Videoscope-Assisted Surgery for Gum Disease

Overseen By Salvador Nares, DDS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Steroids, Antibiotics, Phenytoin, others

Disqualifiers: Diabetes, Hypertension, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 months

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants not take medications known to affect immunity or periodontal tissues, such as steroids, antibiotics, or phenytoin, in the previous 6 months. Participants also cannot be on chronic anti-platelet or anti-coagulant therapy.

What data supports the effectiveness of the treatment Videoscope-Assisted Surgery for Gum Disease?

Research shows that guided tissue regeneration (GTR), a key component of this treatment, is effective in regenerating periodontal tissues lost to gum disease. Many studies have documented its success in reconstructive periodontal surgery, making it a widely accepted procedure in dental practices. ^{1 2 3 4 5}

Is videoscope-assisted surgery for gum disease safe?

Research shows that minimally invasive procedures like videoscope-assisted surgery are generally safe, causing minimal trauma and discomfort while effectively regenerating gum tissues. ^{1 2 5 6 7}

How is videoscope-assisted surgery for gum disease different from other treatments?

Videoscope-assisted surgery for gum disease is unique because it combines guided tissue regeneration (GTR), which aims to regrow lost bone and tissue, with minimally invasive techniques that use a videoscope (a small camera) to enhance precision and reduce recovery time compared to traditional surgery. ^{2 4 5 8 9}

Research Team

Salvador Nares, DDS, PhD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for systemically healthy adults aged 18-70 with severe chronic periodontitis, evidenced by specific dental measurements and radiographs. Candidates must have good oral hygiene (plaque scores ≤20%) and be English-speaking to follow study procedures. Excluded are pregnant women, smokers, those on certain medications or with systemic disorders affecting healing, and individuals with non-isolated gum disease or certain dental restorations.

Inclusion Criteria

Individuals with plaque scores ≤ 20%

I speak English and can follow the study's requirements.

My teeth are healthy or successfully treated with no current issues.

Exclusion Criteria

Current smokers

I haven't taken steroids, antibiotics, or similar drugs affecting immunity or gums in the last 6 months.

My teeth are noticeably loose.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo periodontal therapy using either VMIS, MIS, or GTR techniques to improve clinical and radiographic outcomes

12 months

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with bone fill examined using radiographs and CBCT imaging

12 months

Treatment Details

Interventions

• Guided tissue regeneration surgery
• Periodontal regeneration minimally invasive surgery
• Videoscope-assisted periodontal regeneration minimally invasive surgery

Trial Overview The study tests if using a videoscope during minimally invasive surgery improves outcomes in treating severe gum disease compared to standard methods. Participants will be randomly assigned to one of three groups: videoscope-assisted surgery (test), traditional minimally invasive surgery (control 1), or guided tissue regeneration (control 2). Outcomes will be measured through digital radiographs and fluid analysis over a year.

Participant Groups

Group I: Videoscope-assisted periodontal regeneration minimally invasive surgery Experimental Treatment 1 Intervention

Videoscope-assisted periodontal regeneration minimally invasive surgery - Test group

Group II: Guided tissue regeneration surgery Active Control 1 Intervention

Guided tissue regeneration - Control Group 2

Group III: Periodontal regeneration minimally invasive surgery Active Control 1 Intervention

Periodontal regeneration minimally invasive surgery - Control Group 1

Guided tissue regeneration surgery is already approved in United States, European Union for the following indications:

Approved in United States as Guided Tissue Regeneration for:

• Periodontal disease
• Bone loss around teeth

Approved in European Union as Guided Tissue Regeneration for:

• Periodontal disease
• Bone loss around teeth

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Findings from Research

Guided tissue regeneration (GTR) procedures are significantly more effective than open flap debridement (OFD) in improving clinical attachment levels and reducing probing depths in patients with periodontal osseous defects, based on a structured review of various studies.

The addition of a particulate graft to the GTR barrier can enhance certain outcomes, such as vertical probing depth reduction, but does not affect intrabony outcomes, indicating that while GTR is effective, the choice of augmentation may influence specific results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration for the treatment of periodontal intrabony and furcation defects. A systematic review. Murphy, KG., Gunsolley, JC.[2022]

Guided tissue regeneration (GTR) is an effective technique for regenerating periodontal support lost due to periodontal disease, supported by substantial clinical and histological evidence.

Successful application of GTR requires addressing specific barriers and understanding the clinical indications for its use, ensuring optimal treatment outcomes for patients with periodontal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration in periodontal therapy. Wolff, LF.[2006]

In a randomized controlled trial involving 16 patients with chronic periodontitis, the addition of guided tissue regeneration (GTR) using a biocollagen membrane significantly improved clinical outcomes, including reduced probing pocket depth and increased clinical attachment level compared to open flap surgery alone.

The study suggests that GTR can enhance the treatment of intrabony defects, leading to better bone density and overall periodontal health, making it a valuable option in regenerative periodontal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiographic evaluation of periodontal intrabony defects by open flap surgery alone or in combination with Biocollagen(®) membrane: A randomized clinical trial. Elkhatat, EI., Elkhatat, AE., Azzeghaiby, SN., et al.[2020]

Guided tissue regeneration (GTR) significantly improves clinical attachment levels in patients with periodontal infra-bony defects compared to conventional open flap debridement, with a weighted mean difference of 1.11 mm, based on a review of 11 studies.

GTR also shows a lower risk of sites failing to gain 2 mm of attachment, with a relative risk of 0.58, indicating it is more effective in promoting tissue regeneration than traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration for periodontal infra-bony defects. Needleman, IG., Giedrys-Leeper, E., Tucker, RJ., et al.[2018]

The paper emphasizes the benefits of minimally invasive surgical techniques for periodontal regeneration and proposes new clinical parameters, such as papilla height loss and width of keratinized tissue, to improve decision-making in choosing surgical approaches for periodontal defects.

The updated decision trees, which incorporate these new parameters, aim to guide dentists in selecting the most suitable minimally invasive techniques, although further studies are needed to validate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Surgical Strategies in Regenerative/Reconstructive Periodontal Therapy. Barbagallo, G., D'Urso, U., Psaila, A., et al.[2021]

Guided tissue regeneration (GTR) is an effective dental technique that promotes bone healing before soft tissue can invade the area, which is crucial for successful periodontal and implant surgeries.

The technique utilizes specialized membranes to block soft tissue migration, allowing for better osseous regeneration, and the paper reviews various materials currently available for these membranes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration in dentistry. Ziccardi, VB., Buchbinder, D.[2016]

Minimally invasive periodontal surgery techniques, including MIS, MIST, and VMIS, utilize small incisions that reduce trauma and preserve blood supply, leading to better regenerative outcomes for periodontal tissues.

These procedures result in minimal aesthetic issues and little to no discomfort for patients, making them a reliable option for periodontal tissue regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Videoscope-Assisted Minimally Invasive Surgery (VMIS) for Bone Regeneration around Teeth and Implants: A Literature Review and Technique Update. Harrel, SK.[2020]

Guided tissue regeneration (GTR) significantly improves clinical outcomes in periodontal treatment compared to conventional open flap debridement, with an average attachment gain of 1.22 mm and greater reductions in probing depth.

While GTR shows promise in enhancing periodontal healing, the variability in study results and unclear factors affecting outcomes suggest that further research is needed to better understand its clinical benefits and optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Guided tissue regeneration for periodontal infra-bony defects. Needleman, I., Worthington, HV., Giedrys-Leeper, E., et al.[2020]

Guided tissue regeneration (GTR) significantly improves clinical outcomes in periodontal treatment compared to conventional open flap debridement, with an average attachment gain of 1.22 mm and greater reductions in probing depth.

While GTR shows promise in enhancing periodontal healing, the variability in study results and unclear factors affecting outcomes suggest that further research is needed to better understand its clinical benefits and optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration for periodontal infra-bony defects. Needleman, IG., Worthington, HV., Giedrys-Leeper, E., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration for the treatment of periodontal intrabony and furcation defects. A systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration in periodontal therapy. [2006]

3. India pubmed.ncbi.nlm.nih.gov

Clinical and radiographic evaluation of periodontal intrabony defects by open flap surgery alone or in combination with Biocollagen(®) membrane: A randomized clinical trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration for periodontal infra-bony defects. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Minimally Invasive Surgical Strategies in Regenerative/Reconstructive Periodontal Therapy. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration in dentistry. [2016]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Videoscope-Assisted Minimally Invasive Surgery (VMIS) for Bone Regeneration around Teeth and Implants: A Literature Review and Technique Update. [2020]

8. England pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Guided tissue regeneration for periodontal infra-bony defects. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Guided tissue regeneration for periodontal infra-bony defects. [2022]