Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05887128

Conditions

Periodontitis

Calculus, Dental

Bone Loss, Alveolar

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05887128

Start date

Jun 1, 2023

Status verified date

Dec, 2023

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Radiographic evidence of calculus [ Time Frame: Baseline - Yes or No ]
  • Radiographic measure of alveolar bone loss [ Time Frame: Baseline - measured in mm ]
  • Clinical evidence of calculus [ Time Frame: Baseline - Yes or No ]
  • Clinical measure of alveolar bone loss [ Time Frame: Baseline - measured in mm ]

Central Contacts and Locations

Central contacts

William Carter, DDS

7065409669william.carter@cuanschutz.edu

Ajay Varghese, DMD

6308641078ajay.varghese@cuanschutz.edu

Locations

Univeristy of Colorado School of Dental Medicine Dental Clinic

Recruiting

Aurora, Colorado, United States, 80045

Contacts

William Carter, DDS

706-540-9669william.carter@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Dec 6, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2023-12-06.