Inion GTR Biodegradable membrane

The Inion GTR Membrane is the first-ever membrane that is soft when applied but becomes rigid, once fixed in position. The key advantage of this is the ability to maintain space between soft tissue and bone, thus allowing for a large bone volume to be regenerated. Pre-clinical studies suggest a bioactive agent in the membrane may facilitate faster bone regeneration. The agent elutes out following implantation.
Biodegradable Inion GTR tacks can be used to fasten the membranes. The membrane provides a barrier for 8-12 weeks in vivo and resorbes thereafter.
The biodegradable membrane is initially rigid. Applying the plasticizer temporarily softens the membrane allowing for easy cutting and shaping. Once positioned at the surgical site, the membrane stiffens and attains 70 percent of its final strength in the first minute. This property permits space to be held for subsequent bone regeneration.
Inion GTR Biodegradable Membrane System implants are sterile, non-collagenous and non-pyrogenic.

Inion GTR Clinical applications

The Inion GTR Biodegradable Membrane System is indicated for the surgical treatment of periodontal defects (e.g. Class I and II furcation defects, intrabony defects and recession-type defects), for pre-implant and peri-implant surgeries and for covering bone defects and empty sockets.

Inion GTR features

• Safe, synthetic & biodegradable

• 3 layer structure providing stabilization & cell occlusion

• Easily adaptable due to plasticizer

• Improved space maintenance

• Preclinical studies suggested accelerated bone healing

Inion GTR Frequently Asqued Questions

1. What are the membrane and tacks made of?

They are made of an OptimaTM blend of rigid and elastic polymers selected for their strength, malleability and degradation properties. The polymers in the Inion GTRT Biodegradable Membrane System are:
Membrane — TMC Trimethylene Carbonate · LPLA L-lactide · PGA Polyglycolide
Tack — TMC Trimethylene Carbonate · DLPLA D, L-lactide

2. Why is the plasticiser needed?

The plasticiser is used to soften the membrane for ease of implantation.
The membrane becomes soft and pliable and can be easily adapted to the defect morhology.

3. What is the difference between Inion’s GTRT membrane and other biodegradable membranes?

The key difference is that the membrane becomes stiff when implanted. This allows the space under the membrane to be maintained so that more bone volume can be generated.

4. Why is there only one size of the membrane?

The size of Inion GTRT Biodegradable Membrane is large enough to cover all types of defects and can be cut using scissors to the required size. This makes a large inventory of different shapes and sizes unnecessary. For ease of trimming special templates are included in the membrane package.

5. What are the degradation times of the Inion GTRT membrane and tacks?

The Inion GTRT membranes and tacks are tailored to fully biodegrade within one to two years. The barrier function of the membrane to exclude gingival cells from the defect site is maintained for 8-12 weeks, thereafter the membrane starts to break down and biodegrade.

6. What happens to the membrane? What does it degrade into?

The GTR™ membrane degrades by hydrolysis and over time is metabolised through natural processes in the body into carbon dioxide and water, which are then exhaled and excreted.

7. Can you re-sterilise membranes and tacks if the packages have been opened but not used?

No, once the package has been opened the products may be contaminated and a successful re-sterilisation cannot be guaranteed. In addition, the re-sterilisation negatively affects the degradation behaviour of the implants.

8. Can the membrane be sutured in place?

Yes. The membrane can be fastened either with tacks or with biodegradable suture materials using a non-cutting needle. The material possesses excellent tear strength, allowing for proper suture fixation.

9. Are there any known tissue reactions to the plasticiser?

No. The ingredients in the plasticiser have been extensively tested and found to be safe and non-toxic. In addition, the concentration of plasticizer is so little that it cannot evoke any adverse reactions.

10. How fast does the membrane harden when exposed to water?

The membrane begins to stiffen as soon as it is exposed to water, saline or saliva. 50% of the maximum stiffness is reached one minute after exposure and reaches full rigidity 30 minutes.

11. What happens if you expose the membrane to the plasticizer longer than needed?

Overexposure of the GTRT to the plasticiser will affect its mechanical properties. It will become softer and may ultimately break when tension is applied.

12. How much time do I need for membrane preparation?

The membrane has to be soaked in the plasticizer for 20 seconds, then dried or “set” in the blister for 5-10 minutes. Imemdiately after the membrane should be briefly rinsed with water and is then ready for use.

13. What needs to be done if a soft tissue dehiscence occurs over the membrane?

If the dehiscience is reasonably small and there are no signs of inflammation with the membrane remaining intact, the membrane does not need to be removed. The membrane exposure will only insignificantly influence the degradation behaviour. Inion recommends increasing the frequency of wound inspection frequency, if such a dehiscence occurs, and to apply appropriate infection control.

14. Can the membrane be used in combination with bone graft susbtitutes?

Inion is not aware of any adverse reactions when using autologous bone graft or bone graft substitute in combination with the membrane.

15. Can I use more than one membrane at a time?

Yes. It is possible to use more than one preshaped membrane per surgery. However, Inion recommends that membranes do not overlap.

16. Can I use the membrane to prepare dental implant sites?

The Inion GTRT Membrane System is also indicated for bone augmentation around dental implants. Due to its outstanding space maintenance properties excellent bone volume gain may be achieved.

17. Which template should I use?

The H-shape template can be used for interproximal defects, the U-shape for intraosseous or distal defects and the “Apron-form” for dehiscence, receding and furcation defects.

18. Has the membrane been used clinically?

Yes. The membrane has been used successfully in both guided tissue regeneration and guided bone regeneration procedures. Inion is currently also undertaking further controlled studies.

19. How fast can I expect bone to regenerate underneath the membrane?

You can expect bone to grow at least as fast as with other membranes. However, ultimate results depend on a variety of factors which need to be assessed prior to surgery. The success of bone generation is verified by probing at follow up. Early animal study results indicate an acceleration of bone growth due to specific formulation of the membrane. Further research hereto is ongoing.