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RecruitingNCT05887128Updated Dec 6, 2023

Accuracy of Extra-oral Bite-wing Radiography in Detecting Calculus and Crestal Bone Loss

An observational study in Periodontitis, Calculus, Dental and Bone Loss, Alveolar, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontitis
  • Calculus, Dental
  • Bone Loss, Alveolar
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Radiographic evidence of calculus

    Radiographic evidence of calculus

    Time frame: Baseline - Yes or No

  2. Radiographic measure of alveolar bone loss

    Radiographic measure (mm) of alveolar bone loss, as measured from the Cemento-enamel-junction to base of defect

    Time frame: Baseline - measured in mm

  3. Clinical evidence of calculus

    Clinical evidence of calculus

    Time frame: Baseline - Yes or No

  4. 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

    Time frame: Baseline - measured in mm

06

Study locations

1 of 1 sites recruiting
  • Univeristy of Colorado School of Dental Medicine Dental Clinic
    Aurora, Colorado 80045, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05887128
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jun 2, 2023
Start date
Jun 1, 2023
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Dec 6, 2023

Study contacts

William Carter, DDS
Contact
william.carter@cuanschutz.edu
7065409669
Ajay Varghese, DMD
Contact
ajay.varghese@cuanschutz.edu
6308641078
William Carter, DDS
principal investigator · University of Colorado, Denver

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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