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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve surgeries for gum disease using a videoscope, a tiny camera that provides a better view during the procedure. The main goal is to determine if this camera helps dentists clean and repair damaged areas more effectively than traditional methods. Participants will be divided into three groups: one using the videoscope, one undergoing standard minimally invasive gum surgery, and one following a guided tissue regeneration approach (a type of surgery to help regrow gum and bone tissue). Individuals with severe gum disease (Stage III, Grade B periodontitis) and a specific type of bone loss around their teeth may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future dental procedures.

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 prior data suggests that this videoscope-assisted surgery is safe for gum disease treatment?

Research shows that using a videoscope in less invasive gum surgery can lead to better results. Previous studies found that this method, called V-MIS, is generally well-received by patients. Most improvements lasted over time, and no major safety issues emerged. The FDA has approved the videoscope, indicating its safety for similar procedures. Overall, evidence suggests this treatment is safe and has a strong history of positive outcomes in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about videoscope-assisted periodontal regeneration minimally invasive surgery because it offers a new level of precision and visibility during gum disease treatment. Unlike traditional surgeries, which rely on the surgeon's tactile skills and limited vision, this method uses a tiny camera to provide a clear view inside the gums. This could lead to more accurate tissue regeneration, potentially improving healing and outcomes. Additionally, this minimally invasive approach may reduce patient discomfort and recovery time compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for gum disease?

This trial will compare different surgical methods for treating gum disease. Research shows that using a videoscope to assist with minimally invasive surgery (V-MIS), one of the treatments in this trial, leads to better results than traditional methods. Studies have found that V-MIS provides lasting improvements, offering better visibility and precision during surgery. Patients have experienced positive outcomes that remain stable for several years after the procedure.

Guided tissue regeneration (GTR), another treatment arm in this trial, is a proven surgical method that helps regrow the tissues supporting teeth in advanced gum disease. Long-term evidence shows that GTR can keep severely affected teeth healthy for decades.

Periodontal regeneration minimally invasive surgery, also tested in this trial, is another MIS technique that consistently improves gum health by enhancing treatment results and reducing discomfort after surgery. Overall, these treatments show promise in improving gum health and saving teeth affected by severe gum disease. ^{6 7 8 9 10}

Who Is on the Research Team?

Salvador Nares, DDS, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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%

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

I have a tooth with gum disease showing deep cleaning needs, bleeding, and enough gum attachment.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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) 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11406001/

Guided tissue regeneration for periodontal infra-bony defects Guided tissue regeneration (GTR) is a surgical procedure that aims to regenerate the periodontal tissues when the disease is advanced.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1773224722002519

An overview of guided tissue regeneration (GTR) systems ... GTR systems are capable of acting as drug carriers for the targeted and prolonged delivery of drugs into the oral cavity with fewer side effects.

3. mdpi.com mdpi.com/2073-4360/15/16/3355

Guided Tissue and Bone Regeneration Membranes This comprehensive review provides an in-depth analysis of the use of biomaterials in the processes of guided tissue and bone regeneration.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8151433/

Periodontal Wound Healing and Tissue Regeneration The aim of this review article is to provide an overview of periodontal wound healing and discuss various surgical and pharmaceutical approaches.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jcpe.13302

Tooth survival and clinical outcomes up to 26 years after ... Our data show that more than 50% of the initially seriously diseased teeth were still in situ up to 26 years following GTR therapy despite an overall limited ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25039580/

Videoscope-assisted minimally invasive periodontal surgery ... A videoscope to assist minimally invasive surgery (MIS) has been developed. The clinical outcomes from MIS performed using this videoscope (V-MIS) are reported.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28183218/

Videoscope Assisted Minimally Invasive Surgery (VMIS) Improvements from VMIS appear to be favorable when compared with previously reported results of periodontal regenerative surgery. All improvements were stable ...

8. researchgate.net researchgate.net/publication/301562387_Videoscope-Assisted_Minimally_Invasive_Periodontal_Surgery_One-Year_Outcome_and_Patient_Morbidity

Videoscope-Assisted Minimally Invasive Periodontal Surgery The aim of this study was to report the 1-year clinical outcomes from videoscope-assisted minimally invasive surgery (V-MIS).

9. withpower.com withpower.com/trial/phase-periodontitis-2-2022-0f617

Videoscope-Assisted Surgery for Gum Disease Clinical and preclinical studies confirm that regeneration of supporting tissues of teeth lost due to periodontal disease can be achieved using the ...

10. 2024.sci-hub.st 2024.sci-hub.st/6261/93c39521f622a6eccdbb4ced7cfc0ee6/harrel2017.pdf

Videoscope Assisted Minimally Invasive Periodontal ... Background: The 36 to 58 month clinical outcomes from videoscope assisted minimally invasive surgery (VMIS) are reported. Methods: Fourteen patients having ...