NCT05275192 · University of Illinois at Chicago
Utilization of a Videoscope in Periodontal Regeneration
What this study is about
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).
View original scientific description
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.
Interventions
DEVICE
Videoscope-assisted periodontal regeneration minimally invasive surgery
Use of a videoscope to improve visualization of periodontal defect during minimally invasive surgery
PROCEDURE
Periodontal regeneration minimally invasive surgery
Conventional periodontal regeneration minimally invasive surgery without use of a videoscope
PROCEDURE
Guided tissue regeneration surgery
Conventional guided tissue regeneration surgery for periodontal regeneration without use of a videoscope
Primary outcome measures
Clinical Attachment Level
Time frame: 6 months
Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).
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.
Gingival Recession (GR)
Time frame: 6 months
Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).
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).
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).
Clinical Attachment Level
Time frame: 12 months
Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).
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.
Gingival Recession (GR)
Time frame: 12 months
Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).
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).
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 13, 2024 · Source of record for eligibility and locations