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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887128
• Other study ID #: 22-2079
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: University of Colorado, Denver
• Contact: William Carter, DDS
• Phone: 7065409669
• Email: william.carter[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Univeristy of Colorado School of Dental Medicine Dental Clinic	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic evidence of calculus	Radiographic evidence of calculus	Baseline - Yes or No
Primary	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
Primary	Clinical evidence of calculus	Clinical evidence of calculus	Baseline - Yes or No
Primary	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