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

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This double blind, randomized, parallel study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for soft tissue volume augmentation around dental implants

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.

What data supports the effectiveness of the treatment Geistlich Fibro-Gide® vs Connective Tissue Graft for Dental Implant Soft Tissue Enhancement?

Research shows that connective tissue grafts are a well-established method for improving gum health and appearance around dental implants, often leading to better outcomes in terms of tissue thickness and esthetics. Additionally, soft tissue augmentation techniques, like those using connective tissue grafts, are known to enhance the appearance and health of the gums around implants, which is crucial for successful dental restorations. ^{1 2 3 4 5}

Is the use of Geistlich Fibro-Gide® and Connective Tissue Graft safe for dental implant soft tissue enhancement?

The subepithelial connective tissue graft (SCTG) has been widely used and is considered safe, showing excellent short- and long-term stability. It is popular and accepted in periodontal surgeries, with key factors like graft harvesting and potential complications well understood. ^{6 7 8 9 10}

How does the treatment using Geistlich Fibro-Gide® differ from other treatments for dental implant soft tissue enhancement?

Geistlich Fibro-Gide® is a collagen matrix designed to enhance soft tissue around dental implants without the need for harvesting tissue from the patient's palate, unlike traditional connective tissue grafts. This makes the procedure less invasive and potentially more comfortable for patients. ^{4 6 11 12 13}

Research Team

Donald S Clem III, DDS

Principal Investigator

Regenative Solutions

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States 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. [2022]

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

Does simultaneous soft tissue augmentation around immediate or delayed dental implant placement using sub-epithelial connective tissue graft provide better outcomes compared to other treatment options? A systematic review and meta-analysis. [2022]

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

Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. [2022]

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

Overgrowth of soft tissues after transplantation of a connective tissue graft for the treatment of gingival recession. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Soft tissue remodeling technique as a non-invasive alternative to second implant surgery. [2021]

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

The use of the subepithelial connective tissue graft to enhance both the aesthetics and periodontal contours surrounding dental implants. [2004]

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

The versatile subepithelial connective tissue graft: a literature update. [2017]

8. New Zealand pubmed.ncbi.nlm.nih.gov

The dome technique: a new surgical technique to enhance soft-tissue margins and emergence profiles around implants placed in the esthetic zone. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

The effect of soft tissue augmentation on the clinical and radiographical outcomes following immediate implant placement and provisionalization: a systematic review and meta-analysis. [2021]

10. India pubmed.ncbi.nlm.nih.gov

Soft Tissue Augmentation Using De-Epithelialized Free Gingival Graft Compared to Single-line Incision Subepithelial Connective Tissue Graft in the Management of Miller Class I and II Gingival Recession: A Randomized Controlled Clinical Trial. [2022]

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

Lateral Access Pouch Technique to Treat Implants With Gingival Recession. [2018]

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

Esthetic restoration of a single-tooth dental implant using a subepithelial connective tissue graft: a case report with 3-year follow-up. [2004]

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

Connective tissue grafting for improved implant esthetics: clinical technique. [2019]