Utilization of a Videoscope in Periodontal Regeneration

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Illinois at Chicago

About this trial

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

This trial accepts healthy volunteers

Qualifiers

• 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    Conventional periodontal regeneration minimally invasive surgery without use of a videoscope

  • Guided tissue regeneration surgery

    Procedure/Surgery

    Conventional guided tissue regeneration surgery for periodontal regeneration without use of a videoscope

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Videoscope-assisted periodontal regeneration minimally invasive surgeryExperimental treatment 1 intervention
Group B: Periodontal regeneration minimally invasive surgeryActive comparator 1 intervention
Group C: Guided tissue regeneration surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Attachment Level

Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).

Time frame
6 months
2

Probing Depth (PD)

Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus.

Time frame
6 months
3

Gingival Recession (GR)

Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).

Time frame
6 months
4

Radiographic Bone Height (RBH)

Measured in mm as the distance from the cemento-enamel junction (CEJ) to the base of the alveolar bone defect (ABD).

Time frame
6 months

Secondary outcomes

1

Gingival Crevicular Fluid (GCF) Growth Factor and Cytokine/Chemokine Levels

Concentration of 24 cytokines, chemokines, and growth factors in gingival crevicular fluid (GCF) measured in pg/mL.

Time frame
6 months
2

Gingival Crevicular Fluid (GCF) Growth Factor and Cytokine/Chemokine Levels

Concentration of 24 cytokines, chemokines, and growth factors in gingival crevicular fluid (GCF) measured in pg/mL.

Time frame
12 months

Other outcomes

Sponsors and contacts

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