PeriodontitisNCT05481567
Periodontitis Stage III and IV and Oral Health Related Quality of Life
An observational study of Periodontitis, run by University of Cagliari at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis
- What is being tested?
- Questionnaire
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of any age affected by periodontitis stage III or stage IV willing to answer a questionnaire about their quality of life
Who may be able to join
- Patients affected by periodontitis stage III
- Patients affected by periodontitis stage IV
Who cannot join
- Patients affected by periodontitis stage I
- Patients affected by periodontitis stage II
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Related Quality of Life in Patients Affected by Periodontitis Stage III and IV: a Survey Based on OHIP14 Questionnaire
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.
Read the detailed 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.
- Conditions
- Periodontitis
- Being tested
- Questionnaire
- Keywords
- Periodontitis, OHIP14, Quality of life, Questionnaire
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A series of 14 questions about with the impact of periodontitis on quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Stage III | Patients diagnosed with periodontitis stage III Receives: Other: Questionnaire | |
| Stage IV | Patients diagnosed with periodontitis stage IV Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 1 day (At the time of evaluation, the first time the patients is evaluated and diagnosed with either periodontitis stage III or stage IV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Alberto Valente, DDS, MS, PhD, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481567
- Sponsor's protocol ID
- Perio3
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared in a publication after the end of the study
Publications
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.
PubMed 32473794Khan 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.
PubMed 32594621Sharma 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.
PubMed 30341963Baiju 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.
PubMed 28969266
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Related Quality of Life in Patients Affected by Periodontitis Stage III and IV: a Survey Based on OHIP14 Questionnaire
- ClinicalTrials.gov ID
- NCT05481567
- Acronym / sponsor ID
- Perio3
- Conditions
- Periodontitis
- Keywords
- Periodontitis, OHIP14, Quality of life, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage III | – | Other: QuestionnairePatients diagnosed with periodontitis stage III |
| Stage IV | – | Other: QuestionnairePatients diagnosed with periodontitis stage IV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of any age affected by periodontitis stage III or stage IV willing to answer a questionnaire about their quality of life
Key inclusion criteria (2 listed)
- Patients affected by periodontitis stage III
- Patients affected by periodontitis stage IV
Key exclusion criteria (2 listed)
- Patients affected by periodontitis stage I
- Patients affected by periodontitis stage II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA series of 14 questions about with the impact of periodontitis on quality of life. | Other | Stage III, Stage IV |
Primary outcome
Overall score
Time frame: 1 day (At the time of evaluation, the first time the patients is evaluated and diagnosed with either periodontitis stage III or stage IV)
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 secondary outcome
Impact domain score
Time frame: 1 day (At the time of evaluation, the first time the patients is evaluated and diagnosed with either periodontitis stage III or stage IV)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 32473794Palaiologou 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.
- Results publication: PubMed 32594621Khan 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.
- Results publication: PubMed 30341963Sharma 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.
- Results publication: PubMed 28969266Baiju 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared in a publication after the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall score (time frame: 1 day (At the time of evaluation, the first time the patients is evaluated and diagnosed with either periodontitis stage III or stage IV)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05481567, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.