PeriodontitisNCT05887128
Accuracy of Extra-oral Bite-wing Radiography in Detecting Calculus and Crestal Bone Loss
An observational study of Periodontitis and Calculus, Dental, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To compare the diagnostic accuracy of extra-oral x-rays with intra-oral x-rays, in contrast to clinically observed measurements, for the detection of calculus and bone loss of either the suprabony or infrabony types in patients undergoing periodontal surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Periodontitis, Calculus, Dental, Bone Loss, Alveolar
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Jun 2025
- How long will I take part?
- 1 Year
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 40 individuals who are currently active patients at the University of Colorado School of Dental Medicine Graduate Periodontics Department. Intra-oral x-rays will be taken on examination, which is the standard of care. Patients who require periodontal surgery and have signed treatment plans to undergo the surgery will be asked to participate in the study. Extra-oral x-rays will be taken at that time, which is for research purpose. This is the same exposure as a panoramic x-ray, which is the standard of care to receive along with the intra-oral x-rays. Patients will be excluded if they have a recent panoramic x-ray.
Who may be able to join
- Patients must be active patients of record at CU School of Dental Medicine
- Patients will have an active treatment plan for periodontal open flap surgery
- Patients will be classified as either ASA I or ASA II
- Patients must have periodontal probing depths >/= 5mm and radiographic sings of marginal bone loss (supra or infra bony)
Who cannot join
- Less than 18 years of age
- ASA III or above
- Emergency patients
- Pregnant patients
- Patients who are not patients of record at the CU School of Dental Medicine
- Patients with a recent panoramic radiograph that contraindicates the need for new imaging in the form of extra-oral bitewings
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Univeristy of Colorado School of Dental Medicine Dental Clinic
Aurora, Colorado, 80045
William Carter, DDS, 706-540-9669, william.carter@cuanschutz.edu
About this study
To compare the diagnostic accuracy of extra-oral x-rays with intra-oral x-rays, in contrast to clinically observed measurements, for the detection of calculus and bone loss of either the suprabony or infrabony types in patients undergoing periodontal surgery.
- Conditions
- Periodontitis, Calculus, Dental, Bone Loss, Alveolar
- Medical subject headings
- Periodontitis, Dental Calculus, Alveolar Bone Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evidence of calculus
Radiographic evidence of calculus
Measured: Baseline - Yes or No
Radiographic measure of alveolar bone loss
Radiographic measure (mm) of alveolar bone loss, as measured from the Cemento-enamel-junction to base of defect
Measured: Baseline - measured in mm
Clinical evidence of calculus
Clinical evidence of calculus
Measured: Baseline - Yes or No
Clinical measure of alveolar bone loss
Clinical measure (mm) of alveolar bone loss, as measured from Cemento-enamel-junction to base of defect using a periodontal probe
Measured: Baseline - measured in mm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Carter, DDS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887128
- Sponsor's protocol ID
- 22-2079
- Status last verified
- Dec 2023
- First submitted
- 21 Feb 2023
- Last updated
- 6 Dec 2023
- Results posted
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Extra-oral Bite-wing Radiography in Detecting Calculus and Crestal Bone Loss
- ClinicalTrials.gov ID
- NCT05887128
- Acronym / sponsor ID
- 22-2079
- Conditions
- Periodontitis, Calculus, Dental, Bone Loss, Alveolar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 2 Jun 2023 (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.
To compare the diagnostic accuracy of extra-oral x-rays with intra-oral x-rays, in contrast to clinically observed measurements, for the detection of calculus and bone loss of either the suprabony or infrabony types in patients undergoing periodontal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 40 individuals who are currently active patients at the University of Colorado School of Dental Medicine Graduate Periodontics Department. Intra-oral x-rays will be taken on examination, which is the standard of care. Patients who require periodontal surgery and have signed treatment plans to undergo the surgery will be asked to participate in the study. Extra-oral x-rays will be taken at that time, which is for research purpose. This is the same exposure as a panoramic x-ray, which is the standard of care to receive along with the intra-oral x-rays. Patients will be excluded if they have a recent panoramic x-ray.
Key inclusion criteria (4 listed)
- Patients must be active patients of record at CU School of Dental Medicine
- Patients will have an active treatment plan for periodontal open flap surgery
- Patients will be classified as either ASA I or ASA II
- Patients must have periodontal probing depths >/= 5mm and radiographic sings of marginal bone loss (supra or infra bony)
Key exclusion criteria (6 listed)
- Less than 18 years of age
- ASA III or above
- Emergency patients
- Pregnant patients
- Patients who are not patients of record at the CU School of Dental Medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic evidence of calculus
Time frame: Baseline - Yes or No
Radiographic evidence of calculus
Radiographic measure of alveolar bone loss
Time frame: Baseline - measured in mm
Radiographic measure (mm) of alveolar bone loss, as measured from the Cemento-enamel-junction to base of defect
Clinical evidence of calculus
Time frame: Baseline - Yes or No
Clinical evidence of calculus
Clinical measure of alveolar bone loss
Time frame: Baseline - measured in mm
Clinical measure (mm) of alveolar bone loss, as measured from Cemento-enamel-junction to base of defect using a periodontal probe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 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.
William Carter, DDS principal investigator
University of Colorado, Denver
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 and Calculus, Dental, run by University of Colorado, Denver 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 4 inclusion and 6 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 6 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Carter, DDS (7065409669, william.carter@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic evidence of calculus (time frame: Baseline - Yes or No). The study lists 4 primary outcomes in all. 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 6 Dec 2023.