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

NCT05887128 | Unknown

• 1 other identifier: 22-2079
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis; Calculus, Dental; Bone Loss, Alveolar

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Univeristy of Colorado School of Dental Medicine Dental Clinic

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Periodontitis; Dental Calculus; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Officials

• William Carter, DDS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Carter, DDS

CONTACT

7065409669; william.carter@cuanschutz.edu

Ajay Varghese, DMD

CONTACT

6308641078; ajay.varghese@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: June 2, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)