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

NCT04683016 | Completed

• 1 other identifier: QU001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Oral Health Impact Profile 14; OHIP 14; non surgical periodontal treatment; brief-Illness Perception Questionnaire

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• 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 Arms (1)

Periodontitis patients

Patients with a diagnosis of periodontitis, irrespective of its stage and grade.

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Periodontitis patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: December 24, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

IT (1)