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

NCT ID: NCT05481567

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Periodontitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Stage III

Patients diagnosed with periodontitis stage III

Questionnaire

Intervention Type OTHER

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

Stage IV

Patients diagnosed with periodontitis stage IV

Questionnaire

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Nicola Alberto Valente, DDS, MS, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico Duilio Casula, AOU Cagliari

Monserrato, CA, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 32473794 (View on PubMed)

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.

Reference Type RESULT
PMID: 32594621 (View on PubMed)

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.

Reference Type RESULT
PMID: 30341963 (View on PubMed)

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.

Reference Type RESULT
PMID: 28969266 (View on PubMed)

Other Identifiers

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Perio3

Identifier Type: -

Identifier Source: org_study_id

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