A pilot-study of a minimally invasive technique to elevate the sinus floor membrane and place graft for augmentation using high hydraulic pressure: 18-month follow-up of 20 cases

Vol. 116 No. 3 September 2013 A pilot-study of a minimally invasive technique to elevate the sinus floor membrane and place graft for augmentation using highhydraulic pressure: 18-month follow-up of 20 cases Philip Jesch, DMD,Emanuel Bruckmoser, MD, DMD,Andreas Bayerle, MSc, MBA,Klaus Eder, Michaela Bayerle-Eder, MD, Phand Franz Watzinger, MD, DMD, Dental Clinic Wienerberg City, Vienna, Austria; Morriston Hospital, Wales, UK; Jeder GmbH, Dental Technology, Vienna, Austria; PrivatePractice for General Dentistry and Implantology, Vienna, Austria; Medical University of Vienna, Vienna, Austria; and St. Poelten General Hospital,Austria Objective. To evaluate medical efficacy and safety of crestal, minimally invasive sinus floor augmentation (MISFA) using aninnovative method based on high hydraulic pressure.
Study design. Twenty MISFA using the novel Jeder-System were performed in 18 patients at 2 study sites in Vienna, Austria.
The Jeder-System consists of the Jeder-drill, the Jeder-pump, and a connecting tube-set. The pump generates high hydraulicpressure (1.5 bar) pushing back the sinus membrane from the drill at the first perforation. The pump also monitors the wholeprocedure by constantly measuring pressure and volume.
Results. Five percent membrane perforation rate (1/20) only detected in the postoperative computed tomography scan andwithout implication for implant placement. Height gain of 9.2  1.7 mm achieved (from 4.6  1.4 mm to 13.8  2.3 mm).
Average patient satisfaction was 9.82 on scale from 1 to 10 (10 ¼ very satisfied). Mean duration of sick leave was 0.19 days.
18-month survival rate was 95% (1/20 implant lost).
Conclusions. Within the limits of a prospective open cohort study with 20 cases, our data demonstrate the safety and medicalefficacy of the novel method. (Oral Surg Oral Med Oral Pathol Oral Radiol 2013;116:293-300) Although the lateral window technique using a modi- the development of a great variety of new methods over fied Caldwell-Luc approach still represents the standard the past 15 years. Recent publications on these modifi- procedure for sinus floor augmentation in the posterior cations cover the use of ballooand hydraulic maxilla region, patients frequently suffer from consid- pressure in humans,the appliance of a hydraulic sinus erable postoperative pain and swelling.
condensing technia gel-pressure technique,as Therefore, substantial efforts have been made to well as the use of "intelligent" drills.
develop less invasive techniques in order to reduce In a systematic review of 10 transcrestal sinus lift patient discomfort. As a first improvement of that kind studies, Tanidentified a reported membrane perfora- a transalveolar technique with subsequent implantation tion rate of 0%-21.4% (mean 3.8%). However, in was introduced by Tatumand further developed as an a parallel review of 33 clinical studies using the lateral osteotome technique by SummersThe controlled approach, Pjetureported a perforation rate of primary entry of the drill into the maxillary sinus and the 0%-58.3% (mean 19.5%). Based on this, safe elevation of the Schneiderian membrane without rightly doubts the validity of the numbers reported by perforation are the major challenges of this method. The Tan. As the lateral window technique is done with shortcomings of the Summers technique have motivated visual control, it seems unlikely that the perforation rateshould be much lower for "blind" procedures in which flict of interest is declared by P. Jesch, A. Bayerle, K. Eder, and M. Bayerle-Eder since these authors have commercial there is no more than the surgeon's tactile perception associations with the Jeder GmbH, Dental Technology, Vienna, to go by. Rather, we agree with Watzekand that using the transcrestal approach clinically insignif- aOral Surgeon, Dental Clinic Wienerberg City.
b icant perforations are generally not detected. Therefore, Registrar, Department of Oral and Maxillofacial Surgery, Morriston Hospital.
cCEO, Jeder GmbH, Dental Technology.
dOral Surgeon, Private Practice for General Dentistry andImplantology.
Statement of Clinical Relevance eAssociate Professor, Department of Internal Medicine III, MedicalUniversity of Vienna.
Currently there are only a few techniques for flapless fProfessor and Head, Department of Oral and Maxillofacial Surgery, minimally invasive sinus floor augmentation avail- St. Poelten General Hospital.
able. We present a novel procedure, which tackles Received for publication Mar 26, 2013; returned for revision May 6,2013; accepted for publication May 15, 2013.
shortcomings of other techniques, like secure entry Ó 2013 Elsevier Inc. All rights reserved.
into the maxillary sinus and controlled elevation of 2212-4403/$ - see front matter the Schneiderian membrane.
one can assume that the actual transcrestal perforation Table I. Subjects characteristics rates are much higher than those reported by Tan.
In his review, Tan also identified a reported mean Age range (years) implant success rate of 92.8% for transcrestal sinus elevations. However, Tan confirmed the finding ofRosthat the implant failure rate increased with and Data are presented as absolute numbers (n ¼ 18).
was correlated to reduced residual bone height.
It was therefore the aim of the present study to Table II. Number and position of sinus lifts according evaluate the safety and medical efficacy e in particular to the World Health Organization (WHO)/Fédération in terms of membrane perforation rate and 18-month Dentaire Internationale (FDI) system survival rate e of the novel technique for minimally No. of sinus lifts invasive sinus floor augmentation (MISFA) using the Position (WHO/FDI) Jeder-System (Jeder GmbH, Vienna, Austria).
Data are presented as absolute numbers (n ¼ 20).
MATERIALS AND METHODS selected for 20 MISFA with subsequent immediate Patient selection implant placement. The patient population consisted of Recruitment and selection of patients took place at the 2 11 women and 7 men aged 29-77 years (51  16 years).
study sites in Vienna, Austria, where the surgical In 2 subjects MISFA was performed bilaterally. A total procedures were to be performed. All subjects gave of 5 patients suffered from 1 or 2 of the following written informed consent to the protocol, which was in diseases requiring permanent medication: hypertension compliance with the Helsinki Declaration and had been (n ¼ 4), cardiac arrhythmia (n ¼ 1), hyperlipidemia approved by the Ethics Committee of the City of (n ¼ 1), restless legs syndrome (n ¼ 1). All patients Vienna, Austria. Study monitor was the Coordination Center for Clinical Studies of the Medical University of Sixty percent of the implants were placed in the Inclusion criteria were as follows: women and men position of the upper first molar and 40% were placed in aged 18 years or older, 1 or more missing upper first or the position of the upper second premolar (see second premolars or upper first or second molars, and The residual bone height was 4.6  1.4 mm. The bone atrophy in the posterior maxilla region resulting in a residual alveolar ridge height of <8 mm.
1.6  0.5 mm. The bone qualitywas as follows: type Exclusion criteria were as follows: residual alveolar 2 in 1 case, between type 2 and 3 in 3 cases, and type 3 ridge height of <3 mm impeding implantation directly in the remaining 16 cases (see after augmentation, Underwood septa localized in inten-ded implant position, sinus membrane thickness >5 mm, Surgical procedure maxillary sinusitis or polyposis, pregnant or breastfeedingwomen, poor oral hygiene, tobacco consumption of more All sinus lift procedures were performed by using the than 15 cigarettes per day, hypercortisolism, corticoid Jeder-System which is fully CE-certified and treatment, osteoporosis with intravenous bisphosphonate distributed by Jeder GmbH, Vienna, Austria therapy, subjects suffering from severe chronic diseases ). The system consists of the Jeder-drill as well as immune-suppressed patients.
(Jeder GmbH, Vienna, Austria) (the actual surgical tool)the Jeder-pump (Jeder GmbH, Vienna,Austria) and a connecting tube-set. The pump Pre-operative evaluation generates high hydraulic pressure (1.5 bar) in the pressure- A questionnaire, a clinical examination, a panoramic sealed system, thus pushing back the sinus membrane radiograph and a dental computed tomography (CT) scan from the drill at the slightest perforation of the remaining were performed to assess inclusion and exclusion criteria.
bone. The pump also generates hydraulic vibrations to Women of reproductive age had to submit a negative further raise and separate the membrane from the bone.
pregnancy test before every CT scan. In case of a positive The whole procedure is controlled by constantly mea- test result the CT scan would not be performed and the suring pressure and volume of the inserted fluid.
subject would not be included in the study.
A surgical procedure using the Jeder-System consists of the following steps:  Initially, a soft tissue punch (ATP-punch, DENTSPLY- From September 2010 through February 2011, a total Friadent, Mannheim, Germany) ) is used at number of 18 consecutive patients were recruited and the implantation site without mucoperiosteal flap

Volume 116, Number 3 Jesch et al.
Table III. Summary of pre- and postoperative clinical and radiologic data of the study Total postoperative (Lekholm/Zarb index SD, standard deviation.
*Sinus lift performed bilaterally in 1 session.
the membrane (At the same time, a suddendrop in pressure on the display of the Jeder-pumpindicates the successful first entry into the sinus tothe surgeon (  After the perforation of the remaining bone, the saline solution e which is set into hydraulic vibra-tions (50 Hz) by the Jeder-pump e further separatesthe membrane from the bone. Thereby, space for theaugmentation material and the implant is created.
After extraction of the saline solution using theJeder-pump the augmentation material and the Fig. 1. Jeder-System: pump with foot pedal, drill, and con- implant are inserted necting tubing set.
 The whole procedure is constantly monitored by continuous measurement of the pressure and volumeof the inserted fluid on the display of the Jeder-pump.
retraction. Then, the primary drill is taken until The Jeder-pump features a built-in security mechanism 1-2 mm below the sinus floor. To verify depth, an intra- to prevent introducing excessive pressure and fluid operative radiograph can be done volume: As each step on the foot pedal of the Jeder- Once the primary drilling has reached a sufficient pump injects only 0.2 mL of saline solution, there is no depth shortly below the sinus floor, the Jeder-drill is danger for the Schneiderian membrane after the plugged into the bore (pressure-sealed) ) perforation of the bone ("high pressure, but very and high hydraulic pressure (1.5 bar) is built up in the limited amount of liquid"). Additionally, all data are pressure chamber of the Jeder-drill using physio- electronically recorded for documentation purposes.
logical saline solution (NaCl). The centrally placeddrill within the pressure chamber of the Jeder-drill A combination of Ostim (Heraeus Kulzer, Vienna, slowly moves through the remaining crestal bone Austria) and Bio-Oss (Geistlich Biomaterials, Baden- toward the sinus floor ( Baden, Germany) was used as augmentation material.
 Upon the first minimal perforation of the remaining In total, 20 Ankylos screw type implants (DENTSPLY- fluid pushes back the Friadent, Mannheim, Germany) were placed immedi- membrane, ensuring that the drill does not perforate ately after MISFA. Implant diameters were 3.5 mm in

Fig. 4. The ATP-punch, developed by Prof. Dr. WolfgangJesch.
Fig. 2. The Jeder-drill consists of the guide-element and thecentrally placed drill.
Fig. 3. The Jeder-pump with control display, controlled byfoot pedal.
4 cases and 4.5 mm in 16 cases. Implant length was11 mm in all but 2 cases. One implant was 9.5 mm longwhile another one was 14 mm.
Fig. 5. The depth of the primary drill can be verified bytaking an intra-operative radiograph.
Peri- and postoperative carePrior to surgery local anesthetic infiltration was admin-istered buccally and palatally (articaine hydrochloride 4% implant load was 258  81 days. Prosthetic rehabilitation with epinephrine 1:100,000 [Septanest with Epinephrine; included single crowns in 12 cases, implant bridge Septodont, Niederkassel-Mondorf, Germany]). Postop- constructions in 6 cases (including 1 horseshoe implant eratively, patients were prescribed either clindamycin bridge), and removable partial dentures in 2 patients.
hydrochloride 300 mg (Clindac; Sandoz GmbH, Kundl,Austria) 3 times daily or josamycin 500 mg (Josalid; Clinical and radiologic follow-up Sandoz) twice a day, for 1-week period. Following On day 1 and day 3 after surgery, telephone follow-ups successful implantation the healing period until full were conducted. One week postoperatively, every

Volume 116, Number 3 Jesch et al.
Fig. 6. The sealing element of the Jeder-drill (Jeder GmbH, Fig. 8. The high pressure pushes the Schneiderian membrane Vienna, Austria) is pressed against the mucosa.
away from the drill.
absence of clinically detectable implant mobility, (2)absence of pain or any subjective sensation, (3) absenceof recurrent peri-implant infection, and (4) absence ofcontinuous radiolucency around the implant.
Statistical analysisDescriptive statistical analysis including calculation ofmean values and standard deviation (SD) of recordeddata was carried out with Statistica software (release6.0, StatSoft Inc., Tulsa, OK, USA). Data are presentedas means  SD.
Fig. 7. Hydraulic pressure is built up in the pressure chamber In total, 20 MISFA were performed in 18 patients. Main of the Jeder-drill (Jeder GmbH, Vienna, Austria) using data are summarized in physiological saline solution.
On the control CT scan performed 4-6 weeks post- operatively, a small amount of augmentation material patient completed a questionnaire including the degree was observed in a maxillary recessus in 1 out of 20 cases.
of overall patient satisfaction e by use of a visual analog Thus, the membrane perforation rate was 5%. The scale (VAS) (1 ¼ not satisfied, 10 ¼ very satisfied) e and patient did not show any clinical symptoms and there including the days of sick leave. Between 4 and 6 weeks was no implication for the implant placement. The after surgery, a clinical examination and a control CT respective patient is under close observation and at the scan were performed aiming at detecting possible post- 18-month follow-up there were no clinical symptoms related to this perforation of the Schneiderian membrane.
membrane perforation) as well as quantification of The control CT scan also showed that the residual height gained by the augmentation procedure. All CT bone height of 4.6  1.4 mm could be augmented to images were evaluated by 2 independent investigators 13.8  2.3 mm corresponding to a height gain of not involved in the surgical procedures.
9.2  1.7 mm.
Eighteen months postoperatively (562  34 days) Overall patient satisfaction with the surgical proce- implant stability was assessed in a clinical and radiologic dure was evaluated based on a questionnaire using [periapical radiograph and digital volume tomography a VAS ranging from 1 to 10 (1 ¼ not satisfied, (DVT)] examination. The survival criteria proposed by 10 ¼ very satisfied). Average patient satisfaction was Buser et and Cochran et were followed at the 9.82  0.7 points. The mean duration of sick leave was 18-month control. They included the following: (1) 0.19  0.5 days.
Fig. 10. The postoperative DVT shows the sinus lift and theimplant in situ.
method for cases with at least 3 mm residual alveolarridge height.
Height gainIt is widely accepted in the literature that crestalmethods currently in use are not predictable andreproducible if elevations >5 mm are needeHowever, in the present study the height gain rangedfrom 6 to 11 mm (mean 9.2  1.7 mm). In cadavericstudies it has been demonstrated that in a crestalapproach the Schneiderian membrane can be liftedmore than 10 mm without tearing.Membrane Fig. 9. The pressure-drop on the display of the Jeder-pump perforation can occur as soon as elevation forces exceed (Jeder GmbH, Vienna, Austria) indicates the successfulperforation of the remaining bone.
the load limits of the sinus memAs the Jeder-System uses hydraulic pressure, Pascal's principle ofeven pressure distribution appliesand allows opti- At the 18-month follow-up, none of the implants showed any mobility apart from 1 case where the concluded that the novel method can deliver a height implant was lost 9 months after surgery. Following gain that is comparable to the lateral approach.
insertion of a new implant at the same site 3 monthsafter explantation, the new implant is still in place andfunctions well according to the patient's feedback. The 18-month survival rate was therefore 95% (19 of 20 In the literature, perforation rates for indirect sinus implants). None of the remaining implants showed any floor augmentations usually vary between 0% and mobility, and there was no pain, redness, swelling, or 44%.In reality, microscopic tears are, in many suppuration at any implant site. None of the patients instances, impossible to diagnose and therefore their reported clinical symptoms of maxillary sinusitis, and incidence frequency is often underestimated.Some also the DVT did not reveal any case of sinusitis.
authorexplicitly state that small perforations(without clinical verification) might not have beendetected, which means that the perforation rates re- ported in their studies would be too low.
The main finding of our study is that e within the limits In an endoscopically controlled osteotome sinus of a prospective open cohort study with 20 cases e floor augmentation study, the validity of the Valsalva MISFA using the Jeder-System is a safe and effective Volume 116, Number 3 Jesch et al.
effectiveness to detect small perforations of the <4 mm, further studies are needed to verify that the Schneiderian membrane.In our study, CT scans were novel method can also yield high survival rates for sites undertaken before and 4-6 weeks after MISFA in all with pre-operative bone height of <4 mm.
patients. Additionally, all CT images were evaluated by2 independent investigators not involved in the surgical procedure. In one patient a small amount of augmen- All recorded side effects were considered slight or tation material was radiologically visible in the upper moderate. In particular, there were no signs of infec- recessus of the maxillary sinus without any clinical tion, sinusitis or nose bleeding after MISFA, while symptoms of sinusitis. Therefore, membrane perfora- one hematoma was observed after local anesthesia. It tion rate was considered to be 5% (1 of 20 cases). The could be shown that the novel method significantly perforation neither affected implant stability nor caused reduces side effects compared to the considerably any problems for the patient. At the 18-month follow- more invasive lateral approach. Thus, sick leave was up visit, the patient demonstrated no clinical symptoms very low in the present study at 0.17  0.5 days or radiological signs of sinusitis and the implant loading compared to 4.5  3.2 days after the lateral procedure was successful. We can confirm the fithat (unpublished own data). Overall patient satisfaction small membrane perforations are compatible with was 9.87  0.7 points on a VAS from 1 ¼ not satisfied clinically healthy postoperative sinus conditions.
to 10 ¼ very satisfied.
In his systematic review of 10 transcrestal sinus lift Within the limits of a prospective open cohort study studies, Tanidentified a reported mean implant with 20 cases, our data demonstrate the safety and success rate of 92.8%. This is almost the same as for medical efficacy of MISFA using the novel method. A implants placed in the posterior maxilla without graft- height gain of 9.2  1.7 mm could be achieved. In only ing, i.e., 95.9%-Watzerightly remarks one case a membrane perforation occurred without any that the residual local bone height of 6-7 mm usually clinical consequences. The 18-month survival rate was recommended for transcrestal sinus floor elevation 95%. Side effects were acceptable and remarkably means that implants of appropriate length should be lower compared with the lateral approach. Sick leave firmly seated in the host bone. Therefore, at least in the occurrence was very low and overall patient satisfaction first few years, Watzek considers it difficult to say very high. To further evaluate the Jeder-System whether implant stability was achieved because of a broader clinical study (w100 cases) with international transcrestal sinus floor elevation or on account of the study centers is planned in the near future.
bone volume-related short osseointegration segmentsufficient for short implants.
For a residual bone height below the recommended range, the story is different. Without quantifying the effect, confirms the finding of Rosenthat the failure rate of the implants increased with and was correlated to reduced residual bone height. In a multi- center retrospective study, Rosen reported a survival rate of 96%, when the residual bone height was 5 mm or more, but the survival rate decreased to 85.7%, when the residual bone height was 4 mm or less. Watzek 5. Rodrigues GN, Katayama AY, Cardoso RF. Subantral Augmen- rightly remarks that at a residual bone height of tation Utilizing the Zimmer Sinus Lift Balloon Technique. 2010.
<4 mm, implant survival has rarely been reported. In his own recent study with the gel-pressure technique, Accessed March 3, 2013.
Watzereports an implant survival rate 1 year after implant placement of 88.5% at sites with a pre-opera- tive bone height of at least 4 mm (n ¼ 26). This decreases to a 1 year survival rate of 50.0% for sites with a pre-operative bone height of <4 mm (n ¼ 14).
In our study, the survival rate 18 months after implant placement was 94.1% at sites with a pre-operative bone height of at least 4 mm (n ¼ 17) and 100% for sites with a pre-operative bone height of <4 mm (n ¼ 3). Due to the small number of cases with residual bone height of ORAL AND MAXILLOFACIAL SURGERY 300 Jesch et al.
Reprint requests: Emanuel Bruckmoser, MD, DMD Department of Oral and Maxillofacial Surgery ABM University Health Board Morriston Hospital Swansea SA6 6NL, Wales, UK

Source: http://www.sinusafe.co.il/image/users/270045/ftp/my_files/Jeder_article_OOOO_Sep_2013_DB-1.pdf?id=15750355


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