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Utilization of a Videoscope in Periodontal Regeneration

Primary Purpose

Chronic Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Videoscope-assisted periodontal regeneration minimally invasive surgery
Periodontal regeneration minimally invasive surgery
Guided tissue regeneration surgery
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontitis, Minimally invasive surgery, Videoscope, Guided tissue regeneration, Stage III, Grade B periodontitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois, Chicago, College of Dentistry, PeriodonticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Videoscope-assisted periodontal regeneration minimally invasive surgery

Periodontal regeneration minimally invasive surgery

Guided tissue regeneration surgery

Arm Description

Videoscope-assisted periodontal regeneration minimally invasive surgery - Test group

Periodontal regeneration minimally invasive surgery - Control Group 1

Guided tissue regeneration - Control Group 2

Outcomes

Primary Outcome Measures

Clinical Attachment Level
Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).
Probing Depth (PD)
Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus.
Gingival Recession (GR)
Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).
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).
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).
Clinical Attachment Level
Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).
Probing Depth (PD)
Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus.
Gingival Recession (GR)
Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).
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).
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 4, 2022
Last Updated
May 24, 2022
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05275192
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Periodontitis, Minimally invasive surgery, Videoscope, Guided tissue regeneration, Stage III, Grade B periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Videoscope-assisted periodontal regeneration minimally invasive surgery
Arm Type
Experimental
Arm Description
Videoscope-assisted periodontal regeneration minimally invasive surgery - Test group
Arm Title
Periodontal regeneration minimally invasive surgery
Arm Type
Active Comparator
Arm Description
Periodontal regeneration minimally invasive surgery - Control Group 1
Arm Title
Guided tissue regeneration surgery
Arm Type
Active Comparator
Arm Description
Guided tissue regeneration - Control Group 2
Intervention Type
Device
Intervention Name(s)
Videoscope-assisted periodontal regeneration minimally invasive surgery
Intervention Description
Use of a videoscope to improve visualization of periodontal defect during minimally invasive surgery
Intervention Type
Procedure
Intervention Name(s)
Periodontal regeneration minimally invasive surgery
Intervention Description
Conventional periodontal regeneration minimally invasive surgery without use of a videoscope
Intervention Type
Procedure
Intervention Name(s)
Guided tissue regeneration surgery
Intervention Description
Conventional guided tissue regeneration surgery for periodontal regeneration without use of a videoscope
Primary Outcome Measure Information:
Title
Clinical Attachment Level
Description
Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).
Time Frame
6 months
Title
Probing Depth (PD)
Description
Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus.
Time Frame
6 months
Title
Gingival Recession (GR)
Description
Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).
Time Frame
6 months
Title
Radiographic Bone Height (RBH)
Description
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
Title
Radiographic Bone Volume (RBV)
Description
Measured in cubic mm as the volume of bone from the alveolar crest (AC) to the base of the alveolar bone defect (ABD).
Time Frame
6 months
Title
Clinical Attachment Level
Description
Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).
Time Frame
12 months
Title
Probing Depth (PD)
Description
Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus.
Time Frame
12 months
Title
Gingival Recession (GR)
Description
Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).
Time Frame
12 months
Title
Radiographic Bone Height (RBH)
Description
Measured in mm as the distance from the cemento-enamel junction (CEJ) to the base of the alveolar bone defect (ABD).
Time Frame
12 months
Title
Radiographic Bone Volume (RBV)
Description
Measured in cubic mm as the volume of bone from the alveolar crest (AC) to the base of the alveolar bone defect (ABD).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Gingival Crevicular Fluid (GCF) Growth Factor and Cytokine/Chemokine Levels
Description
Concentration of 24 cytokines, chemokines, and growth factors in gingival crevicular fluid (GCF) measured in pg/mL.
Time Frame
6 months
Title
Gingival Crevicular Fluid (GCF) Growth Factor and Cytokine/Chemokine Levels
Description
Concentration of 24 cytokines, chemokines, and growth factors in gingival crevicular fluid (GCF) measured in pg/mL.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salvador Nares, DDS, PhD
Phone
312-413-5787
Email
snares@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvador Nares, DDS, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois, Chicago, College of Dentistry, Periodontics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvador Nares, DDS PhD
Phone
312-413-5787
Email
snares@uic.edu
First Name & Middle Initial & Last Name & Degree
Tolga Tozum, DDS PhD
Phone
312-413-4467
Email
ttozum@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Utilization of a Videoscope in Periodontal Regeneration

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