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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05887128
Other study ID # 22-2079
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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