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Utilization of a Videoscope in Periodontal Regeneration

NCT05275192 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2026-04-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05275192 on ClinicalTrials.gov