have been proposed over time in order to evaluate patient's centred outcomes. In particular, the most thorough questionnaire proposed so far is the Oral Health Impact Profile 49 (OHIP-49), which is composed of 49 questions. Despite its validity being unquestionable, OHIP-49 was found to be too time-consuming for the clinical scenario and, therefore, its shortened 14-question version has been proposed. A more in-depth knowledge of how these parameters change before and after periodontal treatment could enable clinicians to tailor the treatment plan according to the patients' needs.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
September 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicola Discepoli

Professor

University of Siena

Eligibility Criteria

Inclusion Criteria

  • patients being at least 18 years old
  • Patients with a diagnosis of Periodontitis

Exclusion Criteria

  • diagnosis Gingivitis
  • diagnosis of periodontal health
  • inability or unwillingness to give informed consent

Outcomes

Primary Outcomes

Change in Brief Illness Perception Questionnaire (Brief IPQ) before and after non-surgical periodontal treatment

Time Frame: The questionnaire will be carried out at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the Brief IPQ values at baseline and after 3 months will be considered as the primary outcome measure.

Brief Illness Perception Questionnaire consists of 9 questions, each one evaluated on a scale of 0 to 10 (minimum score of 0, maximum score of 90). Higher scores mean a higher patient's perception of the disease (higher scores mean worse outcome).

Change in Oral Health Impact Profile 14 before and after non-surgical periodontal treatment

Time Frame: The questionnaire will be carried out at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the OHIP-14 values at baseline and after 3 months will be considered as the primary outcome measure.

14 questions about the impact of oral health on the quality of life; each question will be evaluated on a scale of 1 to 5 (minimum score of 0, maximum score of 70). Higher scores mean that patient's oral health impacts more significantly on their quality of life (higher scores, worse outcomes).

Secondary Outcomes

  • Change in Full Mouth Bleeding Score (FMBS) before and after non-surgical periodontal treatment(FMBS will be calculated at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the FMBS at baseline and after 3 months will be considered as the secondary outcome measure.)

Study Sites (1)

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