jeudi 8 septembre 2011

Bone Graft Alternatives - Magitech M2I Implant

Implant placement in reduced bone volume
For thirty years, implant placing has been a predictable and repetitive technique realized on young adults as well as elderly both in the maxilla and mandible with a success rate of more than 95% at 15 years old (Zarb and Schmitt 1990).

Vertical and transversal bone insufficiency is a common limitation of implant rehabilitation. It takes place to the detriment of the external cortical bone and lead to bone resorption and remodelling following extraction, infection, trauma or physiological. In this case, placing an implant is rather locally contraindicated and necessitates a prior treatment by means of onlay or vertical autogenous graft using either biomaterials or according to a guided bone regeneration technique with membrane or mesh. It requires a prolonged healing delay, from three to six months according to the type of the clinical case and more important post-operatory follow-ups.
We herein present the placement of M2I-MAGITECH implants as bone expanders of narrow ridges less or equal to 3mm in quality I or II of corticalized bone at the mandible and without any prior grafting at the maxilla. A second intervention is unnecessary enabling a global treatment cost reduction.
M2I-MAGITECH implants offer an ideal shape for bone expansion, very conical (better primary stability), with a reduced apical diameter from 1.5mm to 2.5mm according to the coronal diameter.
They are easily placed using a handle with insertion forces higher than 70N/cm. Their conicity enables lesser apical osseous constraints and a reduced bone heating by decreasing the number of drilling. This implant is of titanium alloy (TI6AL4 GRADE V) which mechanical features are 4 times higher (895 MPA traction resistance) than GRADE 1 COMMERCIALLY PURE TITANIUM (240 MPA) (Carr et al. 1997).

PRE-OPERATIVE ASSESSMENT

The pre-operative assessment which is a prerequisite fundamental step to any implantation act, commits the practitioner to study the relevance of the prosthetic project.

Any oral surgical act, simple or complex (bone surgery, implantology) requires a medical approach, based on a pre-operative assessment including notably a questioning and an exo- and endo-oral clinical exam. The ensuing observations and interrogations should lead us to reasonably prescribe complementary medical, biological or x-ray exams. Biological exams and the different expert advices will help evaluate the general condition of the patient, point out the contra-indications or the precautions to take when performing this act.
Medical imaging is a major important component in implantology where it evaluates the local and loco-regional condition. 2D x-ray evaluates infectious foyers, teeth that need extraction and implant feasibility.
Denta Scan and cone beam, 3D are used to assess bone deficiency. It confirms bone atrophy and specifies the available bone amount and the vestibular and palatine anatomical structures.
A moulding study with a resin prosthetic preparation helps visualize the final implant rehabilitation (number of teeth, occlusal ratios, implant positioning).
A radiographic guide is performed and will be modified into a surgical guide to allow positioning the implants according to three planes in space and to the final prosthesis desired by the patient.

SURGICAL TECHNIQUE

An antibioprophylaxy: Augmentin 2 g and SOLUPRED 60 mg are given the day of the scheduled surgery, one hour before the intervention.

Interventions are performed under local anaesthesia after a peri and intra oral disinfection using 2% chlorhexidine or yellow betadine periorally or green betadine intraorally. The surgical zone is infiltrated with an adrenaline cartridge (DENTSPLY) thanks to its para-apical needle.
A full thickness crestal incision is made using a 15c scalpel blade extending the length of the edentulous area. It is continued with a slightly displaced buccal and lingual incision at the mandible and only buccaly at the maxilla.
The periosteal separation procedure is performed using molt periosteal elevator or a chompret syndesmotome. Using oschenbein scissors allow for scar mucous tissue dilacerations.
Osseous zone is then exposed delimitating the implant site. Mandibular bone crest presents a bucco-lingual thickness of 2.5mm represented thanks to a periodontal probe.
No further bone expansion or associated graft has been performed. A transverse osteotomy with crestal separation using a diamond disk or a piezosurgery according to a technique described by Vercellotti in 2001 has not been performed. Conical bone expander (Halberstam 2007) hasn’t been necessary to prepare the implant site.

At the mandible, two M2I-MAGITECH implants are to be placed in positions 34 and 44 (Clinical case 2).

Implant protocol MAGITECH M2I

A 0.5mm KOMET round bur is used to make a pre-hole according to the desired axis
A pilot drill of 1.5mm diameter is placed along the length of the predefined implant and then a MAGITECH 2mm diameter drill is used to finish the implant osteotomy to place the 3.3mm diameter M2I-MAGITECH implant.
Minimal drilling is sufficient even in highly corticalized bone as the apex diameter is only 1.5mm for a 3.3mm implant.
The implant and its titanium holder are transferred from their sterile capsule to be placed into the implant site using a ratchet wrench or a handle.
During the insertion into the implant site that was only prepared using two drills (1.5mm and 2mm), clinical case 2, M2I-MAGITECH implant penetrates the implant site (Figure 1 and 2) thanks to the patented angulated and double-conical threads. This implant enables a condensation but more importantly bone expansion without any risk of fracturing the external cortical bone.
M2I-MAGITECH implant may be inserted with insertion forces higher than 70N/cm without any apical osseous constraints because its apex is highly conical and allow for less bone heating as the apical osteotomy is reduced by 30%.
During its insertion, (clinical case, figure 3 and 4), we could observe a voussure and a cortical expansion with horizontal bone gain of 1.5mm to 2mm, required to securely placing a 3.3mm implant. This expansion is stable for a long term period even after uncovering the implant.
If the cortical bone surrounding the implant is less than 1.5mm or in presence of a crack, bone rearrangement maybe necessary using onlay synthetic biomaterials or xenografts (Bio-Oss Geistchlich) or autogenous bone grafts covered with Bio-Gide collagen membrane (Geischtlich) such as Janson (TLBM) or platelet derivatives (PRF) after preliminary blood test.
Bone healing delay following M2I-MAGITECH implant placement is only 6 weeks without filling as it presents a very high primary stability at insertion and motionlessness without micro-movements facilitating osteoblastic adhesion at the bone/implant interface.
In the present clinical cases, a bone rearrangement has been performed and all implants have been inserted and covered with a cover screw.
The second intervention was performed 12 to 14 weeks later because of bone rearrangement and after performing an x-ray.
Check-up 2D x-rays have been performed on the day of the intervention, 15 days, 1 month and 3 months later. A cone beam was realized 3 months later.
Healing screws and MAGITECH abutments were placed using a MAGITECH dynamometric wrench at 35N/cm to make the prosthesis.

At the maxilla presented in the CLINICAL CASE 1, the patient presented a series of interventions:
-          Iliac onlay bone grafting, resorbed
-          GBR technique, 3 months LATER
-          FRIALITE IMPLANT (FRIADENT) in 11, overhanging at the buccal mucous, upper position, non utilizable aesthetically.
Crestal displaced and intra-sulcular incisions in palatine around 21 and 12 followed by a two vertical vestibular releasing incisions have allowed separating the muco-periosteal flap and giving access to the surgical site.
After excising the Friadent implant, the crest had a buccal-lingual bone thickness of 1.5mm which is not suitable to place M2I-MAGITECH implant.
Bone expansion by means of ridge splitting was developed by Tatum H in 1979 and resumed by many others (Scipioni 1994, Bravi 2007). This technique is used to sufficiently widen the ridge transversally. Two vertical corticotomies were outlined using a diamond saw (komet°) before placing the M2I-MAGITECH implant in order to perform the vestibular cortical bone expansion.
The M2I-MAGITECH implant’s double conicity allows succeeding an external cortical splitting safely, without fracturing the bone plate.
The simplicity of this technique is an advantage compared to autogenous bone grafting which presents variable results (A basa et al. 2004) necessitating a second painful operating site or biomaterial grafting according to the GBR technique (Dahlin 1988, Buser 1994) which is much more restricting to the patient.
M2I implant presents a high primary stability and an improved delay of bone healing. The second intervention is already possible after 6 weeks and prevents a prerequisite surgical bone rearrangement which reduces the global cost of the treatment.

POSTOPERATORY FOLLOW-UP

Antibiotherapy, Augmentin 1g in the morning and at night for 8 days, paracetamol-dextopropoxylene and chlohexidine are also given for a week.

After the placement of MAGITECH implants, a removable prosthesis emptied at the operated site will prevent any pressure on the operated zone. At the mandible (clinical case 2), healing abutments are placed, the gum is sutured in a higher position in order to delay epithelial migration according to a technique described by Prichard in 1957. Check-up x-rays were performed 15 days, 1 month and 4 months after the intervention.
An M2I-MAGITECH 15 degrees angulated abutment (clinical case 2) was placed at 18 weeks followed by a definitive ceramo-metal crown placement at 20 weeks.

The convex ridge profile obtained without mucous rearrangement is only due to osseous support after bone expansion and overfilling surrounding the implant which transformed this thin biotype into a thick biotype.

Discussion

The advantage of placing small diameters M2I-MAGITECH implants in narrow ridges is to eliminate any constraints related to a delicate surgery or inaccessible surgery for some. Its simple placement and exceptional primary stability allow reducing the healing period necessary for osteo-integration. Many studies (Mazor 2004, Romeo 2006 and Sennerby 2008) have shown a success rate over 96% for 3.3mm implants.
We could have performed a preliminary bone expansion to increase the crestal buccal-lingual diameter and suitably place the implant. However, this latter would have been too buried with a less functional prosthetic height and less esthetical result.
Using conic MAGITECH implants allow secure horizontal placement as the implant’s apex is pointy and has the same diameter as the last used drill instead of the diameter of the coronal implant. Its insertion into the bone enables a transversal bone gain and gives along a more convex volume and profile to soft tissues, thus improving the aesthetics.
Two studies (Sethi et al. 2000 and Simion et al. 1992) relate transversal bone expansion techniques at the maxilla and mandible with an immediate one-stage implant placement using a non-resorbable membrane according to the guided tissue regeneration principles.
Other authors, such as Pikos in 1992, use biomaterials to fill in the space after separating the bone wall with a postponed implant placement.
Bravi et al. 2007 has shown comparable results after alveolar split expansion and immediate 3.75mm and plus implant placement.
According to Princ and Piral in 2008, the splitting could hardly regain the too marked oblique feature of bone walls. A minimum of 3mm crestal width is required and presence of sponge bone is necessary between the external and internal cortical. High bone density makes splitting more difficult.
The most predictable technique for us was presented recently by Khoury et al. in 2010 at the mandible and consisted of a controlled osteotomy. In this case, stabilization and expansion are ensured using a lateral screw osteosynthesis.
Moreover, expansion doesn’t make up for a crestal delay of more than 3mm. Onlay autogenous bone grafting are thus necessary to improve the esthetic which necessitates a second operating site with a morbidity risk for the donor site.
According to Princ and Piral in 2008, grafting success criteria are:
Ø  Stabilizing the graft using screw osteosynthesis
Ø  Absence of hiatus between the graft and the receiving bed
Ø  Absence of prominent edges on the graft which may disrupt gum healing
Ø  Flap repositioning under tension
Ø  A follow-up during the first weeks is crucial to the only bone graft survival

The MAGITECH implant safely tackles implant treatment in narrow ridges (less than 4mm) and prevents much heavier techniques that could be restricting to the patient. The intervention is simpler and the healing delay is reduced to six weeks compared to 16 weeks in grafting and expansion techniques and 24 weeks if the implant is postponed.
The transversal expansion technique is delicate and necessitates a skilful knowledge of the operating act, when splitting the bone, placing simultaneously the implant using bone expanders, before placing the implant. M2I-MAGITECH implant placement prevents such constraints and the preliminary expansion procedure.
In ridges less than 2mm, an expansion technique by transversal osteotomy is required to increase the diameter to 1-2mm, without using an expander as the MAGITECH implant is able to play that role. Placing other implants would have required a prerequisite bone rearrangement, more restricting, with a longer healing delay and more important follow-up operations.

Conclusion

Placing M2I-MAGITECH implants in narrow ridges higher than 2mm limits the resort to bone sampling which necessitates a second operation site or the distraction technique which prevents eventual morbidity of the donor site.

Bone expansion techniques are not simple to realize and requires perfect knowledge of the surgical skill.
Using conic implants allow bone insertion with less osseous constraint and less heating thanks to its reduced apical diameter by 30% compared to cylindrical implants.

Magitech Implant Characteristics

Other implants have notably a time consuming inconvenience when placing the implant and present a number of difficulties during the insertion such as the anchoring which became rather difficult because of bone volume and quality.         Besides, these implementation-related difficulties facilitate bone heating and equally influence on implant stability and healing quality. Moreover, as bones become more fragile as does the risk of fracture. In other words, a long surgery with numerous drills implies an overheated bone and hence a more difficult healing. Likewise, proportions of bone volume, especially the width of the bone ridge which is often too narrow, may require a transversal bone expansion using a bone graft and a manual bone expander or contra-angles to lengthen the break time.
INVENTION REPORT
          Magitech Implants – M2I aim to address the disadvantages of the surgical placing of an implant by presenting a dental implant that is capable to assure a reduced break time and an enhanced quality of implantation for all bone types by putting aside the use of bone grafts and other expanding techniques. Altogether, M2I allow for an increased stability of the implant. Because of its      double conical shape:
-     The first relative nominal conicity with a tronconical-shaped anchorage body presents a defined lateral surface such as a tronconical envelope that is delimited by the threads’ summit and which angle is comprised between 1o and 15o;
-     The second relative conicity with a tronconical-shaped anchorage body presents a defined lateral surface such a tronconical envelope delimited by the threads’ crests and which angle is comprised between 5o and 20o;
 And its narrow apical diameter:
·         The apical part consists of an apex nominal diameter comprised between 1mm and 3mm for an implant diameter comprised between 3.3mm and 5.2mm and a threading which threads are angled between 50o and 54o.

          Therefore, such device presents the advantage of being self-tapered and expander at the same time. In fact, this self-tapered effect is due especially to the double conicity of the anchorage body while the expander effect is in part possible due to the angle variations of the threads as well as the important double conicity. This also allows for a much easier insertion of the implant into the bone and hence reducing the time and improving the healing.

The implants also allow for a conspicuously instant stability when in place. It is also possible to correct the direction of an implant during the insertion in the bone to favourably guide it along the prosthetic axis; i.e the axis that is capable of receiving the implant or even better to align it with another implant. In this latter case, a known handle for this technique may be used to assist the placement of this implant in order to align it.

            Beneficially, the threading on the anchorage body comprises an increasing depth of threads as it goes away from the support head and is comprised between 0.6mm and 0.7mm at the apical part. This depth of threads is more precisely defined as the distance between the crests and the summits of these threads.

          Furthermore, according to another characteristic, the support head is relatively cylindrical and includes a fairly circular upper surface and a lateral surface with a stabilizing threading that is capable to stabilize bone expansion after blocking the implant. Threads are separated by a 0.10mm to 0.50mm distance.

          According to a special feature, the implant is composed of a titanium alloy grade V which enhanced its mechanical qualities.
Surgical placement of the Magitech Implant – M2I comprises the following steps:
           -                   First, using a round bur of 0.5mm diameter makes a pre-hole along the desired axis;
           -                   Place the first drill of 1.5mm diameter according to the length of the implant then a second drill of 2mm nominal diameter to finish the implant osteotomy; i.e finish the bone drilling to place the implant. A minimal drilling is sufficient even in case of corticalized bone as the apex diameter is only 1.5mm for an implant of 3.3mm.
           -                   Both implant and titanium implant holder are retrieved from their sterile capsule and placed in the implant site. The use of a handle may eventually be helpful for insertion, especially when the implant must respect a certain alignment.
When inserting the implant into its site, it will easily penetrate it because of its high conicity and allows not only condensation but also bone expansion that is free from the risk of fracturing the external cortical, i.e bone crust.
Beyond its characteristics, the easy insertion into the bone allows such a dental implant to be adaptable to simple or complex clinical situations. It is possible to correct the direction of the implant during its insertion into the bone to guide it more favourably along the prosthetic axis or to align it to other implants. Besides, placing implants in patients with severe resorption, in presence of an insufficient bone width allows a progressive expansion of the vestibular bone surface by modifying the bone elasticity. Then, the implant plays the role of the expander by leverage.
          Finally, another advantage is the gain of time due to a reduced sequence of drills. A minimal drilling less than 2mm from the implant diameter is sufficient to place the implant in the jaw with a very good primary anchorage. Lesser bone heating and an improved bone healing rapidly procure a stabilization of the implant site and facilitate rapid insertion.
When realizing such a process, the implant site needs to be prepared only with the first and second drill of 1.5mm and 2mm, respectively, to place the implant which base has a nominal diameter of 3.3mm or 3.75mm. Nonetheless, other drills may be used. For example, to place an implant with a nominal diameter of 4.2mm, the use of a 2.8mm diameter for the first drill and 3.2mm diameter for the second drill is preferred.

Furthermore, as described, this implant may be inserted with an insertion force higher than 70N/cm without forcing the apical bone. This is the result of a high conicity at the apex allowing it also to reduce bone heating. Particularly, apical osteotomy is reduced by 30% which in other terms mean that bone matter indentation is reduced by 30%.
          It has also been noted that, during the insertion, a cortical expansion and voussure with a horizontal bone gain of 1.5mm to 2mm is necessary to securely place the implant, in case the implant’s base has nominal diameter of 3.3mm. This expansion is stable for a long term even after uncovering the implant.
          If the cortical bone surrounding the implant is less than 1.5mm or in presence of a crack, bone rearrangement by apposition may be necessary, using for example synthetic biomaterials or xenografts or autogenous bone grafts covered with a collagen membrane or platelet derivatives after preliminary blood test.
          Bone healing delay after placing such an implant is about 6 weeks, without filling as it presents a very high primary stability to insertion and motionlessness without any micromouvement which facilitates osteobasltic adhesion at the bone/implant interface. Osteoblasts are young bone cells that participate in ossification and then transform into osteocytes.
CONCLUSION

          This implant is indicated in cases of narrow ridges comprised between 2 and 4mm in which placing an implant in a one-step surgery would be impossible. Magitech S implant acts as a bone expander: it proved its efficacy in highly corticalized mandibular ridges. Its effortless insertion into the bone allows it to be adaptable to any simple or complicated clinical situation. It is possible to correct the direction of a Magitech S imlant during its insertion into the bone to favourably guide it along the prosthetic axis or to align it to other implants. The use of an implant holder handle during the insertion is recommended in this case. Placing a Magitech S implant in patients with severe resorptions, in presence of an insufficient bone width, allows a progressive expansion of the vestibular bone base by modifying bone stability. Magitech S implant plays the role of the expander by leverage.