Utilization of a Videoscope in Periodontal Regeneration

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT05275192
Status
Recruiting

Conditions

  • Chronic Periodontitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Videoscope-assisted periodontal regeneration minimally invasive surgery — DEVICE
    Use of a videoscope to improve visualization of periodontal defect during minimally invasive surgery
  • Periodontal regeneration minimally invasive surgery — PROCEDURE
    Conventional periodontal regeneration minimally invasive surgery without use of a videoscope
  • Guided tissue regeneration surgery — PROCEDURE
    Conventional guided tissue regeneration surgery for periodontal regeneration without use of a videoscope

Study Details

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.

Key Dates

Start date
May 1, 2022
Status verified
Dec 2024
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Videoscope-assisted periodontal regeneration minimally invasive surgery
    Videoscope-assisted periodontal regeneration minimally invasive surgery - Test group
  • Active Comparator: Periodontal regeneration minimally invasive surgery
    Periodontal regeneration minimally invasive surgery - Control Group 1
  • Active Comparator: Guided tissue regeneration surgery
    Guided tissue regeneration - Control Group 2

Primary Outcome Measure

Clinical Attachment Level [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois, Chicago, College of Dentistry, PeriodonticsChicagoIllinois60612
Salvador Nares, DDS PhD
312-413-5787
Tolga Tozum, DDS PhD
312-413-4467

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