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

Completed

• Conditions: Periodontitis
• Interventions: Other: Questionnaires

• Registration Number: NCT04683016
• Lead Sponsor: University of Siena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01
• Study First Submitted: 2020-10-24
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-19
• Last Update Submitted: 2020-12-19
• Study First Posted: 2020-12-24
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontitis patients	Questionnaires	Patients with a diagnosis of periodontitis, irrespective of its stage and grade.

Primary Outcome Measures

Name	Time	Method
Change in Brief Illness Perception Questionnaire (Brief IPQ) before and after non-surgical periodontal treatment	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	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 Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (1)

AOUS; 🇮🇹 Siena, Italy