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

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 Overview

• Status: Recruiting
• Conditions: Periodontitis; Bone Loss, Alveolar; Calculus, Dental

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: William Carter, DDS; Phone Number: 7065409669; Email: william.carter@cuanschutz.edu
• Study Contact Backup: Name: Ajay Varghese, DMD; Phone Number: 6308641078; Email: ajay.varghese@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Univeristy of Colorado School of Dental Medicine Dental Clinic
      • Contact: William Carter, DDS; Phone Number: 706-540-9669; Email: william.carter@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evidence of calculus	Radiographic evidence of calculus	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	Baseline - measured in mm
Clinical evidence of calculus	Clinical evidence of calculus	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	Baseline - measured in mm

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: William Carter, DDS, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Bone Diseases; Tooth Diseases; Periodontal Atrophy; Dental Deposits; Bone Resorption; Periodontitis; Calculi; Alveolar Bone Loss; Dental Calculus
• Other Study ID Numbers: 22-2079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No