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NCT Number: NCT05275192

Utilization of a Videoscope in Periodontal Regeneration

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Conventional periodontal regeneration minimally invasive surgery without use of a videoscope

Guided tissue regeneration surgery

Procedure

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

Primary outcomes

  1. Clinical Attachment Level

    Time frame: 6 months

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

  2. Probing Depth (PD)

    Time frame: 6 months

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

  3. Gingival Recession (GR)

    Time frame: 6 months

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

  4. Radiographic Bone Height (RBH)

    Time frame: 6 months

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

  5. Radiographic Bone Volume (RBV)

    Time frame: 6 months

    Measured in cubic mm as the volume of bone from the alveolar crest (AC) to the base of the alveolar bone defect (ABD).

  6. Clinical Attachment Level

    Time frame: 12 months

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

  7. Probing Depth (PD)

    Time frame: 12 months

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

  8. Gingival Recession (GR)

    Time frame: 12 months

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

  9. Radiographic Bone Height (RBH)

    Time frame: 12 months

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

  10. Radiographic Bone Volume (RBV)

    Time frame: 12 months

    Measured in cubic mm as the volume of bone from the alveolar crest (AC) to the base of the alveolar bone defect (ABD).

Secondary outcomes

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Salvador Nares, DDS, PhD

CONTACT

[email protected]

312-413-5787

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2022
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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