Clinical trial NCT05275192: Utilization of a Videoscope in Periodontal Regeneration
Official title: Utilization of a Videoscope to Improve Clinical Outcomes of Periodontal Regeneration. A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Periodontitis
Minimally invasive surgery
Videoscope
Guided tissue regeneration
Stage III, Grade B periodontitis
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* • Individual must be between the age of 18 and 70 years of age

  * ASA I or II systemically healthy subjects
  * 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)
  * Radiographic evidence of interproximal alveolar bone loss, on existing (\< 2 years old) dental radiographs of diagnostic quality taken at the COD
  * Vital tooth or previous root canal therapy with no signs/symptoms of pathology
  * Individuals with plaque scores ≤ 20%
  * 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)

Exclusion Criteria:

* Individuals not referred from the Predoctoral Periodontics Student Clinics

  * Uncontrolled systemic disorders such as hypertension, heart disease, bleeding disorders, metabolic bone diseases, autoimmune disorders, etc., that may influence cellular/healing status
  * Diabetics
  * Current smokers
  * Individual less than 18 years of age
  * Individuals with non-isolated, interproximal PD ≥ 4 mm extending to the facial/buccal and/or palatal/lingual tooth surfaces
  * Teeth with Grade 2 or 3 mobility
  * Teeth with metal restorations such as a porcelain fused to metal crown (due to scattering of radiographic images)
  * Intrabony defects on dental implants
  * Individual who take medications known to affect host immunity or periodontal tissues (ex. steroids, antibiotics, phenytoin, etc.) in the previous 6 months
  * Individuals on chronic anti-platelet/anti-coagulant therapy
  * Oral pathologies other than periodontal disease (ex. periapical lesions of non-periodontal origin)
  * Subjects who may be pregnant based on a positive pregnancy test
  * Non-English speaking individuals

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 6 months
measure: Probing Depth (PD)
timeFrame: 6 months
measure: Gingival Recession (GR)
timeFrame: 6 months
measure: Radiographic Bone Height (RBH)
timeFrame: 6 months
measure: Radiographic Bone Volume (RBV)
timeFrame: 6 months
measure: Clinical Attachment Level
timeFrame: 12 months
measure: Probing Depth (PD)
timeFrame: 12 months
measure: Gingival Recession (GR)
timeFrame: 12 months
measure: Radiographic Bone Height (RBH)
timeFrame: 12 months
measure: Radiographic Bone Volume (RBV)
timeFrame: 12 months
Secondary outcomes:
measure: Gingival Crevicular Fluid (GCF) Growth Factor and Cytokine/Chemokine Levels
timeFrame: 6 months
measure: Gingival Crevicular Fluid (GCF) Growth Factor and Cytokine/Chemokine Levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois, Chicago, College of Dentistry, Periodontics
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Salvador Nares, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: