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

Periodontitis Clinical Trial

Official title:

Oral Health Related Quality of Life in Patients Affected by Periodontitis Stage III and IV: a Survey Based on OHIP14 Questionnaire

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05481567
• Other study ID #: Perio3
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The purpose of this study is to evaluate the impact of stage III and stage IV periodontitis on the quality of life of patients and to evaluate the differences of the results between the two forms of the disease. Patients who presents to our periodontology department for routine follow-up visits, if diagnosed with one of these two forms of periodontitis, will be asked if they intend to answer a short questionnaire with the intent to understand how the disease affects their daily activities and interactions. The questionnaire that will be used is the short-form Oral Health Impact Profile (OHIP-14), which consists of 14 questions each one formulated in the following way: "How often (impact item) because of problems with your teeth, mouth, or dentures?" The impact items belong to seven different impact domains: (a) functional limitations, (b) physical pain, (c) psychological discomfort, (d) physical disability, (e) psychological disability, (f) social disability, and (g) handicap. Each question could be answered with a score from 0 to 4 corresponding to: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, and 4 = very often. The impact items are: Had trouble in pronouncing words Felt that sense of taste had worsened Had painful aching in your mouth Found it uncomfortable when eating food Been feeling self-conscious Have you felt tense Diet has been unsatisfactory Had to interrupt meals Found it difficult to relax Been a bit embarrassed Been irritable with other people Had difficulty during usual jobs Felt that life less satisfying Been totally unable to function Overall mean scores as well as for each question and for each impact domain will be calculated and compared with two ways ANOVA statistical analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Questionnaire
A series of 14 questions about with the impact of periodontitis on quality of life.

Locations

Country	Name	City	State
Italy	Policlinico Duilio Casula, AOU Cagliari	Monserrato	CA

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact domain 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)