Geistlich Fibro-Gide® vs Connective Tissue Graft for Dental Implant Soft Tissue Enhancement

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Geistlich Pharma AG

Must not be taking: Steroids, Calcium channel blockers

Disqualifiers: Diabetes, Cancer, HIV, others

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

Compensation: Varies

Number of Visits: 3

Duration: Day 0

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Geistlich Fibro-Gide® performs as well as the traditional connective tissue graft in enhancing gum tissue around dental implants. Researchers aim to determine if Geistlich Fibro-Gide® can increase soft tissue volume, crucial for the stability and health of dental implants. The trial includes two groups: one receiving Geistlich Fibro-Gide® and the other a connective tissue graft. Suitable candidates for this trial should have dental implants with thin gum tissue and maintain good oral hygiene. As an unphased trial, this study provides an opportunity to contribute to innovative dental research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that compromise wound healing, such as chronic steroids, certain blood pressure medications, anti-seizure drugs, or treatments for bone diseases. If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Geistlich Fibro-Gide® is a well-tolerated treatment for enhancing soft tissue around dental implants. Studies indicate that this dissolvable collagen material is designed to thicken soft tissue, making it a promising choice for dental procedures requiring soft tissue growth.

The product is easy to use and has consistently increased tissue thickness in studies, demonstrating compatibility with the body and natural breakdown over time, which is crucial for safety.

Although specific data on side effects for Fibro-Gide® is not available, its ability to dissolve and maintain volume suggests general safety. This type of product is commonly used in dental and oral surgeries, supporting confidence in its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Geistlich Fibro-Gide® because it offers a unique approach to enhancing soft tissue around dental implants. Unlike traditional connective tissue grafts, which require harvesting tissue from the patient's palate, Geistlich Fibro-Gide® is a collagen matrix that eliminates the need for a second surgical site, potentially reducing patient discomfort and recovery time. Additionally, its porous structure promotes better tissue integration and stability, which could lead to more predictable and aesthetically pleasing outcomes. This innovative approach could simplify procedures and improve the overall patient experience in dental implant therapy.

What evidence suggests that this trial's treatments could be effective for dental implant soft tissue enhancement?

Research has shown that Geistlich Fibro-Gide® effectively increases the thickness of soft tissue around dental implants. Studies have found it easy to use and reliable. Geistlich Fibro-Gide®, a collagen matrix, helps build the soft tissue needed for dental implants. It maintains its shape and stabilizes blood clots, which are important for healing. In this trial, participants will receive either Geistlich Fibro-Gide® or a traditional Connective Tissue Graft to compare their effectiveness in improving soft tissue around dental implants. These benefits make Geistlich Fibro-Gide® a promising alternative to traditional tissue grafts. ^{1 2 5 6 7}

Who Is on the Research Team?

Donald S Clem III, DDS

Principal Investigator

Regenative Solutions

Are You a Good Fit for This Trial?

This trial is for individuals with good oral hygiene needing soft tissue augmentation around dental implants that have been in place for at least 6 months. Participants should not be on medications affecting wound healing, have untreated severe gum disease, uncontrolled diabetes, or a history of frequent nicotine use.

Inclusion Criteria

I can maintain good oral hygiene around my implant and nearby teeth.

I need soft tissue augmentation around an implant that has been in place for at least 6 months.

My bone graft or implant has been in place for at least 6 months.

Exclusion Criteria

History within the last 6 months of weekly or more frequent use of nicotine products

Participation within the last six months in other interventional studies

I do not have any infections in the area where surgery is planned.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Geistlich Fibro-Gide® or Connective Tissue Graft for soft tissue volume augmentation around dental implants

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of gingival soft tissue volume and adverse events

6 months

Visits at 2, 4, 12 weeks, and 6 months

Long-term follow-up

Participants are monitored for long-term safety and effectiveness, including assessments of gingival soft tissue volume and adverse events

1, 3, 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Soft tissue flap + Connective Tissue Graft
• Soft tissue flap + Geistlich Fibro-Gide®

Trial Overview The study compares Geistlich Fibro-Gide®, an alternative to connective tissue grafts (CTG), for increasing soft tissue volume around dental implants. It's a double-blind test where patients are randomly assigned to receive either the new material or traditional CTG.

How Is the Trial Designed?

Group I: Test Experimental Treatment 1 Intervention

Soft tissue flap + Geistlich Fibro-Gide®

Group II: Control Active Control 1 Intervention

Soft tissue flap + Connective Tissue Graft

Who Is Running the Clinical Trial?

Geistlich Pharma AG

Lead Sponsor

Trials

45

Recruited

2,300+

Medelis Inc.

Industry Sponsor

Trials

7

Recruited

480+

Published Research Related to This Trial

In a study of 14 patients with gingival recession around implants, the use of guided bone regeneration (GBR) with a resorbable membrane and allograft significantly improved both hard and soft tissue dimensions in the anterior maxilla after approximately one year.

Postoperative measurements showed significant increases in crestal bone thickness (1.84 mm) and mid-implant buccal bone thickness (2.07 mm), along with improvements in soft tissue thickness, keratinized tissue width, and gingival height, indicating the efficacy of this technique for aesthetic restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Labial Soft Tissue Recession Around Dental Implants in the Esthetic Zone Using Guided Bone Regeneration With Mineralized Allograft: A Retrospective Clinical Case Series. Le, B., Borzabadi-Farahani, A., Nielsen, B.[2022]

Citations

1. geistlich.us geistlich.us/product-support/fibro-gide-support/

Geistlich Fibro-Gide® Product Support Geistlich Fibro-Gide® is intended for soft-tissue augmentation. It is indicated for localized gingival augmentation to increase keratinized tissue (KT) around ...

2. geistlich-na.com geistlich-na.com/fileadmin/content/USA/Dental/PDFs/Product_Brochures/GPNA_brochure-FibroGide.pdf

Geistlich Fibro-Gide® Conclusion: Geistlich Fibro-Gide® is an easy to apply collagen matrix showing predictable results in soft tissue thickness augmentation around dental implants.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9877052/

Tissue integration and biodegradation of soft tissue substitutes ... Higher levels of compression led to delayed tissue integration. The effect of different compression levels was more distinct when compared to the differences ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K171050.pdf

Geistlich Pharma AG November 9, 2017 Janice M. Hogan ... Geistlich Fibro-Gide® is an implantable device intended for use in soft tissue augmentation procedures. As described in more detail below, the ...

5. geistlich.com geistlich.com/regeneration-academy/detail/out-of-the-palate

Out of the palate This article explores how Geistlich Fibro-Gide® contributes to gingival recession treatment by providing volume stability, blood clot stabilization, and an ...

6. geistlich.com geistlich.com/dental/products/matrices/fibro-gide

Fibro-Gide Geistlich Fibro-Gide is a porcine, porous, resorbable and volume-stable collagen matrix, specifically designed for soft-tissue regeneration.

7. geistlich.com geistlich.com/dental/treatment-solutions/soft-tissue-regeneration

Soft-Tissue Regeneration Geistlich Fibro-Gide® is recommended in submerged healing. for thickening the soft tissue around teeth and implants and under pontics; to cover recession ...