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Utilization of a Videoscope in Periodontal Regeneration

NCT ID: NCT05275192

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2026-12-31

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.

Detailed Description

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Conditions

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Chronic Periodontitis

Keywords

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Periodontitis Minimally invasive surgery Videoscope Guided tissue regeneration Stage III, Grade B periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Videoscope-assisted periodontal regeneration minimally invasive surgery

Videoscope-assisted periodontal regeneration minimally invasive surgery - Test group

Group Type EXPERIMENTAL

Videoscope-assisted periodontal regeneration minimally invasive surgery

Intervention Type DEVICE

Use of a videoscope to improve visualization of periodontal defect during minimally invasive surgery

Periodontal regeneration minimally invasive surgery

Periodontal regeneration minimally invasive surgery - Control Group 1

Group Type ACTIVE_COMPARATOR

Periodontal regeneration minimally invasive surgery

Intervention Type PROCEDURE

Conventional periodontal regeneration minimally invasive surgery without use of a videoscope

Guided tissue regeneration surgery

Guided tissue regeneration - Control Group 2

Group Type ACTIVE_COMPARATOR

Guided tissue regeneration surgery

Intervention Type PROCEDURE

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

Interventions

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Videoscope-assisted periodontal regeneration minimally invasive surgery

Use of a videoscope to improve visualization of periodontal defect during minimally invasive surgery

Intervention Type DEVICE

Periodontal regeneration minimally invasive surgery

Conventional periodontal regeneration minimally invasive surgery without use of a videoscope

Intervention Type PROCEDURE

Guided tissue regeneration surgery

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Salvador Nares, DDS, MS, PHD, MBA

Professor and Department Head

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salvador Nares, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois, Chicago, College of Dentistry, Periodontics

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Salvador Nares, DDS, PhD

Role: CONTACT

Phone: 312-413-5787

Email: [email protected]

Facility Contacts

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Salvador Nares, DDS PhD

Role: primary

Tolga Tozum, DDS PhD

Role: backup

Other Identifiers

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2021-1311

Identifier Type: -

Identifier Source: org_study_id