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

December 19, 2020 updated by: Nicola Discepoli, University of Siena
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • AOUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with a diagnosis of Periodontitis will be eligible for the inclusion in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periodontitis patients
Patients with a diagnosis of periodontitis, irrespective of its stage and grade.
Other: Questionnaires

Patients will be asked two sets of questions:

  • questionnaire about their perception of periodontal disease (Brief Illness Perception Questionnaire; 9 questions, answers will be registered on a scale of 0 to 10);
  • Oral Health Impact Profile 14 (OHIP-14) questionnaire.

All these two sets of questions will be asked before and after non surgical periodontal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Full Mouth Bleeding Score (FMBS) before and after non-surgical periodontal treatment
Time Frame: 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.
Full Mouth Bleeding Score will be calculated as the percentage of sites with Bleeding on Probing on the total number of sites (percentage ranging between 0% and 100%). Higher scores of FMBS mean more periodontal inflammation and therefore worse oral health (higher scores of FMBS, worse outcomes).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2020

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

October 24, 2020

First Submitted That Met QC Criteria

December 19, 2020

First Posted (ACTUAL)

December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QU001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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