Periodontitis Stage III and IV and Oral Health Related Quality of Life

NCT05481567 | Unknown DMC

• 1 other identifier: Perio3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with stage III or IV periodontitis during routine visits at the department of periodontology will undergo a validated questionnaire to understand the impact of the disease on their quality of life.

Conditions

Periodontitis

Keywords

Periodontitis; OHIP14; Quality of life; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Overall score

  The sum of the scores of each of the seven impact domains of the Oral Health Impact Profile OHIP14 survey (0 = never to 4 = very often)

  1 day (At the time of evaluation, the first time the patients is evaluated and diagnosed with either periodontitis stage III or stage IV)

Secondary Outcomes (1)

• Impact domain score

  1 day (At the time of evaluation, the first time the patients is evaluated and diagnosed with either periodontitis stage III or stage IV)

Study Arms (2)

Stage III

Patients diagnosed with periodontitis stage III

Other: Questionnaire

Stage IV

Patients diagnosed with periodontitis stage IV

Other: Questionnaire

Interventions

Questionnaire OTHER

A series of 14 questions about with the impact of periodontitis on quality of life.

Stage III; Stage IV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of any age affected by periodontitis stage III or stage IV willing to answer a questionnaire about their quality of life

You may qualify if:

• Patients affected by periodontitis stage III
• Patients affected by periodontitis stage IV

You may not qualify if:

• Patients affected by periodontitis stage I
• Patients affected by periodontitis stage II

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Policlinico Duilio Casula, AOU Cagliari

Monserrato, CA, 09042, Italy

Location

Related Publications (4)

• Palaiologou A, Kotsakis GA. Dentist-Patient Communication of Treatment Outcomes in Periodontal Practice: A Need for Dental Patient-Reported Outcomes. J Evid Based Dent Pract. 2020 Jun;20(2):101443. doi: 10.1016/j.jebdp.2020.101443. Epub 2020 Apr 27.

  PMID: 32473794 BACKGROUND

• Khan S, Khalid T, Bettiol S, Crocombe LA. Non-surgical periodontal therapy effectively improves patient-reported outcomes: A systematic review. Int J Dent Hyg. 2021 Feb;19(1):18-28. doi: 10.1111/idh.12450. Epub 2020 Jul 16.

  PMID: 32594621 RESULT

• Sharma P, Yonel Z, Busby M, Chapple IL, Dietrich T. Association between periodontal health status and patient-reported outcomes in patients managed in a non-specialist, general dental practice. J Clin Periodontol. 2018 Dec;45(12):1440-1447. doi: 10.1111/jcpe.13022. Epub 2018 Nov 5.

  PMID: 30341963 RESULT

• Baiju RM, Peter E, Varghese NO, Anju P. Patient Reported Outcome Assessment of Periodontal Therapy: A Systematic Review. J Clin Diagn Res. 2017 Aug;11(8):ZC14-ZC19. doi: 10.7860/JCDR/2017/28505.10343. Epub 2017 Aug 1.

  PMID: 28969266 RESULT

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: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 1, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be submitted for publication right after the analysis of the outcomes

Locations

IT (1)