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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683016
• Other study ID #: QU001
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2020
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brief Illness Perception Questionnaire (Brief IPQ) before and after non-surgical periodontal treatment	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.
Primary	Change in Oral Health Impact Profile 14 before and after non-surgical periodontal treatment	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	Change in Full Mouth Bleeding Score (FMBS) before and after non-surgical periodontal treatment	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.