PeriodontitisNCT05202132
Masticatory Function in the Differential Diagnosis of Stage IV Periodontitis
An observational study of Periodontitis, run by The European Research Group on Periodontology (ERGOPerio) at 2 sites in 2 countries.
Trial summary
This is a pilot diagnostic accuracy study to assess the ability to discriminate in a screening context Stage IV periodontitis from other stages of periodontitis. The index test is the assessment of masticatory dysfunction performed with a questionnaire and a chewing gum test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Questionnaire and Chewing gum test
- How many people
- 214 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2020to 30 Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Convenience, quota sample (equal number of subjects with stage I, II, III and IV periodontitis) of consecutive patients referred for dental care to the reception clinic of the Prince Philip Dental Hospital
Who may be able to join
- Periodontitis subjects reporting for care at reception clinic of dental hospital
Who cannot join
- presence of temporomandibular disorders,
- subjects undergoing orthodontic treatment
- less than 12 teeth;
- subjects having received periodontal treatment in the previous 12 months;
- subjects having received antibiotic medication in the previous 3 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
Prince Philip Dental Hospital, the Univerisity of Hong Kong
Hong Kong
About this study
Official title: Pilot Study on the Accuracy of Masticatory Function Assessment to Discriminate Stage IV Periodontitis From Other Periodontitis Cases
This is a pilot diagnostic accuracy study to assess the ability to discriminate in a screening context Stage IV periodontitis from other stages of periodontitis. The index test is the assessment of masticatory dysfunction performed with a questionnaire and a chewing gum test. The reference standard is a full periodontal and functional assessment performed by a trained and calibrated specialist.
Read the detailed description
This is a pilot diagnostic accuracy study. Data are derived from a cross-sectional study based on a convenience, quota sample of patients referred for dental care to the reception clinic of the Prince Philip Dental Hospital or at the Institute of Advanced Dentistry, the University of Hong Kong between October 2020 and May 2021. The study will be conducted in accordance with the current revision of the Declaration of Helsinki. Informed consent will be obtained from all participants prior to enrollment in the study. This study will follow the Standards for Reporting Diagnostic Accuracy (STARD) guidelines. To limit bias, separate calibrated examiners performed the index test (chewing gum test) and the periodontal examination used for periodontitis stage and grade diagnosis (reference standard).
To evaluate the diagnostic accuracy of masticatory function assessment for Stage IV periodontitis, logistic regression analyses will be conducted in univariate analyses and the area under the receiver operating characteristic curve (AUROC), diagnostic odds ratios (DORs), sensitivity, specificity, positive predictive values and negative predictive values will be calculated.
Multivariate logistic regression models will be applied to develop a screening algorithm for Stage IV periodontitis diagnosis including the masticatory function assessment and other candidate predictors. A backward stepwise selection method will be used (p = 0.05 for inclusion in model; p = 0.05 for removal from model). The standard nomenclature for interpreting low, moderate and high levels of accuracy will be based on sensitivity and specificity as well as the AUROC values: low level = sensitivity or specificity <60%, AUROC ≤ 0.70; moderate level = sensitivity or specificity ranging from 60% to 79%, AUROC ranging from 0.71 to 0.90; high level = sensitivity or specificity ≥ 80%, AUROC>0.90
- Conditions
- Periodontitis
- Being tested
- Questionnaire, Chewing gum test
- Keywords
- periodontitis, Screening, diagnostic accuracy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireDiagnostic test
A 3 item validated questionnaire assessing masticatory function
Chewing gum testDiagnostic test
The test is based on the ability of a subject of mixing a two colour chewing gum with 20 masticatory cycles. Mixing of the two colour chewing gum will be assessed as variance of hue in a scanned image of the flattened chewing gum. The method has been validated in independent studies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Area under the receiver operating curve (AUROC)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Oct 2020
- Primary completion31 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)
- Sponsor type
- Research network
- Collaborators
- The University of Hong Kong, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Sponsor
- Investigators
- Maurizio Tonetti, DMD, Principal investigator, The European Research Group on Periodontology (ERGOPerio)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202132
- Sponsor's protocol ID
- UW20-637
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Accuracy of Masticatory Function Assessment to Discriminate Stage IV Periodontitis From Other Periodontitis Cases
- ClinicalTrials.gov ID
- NCT05202132
- Acronym / sponsor ID
- UW20-637
- Conditions
- Periodontitis
- Keywords
- periodontitis, Screening, diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)Research network
- Collaborators
- The University of Hong Kong, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Jan 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.
This is a pilot diagnostic accuracy study to assess the ability to discriminate in a screening context Stage IV periodontitis from other stages of periodontitis. The index test is the assessment of masticatory dysfunction performed with a questionnaire and a chewing gum test. The reference standard is a full periodontal and functional assessment performed by a trained and calibrated specialist.
Detailed description
This is a pilot diagnostic accuracy study. Data are derived from a cross-sectional study based on a convenience, quota sample of patients referred for dental care to the reception clinic of the Prince Philip Dental Hospital or at the Institute of Advanced Dentistry, the University of Hong Kong between October 2020 and May 2021. The study will be conducted in accordance with the current revision of the Declaration of Helsinki. Informed consent will be obtained from all participants prior to enrollment in the study. This study will follow the Standards for Reporting Diagnostic Accuracy (STARD) guidelines. To limit bias, separate calibrated examiners performed the index test (chewing gum test) and the periodontal examination used for periodontitis stage and grade diagnosis (reference standard).
To evaluate the diagnostic accuracy of masticatory function assessment for Stage IV periodontitis, logistic regression analyses will be conducted in univariate analyses and the area under the receiver operating characteristic curve (AUROC), diagnostic odds ratios (DORs), sensitivity, specificity, positive predictive values and negative predictive values will be calculated.
Multivariate logistic regression models will be applied to develop a screening algorithm for Stage IV periodontitis diagnosis including the masticatory function assessment and other candidate predictors. A backward stepwise selection method will be used (p = 0.05 for inclusion in model; p = 0.05 for removal from model). The standard nomenclature for interpreting low, moderate and high levels of accuracy will be based on sensitivity and specificity as well as the AUROC values: low level = sensitivity or specificity <60%, AUROC ≤ 0.70; moderate level = sensitivity or specificity ranging from 60% to 79%, AUROC ranging from 0.71 to 0.90; high level = sensitivity or specificity ≥ 80%, AUROC>0.90
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience, quota sample (equal number of subjects with stage I, II, III and IV periodontitis) of consecutive patients referred for dental care to the reception clinic of the Prince Philip Dental Hospital
Key inclusion criteria (1 listed)
- Periodontitis subjects reporting for care at reception clinic of dental hospital
Key exclusion criteria (5 listed)
- presence of temporomandibular disorders,
- subjects undergoing orthodontic treatment
- less than 12 teeth;
- subjects having received periodontal treatment in the previous 12 months;
- subjects having received antibiotic medication in the previous 3 months
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 3 item validated questionnaire assessing masticatory function | Diagnostic test | – |
| Chewing gum testThe test is based on the ability of a subject of mixing a two colour chewing gum with 20 masticatory cycles. Mixing of the two colour chewing gum will be assessed as variance of hue in a scanned image of the flattened chewing gum. The method has been validated in independent studies. | Diagnostic test | – |
Primary outcome
Diagnostic accuracy
Time frame: Baseline
Area under the receiver operating curve (AUROC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Maurizio Tonetti, DMD principal investigator
The European Research Group on Periodontology (ERGOPerio)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by The European Research Group on Periodontology (ERGOPerio) at 2 sites in 2 countries.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2022.