Utilization of a Videoscope in Periodontal Regeneration

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275192
• Other study ID #: 2021-1311
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: University of Illinois at Chicago
• Contact: Salvador Nares, DDS, PhD
• Phone: 312-413-5787
• Email: snares[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
United States	University of Illinois, Chicago, College of Dentistry, Periodontics	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Level	Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).	6 months
Primary	Probing Depth (PD)	Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus.	6 months
Primary	Gingival Recession (GR)	Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).	6 months
Primary	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
Primary	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
Primary	Clinical Attachment Level	Measured in mm as the periodontal probing depth (PD) plus gingival recession (GR).	12 months
Primary	Probing Depth (PD)	Measured in mm as the distance from the gingival margin (GM) to the base of the gingival sulcus.	12 months
Primary	Gingival Recession (GR)	Measured in mm as distance of the gingival margin (GM) to the cemento-enamel junction (CEJ).	12 months
Primary	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
Primary	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	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.	6 months
Secondary	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.	12 months