RECRUITING

Utilization of a Videoscope in Periodontal Regeneration

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Clinical and preclinical studies confirm that regeneration of supporting tissues of teeth lost due to periodontal disease can be achieved using the principles of minimally invasive surgery (MIS). Although this therapeutic approach is well established in clinical settings and can rescue teeth with poor or questionable prognosis, MIS approaches often suffer from lack of predictability due to poor intraoral visibility of the bony lesion and inability to confirm thorough removal of etiological factors (plaque/calculus) on tooth surfaces. We seek to investigate whether improved visualization of the surgical field using an FDA approved videoscope (V) improves clinical outcomes. For this pilot study, N=50 (to attain 10/group) age, sex matched, systemically healthy subjects diagnosed with Stage III, Grade B periodontitis, formerly known as severe chronic periodontitis, will be randomly assigned to either the VMIS (Test), MIS (Control 1) or Guided Tissue Regeneration (GTR, Control 2) group. All periodontal therapy will be performed following the Standard of Care for periodontal regeneration to determine if utilization of the videoscope improves clinical and radiographic outcomes. We will examine bone fill using conventional digital periapical radiographs (PAR) and Cone Beam Computed Tomography (CBCT) imaging at 6 and 12 months compared to baseline and collect gingival crevicular fluid (GCF) to compare expression of growth factors and cytokines/chemokines during the healing period. This is a single center treatment study where subjects will be recruited from individuals seeking periodontal treatment at the Graduate Periodontics Clinic, UIC College of Dentistry (COD). Participation of all subjects will end after 12 months and will comprise 7 total visits.

Official Title

Utilization of a Videoscope to Improve Clinical Outcomes of Periodontal Regeneration. A Pilot Study

Quick Facts

Study Start:2022-05-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05275192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Individual must be between the age of 18 and 70 years of age
  2. * ASA I or II systemically healthy subjects
  3. * Individuals presenting with at least 1 single or multirooted tooth with residual, isolated, interproximal bony defect with probing depths (PD) ≥ 6 mm, clinical attachment loss (CAL) ≥ 6mm, bleeding upon probing (BOP), and ≥ 2mm width of attached gingiva (WAG)
  4. * Radiographic evidence of interproximal alveolar bone loss, on existing (\< 2 years old) dental radiographs of diagnostic quality taken at the COD
  5. * Vital tooth or previous root canal therapy with no signs/symptoms of pathology
  6. * Individuals with plaque scores ≤ 20%
  7. * English speaking subjects (Individual must be willing to follow all the study requirements and participate in the study procedures in its entirety and read, understand the informed consent form)
  1. * Individuals not referred from the Predoctoral Periodontics Student Clinics
  2. * Uncontrolled systemic disorders such as hypertension, heart disease, bleeding disorders, metabolic bone diseases, autoimmune disorders, etc., that may influence cellular/healing status
  3. * Diabetics
  4. * Current smokers
  5. * Individual less than 18 years of age
  6. * Individuals with non-isolated, interproximal PD ≥ 4 mm extending to the facial/buccal and/or palatal/lingual tooth surfaces
  7. * Teeth with Grade 2 or 3 mobility
  8. * Teeth with metal restorations such as a porcelain fused to metal crown (due to scattering of radiographic images)
  9. * Intrabony defects on dental implants
  10. * Individual who take medications known to affect host immunity or periodontal tissues (ex. steroids, antibiotics, phenytoin, etc.) in the previous 6 months
  11. * Individuals on chronic anti-platelet/anti-coagulant therapy
  12. * Oral pathologies other than periodontal disease (ex. periapical lesions of non-periodontal origin)
  13. * Subjects who may be pregnant based on a positive pregnancy test
  14. * Non-English speaking individuals

Contacts and Locations

Study Contact

Salvador Nares, DDS, PhD
CONTACT
312-413-5787
snares@uic.edu

Principal Investigator

Salvador Nares, DDS, PhD
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago

Study Locations (Sites)

University of Illinois, Chicago, College of Dentistry, Periodontics
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

  • Salvador Nares, DDS, PhD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-05-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Periodontitis
  • Minimally invasive surgery
  • Videoscope
  • Guided tissue regeneration
  • Stage III, Grade B periodontitis

Additional Relevant MeSH Terms

  • Chronic Periodontitis