NCT05275192

Utilization of a Videoscope in Periodontal Regeneration

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Chronic Periodontitis

Interventions

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

Timeline

• Start date: 2022-05-01
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2022-03-11
• Last updated: 2024-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study