Thyroid DiseasesNCT03369405
Thyroid Disease and Chronic Periodontitis
An observational study of Thyroid Diseases and Chronic Periodontitis, run by University at Buffalo at 1 site in United States.
Trial summary
Currently, the investigators are unaware of any previous studies that have analyzed the relationship between the prevalence of thyroid disease and chronic periodontitis among adults utilizing a retrospective, cross-sectional design. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Diseases, Chronic Periodontitis
- How many people
- 4,965 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2018to 1 Sep 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is sampled from the patient records available at the School of Dental Medicine, University at Buffalo, State University of New York. The patient records reviewed will be of patients seen in the predoctoral as well as postgraduate clinics. The third group population is sampled from the patient records available from the faculty practice of one provider located at the University of Buffalo, State University of New York
Who may be able to join
- Active patient of the School of Dental Medicine, University at Buffalo.
- The remaining eligibility criteria varies between the three distinct subject populations, which are noted below. All eligibility criteria is selected for by an electronic search of patient records performed by the IT Department at the School of Dental Medicine, University at Buffalo.
- Periodontally healthy patients:
- A treatment code of D1110 or D111 was processed at least once but excluding patients that were ever assigned a treatment code of U4990
- A 3rd or 4th year pre-doctoral dental student provider
- 35 years or older as of 1/1/2016
Show all 16Show fewer
- Patient presented to clinic between 1/1/2016-12/31/2016
- Patients with history of advanced periodontal treatment, group 1:
- All patients presenting to the Postgraduate Periodontics Department at UB and being seen by a periodontics resident
- Time period between 1/1/2000-12/31/2017
- Patients will be 35 years or older at time of initial exam
- Patients presenting for reasons other than chronic periodontitis treatment (e.g. crown lengthening) will be labeled as such.
- Patients with history of advanced periodontal treatment, group 2:
- All patients treated in the faculty practice of one periodontist that remained active patients during the time period 1/1/2016-12/31-2016
- All patients were 35 years or older at time of initial exam
- Duplicates within groups are eliminated.
Who cannot join
- inadequate data from records
- Note: the majority of patient records selected by the search criteria done electronically by the IT department will be included in the study, since the search criteria very closely overlaps the overall study criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dental Medicine, University at Buffalo
Buffalo, New York, 14214
About this study
Official title: Thyroid Insufficiency as a Modifying Factor for Chronic Periodontitis
Currently, the investigators are unaware of any previous studies that have analyzed the relationship between the prevalence of thyroid disease and chronic periodontitis among adults utilizing a retrospective, cross-sectional design. This study will review approximately 2000 patient records and compare the prevalence of thyroid disease in three groups with increasing severity of chronic periodontitis.
Read the detailed description
This is a retrospective, cross-sectional patient records review study. Only records with subjects that were 35 years or older and have been active patients of the School of Dental Medicine, University at Buffalo will be included. Three individual searches with three distinct patient criteria will be conducted to obtain records from subjects in three populations with different degrees of periodontal disease. All subjects that qualify the eligibility criteria will be selected. The IT Department has access to select the subjects according to the eligibility criteria without requiring access to the physical patient record. The three subject groups are:
- Periodontally healthy patients: Patients with a D1110 or D1111 (adult prophylaxis including those with 6 or fewer teeth) treatment code, seen by a 3rd or 4th year pre-doctoral dental student. Excludes all charts that have ever had a U4990 (Perio case) treatment code. Patient is 35 years or older relative to 1/1/2016.
- Patients with a history of advanced periodontal treatment, group 1: All patients treated in the Postgraduate Periodontics department by a periodontics resident between 1/1/2000 - 12/31/2017. Patients presenting for treatment of chronic periodontitis will be included while those patients presenting to the clinic for other reasons, such as crown lengthening procedures, will be labeled as such. All patients selected will be 35 years or older at time of initial exam.
- Patients with history of advanced periodontal treatment, group 2: All patients ever treated in the private faculty practice of one periodontist, that were still active patients during between 1/1/16 - 12/31/16. Only those 35 years and older were included. Patients presenting for treatment of chronic periodontitis will be included while those patients presenting to the clinic for other reasons, such as crown lengthening procedures, will be labeled as such.
All duplicates within a group will be excluded (e.g. patients may have had a D1110 code more than once per year). These 3 subject search criteria should yield a sufficient number of patient records for statistical analysis.
All patient records will be reviewed and data will be collected and recorded in an electronic Microsoft Excel database file that is saved on an encrypted flash drive. The only patient identifier recorded will be the patient records number. Once data collection is complete, or at a maximum of 3 years from the start of the study, all identifying information will be deleted and only de-identified data saved on a separate electronic file will be analyzed. No code key will be required.
Data will be analyzed using ANOVA (F-test). If multiple variables are used, analysis will be by using generalized estimating equations (GEE).
- Conditions
- Thyroid Diseases, Chronic Periodontitis
- Being tested
- NO intervention, patient records review only
- Keywords
- periodontitis, hypothyroidism
- Medical subject headings
- Thyroid Diseases, Chronic Periodontitis, Periodontitis, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO intervention, patient records review onlyOther
There is no intervention - the three study groups are created by utilizing three unique sets of search criteria for the patient records review.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally healthy patients | Patients that have no history of periodontal treatment and that have been scheduled for routine prophylaxis appointments in the predoctoral clinics at the School of Dental Medicine, University at Buffalo. Receives: Other: NO intervention, patient records review only | |
| Periodontitis, group 1 | Patients that have been referred from the pre-doctoral dental clinics to the Postgraduate Periodontics clinic for advanced periodontal disease. Clinical attachment loss, pain, mobility, bleeding, suppuration, and probing depths > 4 mm more likely to be prevalent. Receives: Other: NO intervention, patient records review only | |
| Periodontitis, group 2 | Patients referred to a faculty practice periodontist over the course of his clinical career due to chronic periodontitis that could not be treated by the referring general dentist. Clinical attachment loss, pain, mobility, bleeding, suppuration, and probing depths > 4 mm more likely to be prevalent. Receives: Other: NO intervention, patient records review only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid disease prevalence
The presence or absence of thyroid medication in the patient record will be used as a surrogate marker for thyroid disease presence or absence.
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Secondary outcomes (9)
smoking history
Smoking history will be determined from the Medical Questionnaire form in the patient records.
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
diabetes disease prevalence
The Medical Questionnaire and the Medication List in the patient records will be referenced to determine the presence of diabetes.
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Periodontal Probing Depths 5mm or greater
Number of teeth that have one or more sites that contain a 5mm or greater pocket, recorded in periodontal chart
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Periodontal Probing Depths 6mm or greater
Number of teeth that have one or more sites that contain a 6mm or greater pocket, recorded in periodontal chart
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Teeth
Total number of teeth, recorded in periodontal chart
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
proton pump inhibitor use
The Medication List in the patient records will be referenced to determine any history of proton pump inhibitor use.
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Plaque Score
Percentage of tooth surfaces positive for plaque out of total tooth surfaces
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Hormone replacement therapy
The presence or absence of hormone supplementation (birth control or hormone replacement therapy included)
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
bisphosphonate use
The Medication List in the patient records will be referenced to determine any history of bisphosphonate use.
Measured: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start2 Feb 2018
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,965 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lisa Yerke, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369405
- Sponsor's protocol ID
- STUDY00001811
- Status last verified
- Sep 2023
- First submitted
- 28 Nov 2017
- Last updated
- 2 Oct 2023
- 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Insufficiency as a Modifying Factor for Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03369405
- Acronym / sponsor ID
- STUDY00001811
- Conditions
- Thyroid Diseases, Chronic Periodontitis
- Keywords
- periodontitis, hypothyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,965 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 12 Dec 2017 (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.
Currently, the investigators are unaware of any previous studies that have analyzed the relationship between the prevalence of thyroid disease and chronic periodontitis among adults utilizing a retrospective, cross-sectional design. This study will review approximately 2000 patient records and compare the prevalence of thyroid disease in three groups with increasing severity of chronic periodontitis.
Detailed description
This is a retrospective, cross-sectional patient records review study. Only records with subjects that were 35 years or older and have been active patients of the School of Dental Medicine, University at Buffalo will be included. Three individual searches with three distinct patient criteria will be conducted to obtain records from subjects in three populations with different degrees of periodontal disease. All subjects that qualify the eligibility criteria will be selected. The IT Department has access to select the subjects according to the eligibility criteria without requiring access to the physical patient record. The three subject groups are:
- Periodontally healthy patients: Patients with a D1110 or D1111 (adult prophylaxis including those with 6 or fewer teeth) treatment code, seen by a 3rd or 4th year pre-doctoral dental student. Excludes all charts that have ever had a U4990 (Perio case) treatment code. Patient is 35 years or older relative to 1/1/2016.
- Patients with a history of advanced periodontal treatment, group 1: All patients treated in the Postgraduate Periodontics department by a periodontics resident between 1/1/2000 - 12/31/2017. Patients presenting for treatment of chronic periodontitis will be included while those patients presenting to the clinic for other reasons, such as crown lengthening procedures, will be labeled as such. All patients selected will be 35 years or older at time of initial exam.
- Patients with history of advanced periodontal treatment, group 2: All patients ever treated in the private faculty practice of one periodontist, that were still active patients during between 1/1/16 - 12/31/16. Only those 35 years and older were included. Patients presenting for treatment of chronic periodontitis will be included while those patients presenting to the clinic for other reasons, such as crown lengthening procedures, will be labeled as such.
All duplicates within a group will be excluded (e.g. patients may have had a D1110 code more than once per year). These 3 subject search criteria should yield a sufficient number of patient records for statistical analysis.
All patient records will be reviewed and data will be collected and recorded in an electronic Microsoft Excel database file that is saved on an encrypted flash drive. The only patient identifier recorded will be the patient records number. Once data collection is complete, or at a maximum of 3 years from the start of the study, all identifying information will be deleted and only de-identified data saved on a separate electronic file will be analyzed. No code key will be required.
Data will be analyzed using ANOVA (F-test). If multiple variables are used, analysis will be by using generalized estimating equations (GEE).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally healthy patients | – | Other: NO intervention, patient records review onlyPatients that have no history of periodontal treatment and that have been scheduled for routine prophylaxis appointments in the predoctoral clinics at the School of Dental Medicine, University at Buffalo. |
| Periodontitis, group 1 | – | Other: NO intervention, patient records review onlyPatients that have been referred from the pre-doctoral dental clinics to the Postgraduate Periodontics clinic for advanced periodontal disease. Clinical attachment loss, pain, mobility, bleeding, suppuration, and probing depths > 4 mm more likely to be prevalent. |
| Periodontitis, group 2 | – | Other: NO intervention, patient records review onlyPatients referred to a faculty practice periodontist over the course of his clinical career due to chronic periodontitis that could not be treated by the referring general dentist. Clinical attachment loss, pain, mobility, bleeding, suppuration, and probing depths > 4 mm more likely to be prevalent. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is sampled from the patient records available at the School of Dental Medicine, University at Buffalo, State University of New York. The patient records reviewed will be of patients seen in the predoctoral as well as postgraduate clinics. The third group population is sampled from the patient records available from the faculty practice of one provider located at the University of Buffalo, State University of New York
Key inclusion criteria (16 listed)
- Active patient of the School of Dental Medicine, University at Buffalo.
- The remaining eligibility criteria varies between the three distinct subject populations, which are noted below. All eligibility criteria is selected for by an electronic search of patient records performed by the IT Department at the School of Dental Medicine, University at Buffalo.
- Duplicates within groups are eliminated.
Key exclusion criteria (2 listed)
- inadequate data from records
- Note: the majority of patient records selected by the search criteria done electronically by the IT department will be included in the study, since the search criteria very closely overlaps the overall study criteria
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 |
|---|---|---|
| NO intervention, patient records review onlyThere is no intervention - the three study groups are created by utilizing three unique sets of search criteria for the patient records review. | Other | Periodontally healthy patients, Periodontitis, group 1, Periodontitis, group 2 |
Primary outcome
Thyroid disease prevalence
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
The presence or absence of thyroid medication in the patient record will be used as a surrogate marker for thyroid disease presence or absence.
9 secondary outcomes
smoking history
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
diabetes disease prevalence
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Periodontal Probing Depths 5mm or greater
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Periodontal Probing Depths 6mm or greater
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Teeth
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
proton pump inhibitor use
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Plaque Score
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
Hormone replacement therapy
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
bisphosphonate use
Time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).
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 2 Oct 2023.
- 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.
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 Thyroid Diseases and Chronic Periodontitis, run by University at Buffalo at 1 site in United States.
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 16 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: finished, as of the sponsor's last update on 2 Oct 2023. 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 United States. 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?
Thyroid disease prevalence (time frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study).). 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 2 Oct 2023.