NCT05275192

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
May 2022Dec 2026

First Submitted

Initial submission to the registry

February 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

February 4, 2022

Last Update Submit

December 9, 2024

Conditions

Chronic Periodontitis

Keywords

PeriodontitisMinimally invasive surgeryVideoscopeGuided tissue regenerationStage III, Grade B periodontitis

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (2)

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

    6 months

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

    12 months

Study Arms (3)

Videoscope-assisted periodontal regeneration minimally invasive surgery

EXPERIMENTAL

Videoscope-assisted periodontal regeneration minimally invasive surgery - Test group

Device: Videoscope-assisted periodontal regeneration minimally invasive surgery

Periodontal regeneration minimally invasive surgery

ACTIVE COMPARATOR

Periodontal regeneration minimally invasive surgery - Control Group 1

Procedure: Periodontal regeneration minimally invasive surgery

Guided tissue regeneration surgery

ACTIVE COMPARATOR

Guided tissue regeneration - Control Group 2

Procedure: Guided tissue regeneration surgery

Interventions

Videoscope-assisted periodontal regeneration minimally invasive surgeryDEVICE

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

Videoscope-assisted periodontal regeneration minimally invasive surgery
Periodontal regeneration minimally invasive surgeryPROCEDURE

Conventional periodontal regeneration minimally invasive surgery without use of a videoscope

Periodontal regeneration minimally invasive surgery
Guided tissue regeneration surgeryPROCEDURE

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

Guided tissue regeneration surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois, Chicago, College of Dentistry, Periodontics

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Salvador Nares, DDS, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvador Nares, DDS, PhD

CONTACT

312-413-5787snares@uic.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Department Head

Study Record Dates

First Submitted

February 4, 2022

First Posted

March 11, 2022

Study Start

May 1, 2022

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)