Utilization of a Videoscope in Periodontal Regeneration

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Device: Videoscope-assisted periodontal regeneration minimally invasive surgery
* Procedure: Periodontal regeneration minimally invasive surgery
* Procedure: Guided tissue regeneration surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Videoscope-assisted periodontal regeneration minimally invasive surgery<br>Videoscope-assisted periodontal regeneration minimally invasive surgery - Test group | Device: Videoscope-assisted periodontal regeneration minimally invasive surgery<br>* Use of a videoscope to improve visualization of periodontal defect during minimally invasive surgery<br>|
| Active Comparator: Periodontal regeneration minimally invasive surgery<br>Periodontal regeneration minimally invasive surgery - Control Group 1 | Procedure: Periodontal regeneration minimally invasive surgery<br>* Conventional periodontal regeneration minimally invasive surgery without use of a videoscope<br>|
| Active Comparator: Guided tissue regeneration surgery<br>Guided tissue regeneration - Control Group 2 | Procedure: Guided tissue regeneration surgery<br>* Conventional guided tissue regeneration surgery for periodontal regeneration without use of a videoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment Level | Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR). | 6 months | 
| Probing Depth (PD) | Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus. | 6 months | 
| Gingival Recession (GR) | Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ). | 6 months | 
| 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). | 6 months | 
| Radiographic Bone Volume (RBV) | Measured in cubic mm as the volume of bone from the alveolar crest (AC) to the base of the alveolar bone defect (ABD). | 6 months | 
| Clinical Attachment Level | Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR). | 12 months | 
| Probing Depth (PD) | Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus. | 12 months | 
| Gingival Recession (GR) | Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ). | 12 months | 
| 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). | 12 months | 
| Radiographic Bone Volume (RBV) | Measured in cubic mm as the volume of bone from the alveolar crest (AC) to the base of the alveolar bone defect (ABD). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Minimally invasive surgery, Videoscope, Guided tissue regeneration, Stage III, Grade B periodontitis