RootReplica™ – FAQ
General Questions about RootReplica
Today, there’s no therapy done after tooth extraction. What’s the need for RootReplica™?
RootReplica™ has two functions: it’s a primary wound treatment for the bone defect after extraction and it is a preventative treatment of bone loss after tooth extraction.
Clinical results reveal that the patients treated with RootReplica™ had less pain after the tooth extraction compared to patients without RootReplica™. This is ascribed to the closure of the bone defect and that RootReplica™ avoids dry sockets due to the loss of the coagulum, which is the reason for dolor post.
The atrophy of the alveolar bone is most pronounced within the first 6 months after the extraction. During this phase, RootReplica™ supports the wound closure by the regeneration of the gingiva, supports the surrounding structures (lamella) and the formation of new bone.
is there any need for action after tooth extraction?
The extraction of a tooth is a traumatic operation and is not at all physiological. If teeth would fall out naturally with no extraneous cause, this would be physiological.
What’s the advantage of RootReplica™ compared to an immediate implant?
Whenever an immediate implantation is possible - taking the higher risk of an immediate implantation into account - then an immediate implantation may be an option of choice.
The size of the bone wound emerging from the extraction is often larger than the implant. The wound treatment with RootReplica™ offers an optimal solution to provide bone as much as possible before implantation.
The rate of success of an immediate implantation is significantly lower than of implants inserted after 3-6 months. Thus, a later implantation in combination with RootReplica™ should improve the rate of success of the expensive prosthetic treatment.
May RootReplica™ be implanted at a delayed immediate implantation?
Yes, the moment of implantation gets very variable with RootReplica™. This is actually one major advantage of RootReplica™: As you perform a preventative treatment, you will find good conditions for any subsequent treatment during a long period of time (i.e. one to at least 12 months). This gives the patient the necessary time to decide about the subsequent treatment, or to save money to afford e.g. an implantation.
Material
What’s RootReplica™ made up of?
RootReplica™ consists of two components:
The implant comprises a composite material containing phase pure beta-tricalcium
phosphate and polylactide. Beta-tricalcium phosphate is the inorganic
matrix of natural bone. Polylactide is a bioplolymer that is degraded
by the body. Both biomaterial components are used very successfully for
years and show a high biocompability.
The included membrane is composed of polylactide such as other resorbable membranes.
How fast does RootReplica™ degrade?
The polylactide of the biomaterial implant degrades after approx. 4 weeks, so that the granules consisting of beta-tricalcium phosphate support the bone formation / regeneration in the bone wound.
The granules completely degrade after approx. 12 to 15 month, depending on many factors such as: volume of the defect, regeneration potential of the patient (age, sex, smoker, etc.)
The membrane degrades after approx. 8 weeks.
Does RootReplica™ degrade completely?
RootReplica™ consists of high-purity biomaterials of pharmaceutical quality and degrades without leaving any residue.
Is RootReplica™ completely synthetic?
RootReplica™ is produced from synthetic raw materials of pharmaceutical quality. Therefore, no cross-infections are possible.
Indications
Which alveoles can be medicated, which not?
Basically, the use of RootReplica™ is recommended for any kind of alveoles.
Front teeth: good advantage, because the alveolar crest is narrow and thus may collapse rapidly.
Canine teeth: good advantage, because the alveolar crest is narrow and thus may collapse rapidly.
Molar teeth: large wound area and therefore high risk of infection, a RootReplica™ clearly reduces this danger of infection.
Wisdom teeth: large defect which is not spontaneously repared by bone ingrowth.
What if a tooth can’t be extracted as a whole? Can RootReplica™ be implanted then as well?
Yes. RootReplica™ can always be implanted as long as the extracted tooth or parts of it can be formed. If a tooth is divided into two parts, both parts can be formed and implanted individually. Make sure to insert the single parts of RootReplica™ into the right cavity.
Can RootReplica™ be used for wisdom teeth?
Yes, as long as the tooth was pulled without any immoderate surgical invasion. The advantage of RootReplica™ is the growth of bone into the bone wound so that a gingival pocket, in which food particles can accumulate, remains less often.
What if an alveola is infected?
Basically: Follow the instructions for use !
Infections present a higher risk for failing of the therapy. Previous
experiences show that RootReplica™ can be inserted into infected
alveoles. Thereby, infected tissue must be excised as good as possible.
Local or systematic use of antibiotics may be advisable. The dentist has
to decide from case to case if the use of antibiotics is reasonable.
Can RootReplica™ be combined with antibiotics?
Basically: Follow the instructions for use !
Local or systematic use of antibiotics may be advisable. The dentist has
to decide from case to case if the use of antibiotics is reasonable.
Can RootReplica™ be combined with a membrane?
An additional membrane is not necessary, because the RootReplica™ already has a membrane. Therefore it’s closed directly with the provided polylactide in order to integrate the function of the membrane into the RootReplica™
Can I insert a RootReplica™ a couple of days later after extraction?
This is unfavorable. The blood clot formed in the meantime should not be changed. Or alternatively, the bone wound should be at least scratched open so that the RootReplica™ can bleed in.
Can I use RootReplica™ at a site with a collapsed bone wall?
Basically: Follow the instructions for use !
There is little experience of the effect of RootReplica™ with missing
buccal bone wall. Therefore, the application is not recommended here.
Can I get additional height of the jawbone crest?
Basically: Follow the instructions for use !
It’s recommended to choose the height of the RootReplica™
in such a way that the bone crest is approx. 1-2mm above the RootReplica™.
The RootReplica™ will swell, and therefore the RootReplica™
should not be done too high because of the risk of ingrowth of epithelial
cells in case of incomplete cover of the Replica. In principle, implant
rather a too small than a too big RootReplica™.
How many RootReplica™ can I implant ?
There is no limitation on the maximum number of RootReplica™ per patient.
Can I use RootReplica™ on bleeders / hemophiles?
Basically: Follow the instructions for use !
Yes. RootReplica™ has absorbing properties and the wound closure
takes place very quickly. Based on the experience of today, the consumption
of drugs doesn’t have to be discontinued. Special measures may be
necessary if a RootReplica™ gets lost.
Contraindications
When does RootReplica™ should not be inserted?
Basically: Follow the instructions for use !
- heavily infected alveoles
- if the RootReplica™ cannot be inserted completely into the bone
- bone defect with more than one wall collapsed
When does RootReplica™ should not be inserted?
Basically: Follow the instructions for use !
- heavily infected alveoles
- if the RootReplica™ cannot be inserted completely into the bone
- bone defect with more than one wall collapsed
At what medical condition I can’t implant a RootReplica™?
RootReplica™ should not be implanted if a disease exists or medical therapies are administered which may influence the healing of the bone wound.
The Fabrication Process of RootReplica™
How long does it take to fabricate a RootReplica™?
The fabrication takes about 5 to 10 minutes.
Is the fabrication of RootReplica™ complicated?
The fabrication of RootReplica™ is very simple and can be done by the assistance.
Does the fabrication need a specific training?
Although the fabrication of RootReplica™ is very simple and safe, a training is proposed by the manufacturer. This training will provide the latest experience with RootReplica™ and will thus give the user a maximum of security when making the first Replica for clinical application.
Does RootReplica™ need additional employees?
No. The fabrication of RootReplica™ is simple and can be done by the trained assistance.
Does the machine (Replicator) be disinfected?
The surface of the machine has to be disinfected with 80% ethanol or a comparable disinfectant. Therefore the machine is constructed in a way, that it can not be damaged by liquids poured over the device. However you need to unplug the Replicator first!
Which additional infrastructure do I need for RootReplica™?
You need 3% H2O2 and sterile saline solution, which you will find in all dental offices. Apart from the equipment kit containing the Replicator, a metal condenser and the heated condenser, you only need the impression gun. Everything else is delivered with the biomaterial.
How fast has the RootReplica™ be inserted into the alveolus after extraction?
The RootReplica™ should be inserted as fast as possible into the bleeding alveolus. In case the bleeding has already stopped, you should refresh the bleeding, before inserting the Replica.
Who can fabricate the RootReplica™?
The fabrication can be done by the dentist but also by the assistance after the proposed training.
Why is the exact size/fit of RootReplica™ so important?
A close contact of the porous RootReplica™ with the surrounding bony structures supports the ingrowth of bone cells into the structure. It is known from implantology that there is no osteointegration in case the distance between the implant and the bone (i.e. jumping distance) exceeds a certain value. In addition, the exact fit closes the wound towards the soft tissue from the gingiva.
Do I have to use the integrated membrane?
In case of using the RootReplica™, you are taking the risk of soft-tissue ingrowth from the gingiva. The membrane seals the RootReplica™ towards the epithelium which should lead to an optimized bony regeneration.
How long do I have to wait, until I can demould the RootReplica™?
As long as the RootReplica™ is warm it is very fragile. To be on the save side, wait until the Replica has cooled down to room temperature. Outside the Replicator, this will take approx. 1 minute.
Bone Regeneration
Implantation of a Titanium Implant
How long does it take until a titanium implant can be set?
Clinical studies have shown, that an optimal situation for setting a titanium implant is reached after a period of 6 months and more. But already after 3-4 months, bone formation allows for setting a titanium implant. In this case, you will find undegraded granules of the bone graft.
Which kind of titanium implants can I use after placing a RootReplica™?
You can implant any type of implant you want to. After the degradation of RootReplica™ and the formation of new bone, you will fins optimal conditions for any kind of implant.
Bridges
What advantages reveals RootReplica™ for subsequent treatment with a bridge?
RootReplica™ helps to prevent the loss of bone and therefore red esthetics will be improved.
Mode of action
Remains RootReplica™ in the body – will there be autologeous bone?
RootReplica™ reveals an interconnected porosity towards the surrounding bony walls, allowing for bone tissue ingrowth. With time, the biomaterial degrades completely and the free volume will be filled with autologeous bone.
How does RootReplica™ work?
RootReplica™ closes the bony wound of the extraction site (i.e. alveolus). The included membrane coronal of RootReplica™ prevents the ingrowth of soft tissue, where as distal, bone tissue can grow into the porous scaffold. Over time, the biomaterial degrades and frees more volume, which can be filled by autologeous bone. Thus, there are optimal conditions for the formation of new bone and that the alveolus will be filled completely with autologeous bone.
May RootReplica™ cause pain?
Clinical studies have shown, that patients treated with RootReplica™ report generally about less pain than patients without RootReplica™. With RootReplica™, patients have reported about feeling a slight pressure for about a week, which they did not describe as pain.
Can tissue grow into RootReplica™?
Yes. The surface of RootReplica™ towards the surrounding bony structures is macro porous, allowing for blood uptake. With the blood, also important factors for the formation of new bone are included into the scaffold. Thus, bone tissue can grow into the RootReplica™ already at an early stage.
Does RootReplica™ contain bio-active substances?
No. RootReplica™ consists of 100% synthetic biomaterials in phamaceutical pureness and does not contain any drugs, nor any bio-active substances.
Can bacteria grow on or into the RootReplica™?
In the clinical studies, bacterial invasion, respectively infection of the RootReplica™ was not observed. Due to the fact, that RootReplica™ contains polylactide, it can be assumed that it reveals a protection against bacterial invasion. Polylactide releases a small amount of lactic acid during degradation, which is used by the body to reduce bacterial growth of e.g. the skin or the female vagina.
Application
Do I have to cover RootReplica™ with a membrane or with gingiva?
No. After inserting RootReplica™ into the alveolus, no further surgical steps are mandatory. A membrane is already included in the RootReplica™. In some cases, suturing might bring an additional advantage for the bony regeneration.
Do I have to close the wound by suturing?
Yes. The RootReplica™ will remain in the alveolus after insertion without any further external support. It is important, that in case of a splitted root the replicas are inserted in the right alveolus.
Which controls are necessary after placing a RootReplica™?
As with any other extraction, it is recommended to control wound healing after 7 to 14 days.
Which complications can occur with RootReplica™?
Generally: consult the instructions!
What happens in case the RootReplica™ is lost before complete wound healing has occurred?
This has rarely been observed and is not a risk for the patient.
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