Gel-Pressure Technique for Flapless Transcrestal ...

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floor via surgical templates using gel pressure. Materials ... Email: [email protected]. © 2009 BY QUINTESSENCE ... maxillary sinus floor elevation via surgical templates ... to a dental laboratory, and a custom surgical tem-.
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Gel-Pressure Technique for Flapless Transcrestal Maxillary Sinus Floor Elevation: A Preliminary Cadaveric Study of a New Surgical Technique Bernhard Pommer, DDS1/Georg Watzek, MD, DDS2 Purpose: To evaluate a novel surgical technique for flapless transcrestal elevation of the maxillary sinus floor via surgical templates using gel pressure. Materials and Methods: Computed tomographic scans of fresh human cadaver maxillae and three-dimensional treatment planning software were used to design surgical templates. Access to the maxillary sinus was gained by guided transcrestal osteotomies to puncture the bony sinus floor. By injection of radiopaque gel, the maxillary sinus membrane was elevated to attain a postoperative bone height of 15 mm. Results: The gel-pressure technique was performed in 10 atrophic maxillary sites with a mean residual bone height of the alveolar crest of 4.7 ± 1.6 mm. The sinus membrane was successfully elevated in all sites without causing iatrogenic perforation (mean elevation height, 10.6 ± 1.6 mm). Conclusions: The gel-pressure technique may provide a new option for minimally invasive transcrestal sinus surgery and may represent a safe method to increase bone volume in the atrophic posterior maxilla. INT J ORAL MAXILLOFAC IMPLANTS 2009;24:817–822 Key words: bone augmentation, dental implants, maxillary sinus, minimally invasive surgery, surgical templates

lveolar bone resorption and pneumatization of the maxillary sinus reduce the available amount of bone for the placement of dental implants in the edentulous posterior maxilla.1,2 Techniques for internal bone augmentation of the maxillary sinus floor have been established to overcome this anatomical limitation. 3,4 The formation of vital bone to allow osseointegration of implants (whether placed at the time of sinus augmentation or later) is initiated by apical displacement of the maxillary sinus membrane (maxillary sinus mucosa) with or without the addition of bone (or bone substitute) material.5 Elevation of the sinus membrane is accomplished via either a lateral6 or a transcrestal7 approach to the antrum. The transcrestal approach to the maxillary sinus is advocated as

A

1Assistant

Professor, Department of Oral Surgery, Bernhard Gottlieb School of Dentistry, Medical University of Vienna, Austria. 2Professor, Department Head, and Medical Director, Department of Oral Surgery, Bernhard Gottlieb School of Dentistry, Medical University of Vienna, Austria. Correspondence to: Dr Bernhard Pommer, Bernhard Gottlieb School of Dentistry, Department of Oral Surgery, Waehringerstr. 25a, A-1090 Vienna, Austria. Fax: +43-1-4277-67019. Email: [email protected]

“minimally invasive” because of the undisturbed vascularization of the graft and reduced postoperative morbidity.8 An important question concerning minimally invasive sinus augmentation is whether the obtainable amount of bone height is generally limited with the minimally invasive approach9,10 and therefore a conventional lateral approach should be preferred in patients with severely resorbed maxillae. 11 The increase in bone height obtainable by osteotomemediated transcrestal techniques has been shown to be inferior to that obtainable by the conventional lateral approach.5 Another great concern in transcrestal sinus floor elevation techniques is the avoidance of iatrogenic sinus membrane perforation, as the elevation of the sinus membrane is not performed under optical or tactile control. 12 Because of the limited access, there is no possibility to repair the torn membrane without changing to a lateral surgical approach.11 Various modifications to the transcrestal osteotome-mediated sinus floor elevation technique have been reported in the literature: membrane elevation by inflation of a balloon catheter13,14 and the use of hydraulic pressure15–17 or negative pressure.18 The gel-pressure technique (GPT) for flapless transcrestal The International Journal of Oral & Maxillofacial Implants 817

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Fig 1a (Left) Presurgical three-dimensional planning procedure. Fig 1b (Right) Measured distance x between the top edge of the planned implant and the bony sinus floor in the cross-sectional CT scan.

x

9 mm

maxillary sinus floor elevation via surgical templates was developed by Watzek. The present study details this new method for separating and elevating the sinus membrane from the bony sinus floor for the purpose of bone grafting and simultaneous implant placement. The aim of this preliminary cadaveric study was to evaluate the incidence of sinus membrane perforations and to quantify the gain in height of implant sites by GPT.

MATERIALS AND METHODS Preoperative Workup Edentulous maxillae of four fresh human cadavers (two male and two female specimens with a mean age of 73 years) were obtained from the Institute of Anatomy at Vienna Medical University, Austria. No formaldehyde fixation was carried out to avoid alteration in tissue consistency.19 Immediately after preoperative computed tomographic (CT) scanning, the maxillae were deep-frozen to –20°C until just prior to the surgery. Double-scan–technique CT scans were acquired with a conventional CT scanner (Tomoscan SR-6000, Philips) using a standard dental CT investigation protocol (1.5-mm slice thickness, 1.0-mm table feed, 120 kV, 75 mA, 2-s scan time, 100- to 120-mm field of view, high-resolution bone filter). 20 Six radiopaque markers (gutta-percha balls) were placed into a polyvinyl siloxane impression of each edentulous jaw to perform the double-scan technique21,22: the first scan was of the maxilla and the planning template in situ, the second of the planning template only. Computer-assisted treatment planning software (Nobel Biocare)23 allowed superimposition of the two sets of scans onto each other and three-dimensional

planning of the site of sinus trephination and implant position (Fig 1a). The planning data were transferred to a dental laboratory, and a custom surgical template with precision titanium tubes was fabricated. The depth of the planned osteotomy was determined precisely via cross-sectional images of the elevation site (Fig 1b) to facilitate puncture of the bony sinus floor without perforation of the adherent sinus membrane. The distance between the top edge of the planned implant and the bony sinus floor (x) was measured in the center of the implant. The planned drilling depth was calculated by adding 10 mm to this value (9 mm distance between the top edge of the planned implant and the top edge of the titanium tube, plus 1 mm height of the drill guide).

Surgical Technique The surgical template was checked for proper seating and secured in place by three horizontal stabilization pins. A soft tissue punch of 4.1 mm in diameter was used at the planned elevation site without mucoperiosteal flap retraction. Cannon drills of 3.3 mm in diameter with internal irrigation (Friadent)24 were used for transcrestal osteotomies to puncture the bony floor of the sinus. Because of its rounded tip, this type of drill was considered more capable of preventing sinus membrane perforation than pointed drills. Custom-made drill depth stops were applied to reduce the length of the Cannon drill to the preplanned drilling depth (Fig 2a). If no bony opening was created in the sinus floor by the first osteotomy, the drilling depth was increased by 0.5 mm (ie, the height of the drill depth stop was decreased by 0.5 mm) until the bony sinus floor was punctured successfully. The integrity of the sinus mucosa was then evaluated by direct visual examination through the

818 Volume 24, Number 5, 2009 © 2009 BY QUINTESSENCE PUBLISHING CO, INC. PRINTING OF THIS DOCUMENT IS RESTRICTED TO PERSONAL USE ONLY. NO PART OF THIS ARTICLE MAY BE REPRODUCED OR TRANSMITTED IN ANY FORM WITHOUT WRITTEN PERMISSION FROM THE PUBLISHER.

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Fig 2 Procedure schematics. (Left) Guided transcrestal osteotomy. (Right) Gel injection. 1 = surgical template; 2 = drill guide; 3 = drill depth stop; 4 = Cannon drill with internal irrigation; 5 = injection nozzle; 6 = silicon seal ring; 7 = screw nut; 8 = radiopaque gel; 9 = schneiderian membrane; 10 = maxillary sinus.

10

10

9

9 8

6

4

5 1

1

2

2

3

3

7

4

5

removed orbital floor. Next, a specially designed injection nozzle was inserted into the osteotomy and positioned 1 mm caudal to the sinus floor (Fig 2b). A silicon sealing ring at the tip of the nozzle was compressed by rotation of a screw nut to tightly close the osteotomy and secure the nozzle in place. Under controlled pressure, a radiopaque gel was administered through the injection nozzle to separate and elevate the sinus membrane from the bony sinus floor until a total postoperative alveolar height of at least 15 mm was attained. Pressure control was achieved by a mechanical device attached to the injection nozzle designed to limit the applied pressure to a maximum of 1 bar (0.1 MPa) in all elevated sites. The injected gel consisted of hydroxy-propylmethylcellulose (HPMC) 2% (viscoelastic agent) and jopamidol 37% (radiopaque marker) in a mixing ratio of 3:1. HPMC is a high-molecular-weight, water-soluble polymer that is used in ophthalmic cataract surgery25 and offers advantages including the gentle creation or maintenance of surgical spaces and protection of tissues.26 A 2% HPMC solution is easy to wash out 27 and even when left behind does not cause significant inflammation and is undetectable after 3 days.28–30 Jopamidol is used as an intravenous and gastrointestinal contrast agent and does not produce any inflammatory tissue reaction.31 Thus, in contrast to bone graft paste, the presented gel mixture can be safely used for sinus membrane elevation, as no foreign body reaction would be expected in cases of membrane perforation or incomplete removal. In a clinical setting, the integrity of the sinus membrane can be evaluated by inspecting the containment of the contrast agent via intraoperative radiographs before the gel is washed out and the graft material, as well as the implant, are placed.

Statistical Methods Preoperative residual bone height, height of membrane elevation, and total postoperative height were assessed on postoperative CT scans, and the volume of gel injected was recorded. Mean values and standard deviations were calculated. The integrity of the sinus membrane was evaluated by direct visual examination through the removed orbital floor and on the postoperative CT scans. The Pearson correlation coefficient32 was used to test the following variables for linear relationships: Preoperative residual bone height versus total postoperative height, preplanned drilling depth versus actual drilling depth, and height of membrane elevation versus gel volume injected. All calculations were done using R-project software (R Foundation for Statistical Computing).

RESULTS Ten flapless transcrestal sinus floor elevations were performed in eight maxillary sinuses of four cadaver maxillae. The mean residual bone height of the alveolar crest was 4.7 ± 1.6 mm (range, 2.4 to 7.5 mm) at the elevation site (Table 1). Seating of the surgical template was satisfactory in all cases. To successfully puncture the bony floor of the maxillary sinus, the planned drilling depth had to be increased by 0.5 mm in one site and by 1.0 mm in three sites. In the majority of sites (60%) the planned drilling depth equaled the actual drilling depth, showing a high statistical correlation (r = 0.966). The bony opening created in the sinus floor was smaller than the diameter of the drill, and no perforations of the sinus membrane occurred during the drilling procedure. The International Journal of Oral & Maxillofacial Implants 819

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Table 1 Sinus Membrane Elevation by GPT in Four Maxillae Sample/site

Residual bone Elevation Total postop Gel height (mm) height (mm) height (mm) volume (mL)

1 R first molar L first molar 2 R first molar L second premolar L first molar L second molar 3 R first molar L second premolar 4 R first molar L first molar Mean ± SD

Membrane perforation

2.4 6.9

12.6 8.4

15.0 15.3

3.1 1.1

No No

4.6 6.2 4.4 3.9

10.6 8.6 10.7 11.4

15.2 14.8 15.1 15.3

2.1 2.0 2.1 2.3

No No No No

7.5 2.8

8.0 12.1

15.5 14.9

0.9 2.8

No No

4.5 3.3 4.7 ± 1.6

11.2 11.9 10.6 ± 1.6

15.7 15.2 15.2 ± 0.3

2.2 2.7 2.1 ± 0.7

No No 0%

Figs 3a and 3b GPT membrane elevation in sinuses (left) without and (right) with sinus septa observed through the removed orbital floor. Arrow indicates the transcrestal osteotomy; asterisks indicate the buccodistal direction.

*

* Figs 3c and 3d Postoperative (left) axial and (right) cross-sectional CT scans. Arrow indicates the transcrestal osteotomy; asterisks indicate the buccodistal direction.

*

*

The mean volume of gel injected was 2.1 ± 0.7 mL (range, 0.9 to 3.1 mL). The mean height of membrane elevation was 10.6 ± 1.6 mm (range, 8.0 to 12.6 mm). A strong statistical correlation between gel volume and height of elevation was observed (r = 0.929). Progressive gel injection resulted in circular, centrifugal dissection of the sinus membrane and the formation of a dome-shaped subantral space (Fig 3a). In the left sinus of maxilla no. 2, which was divided into three recesses by two buccopalatal septa, each recess was successfully elevated without demonstrating a higher risk of membrane perforation (Fig 3b). The mean total

height after membrane elevation amounted to 15.2 ± 0.3 mm (range, 14.8 to 15.7 mm). No statistical correlation between the residual bone height of the alveolar crest and the total postoperative height of the subantral space was found (r = 0.320). In all tested sites, elevation was adequate to accommodate an implant of at least 13 mm in length. No perforation of the sinus mucosa could be observed, either by direct visual examination through the removed orbital floor or radiographically in postoperative CT scans (Figs 3c and 3d).

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*

*

Fig 4 Clinical treatment using the GPT. (Left) Presurgical planning; (center) cross-sectional CT scan 6 months after transcrestal sinus floor elevation and implant insertion (asterisks indicate the buccal direction). (Right) Intraoperative radiograph indicating sinus membrane integrity.

DISCUSSION Surgical techniques are of particular importance in increasing the success rates for dental implants in the posterior maxilla.11 The present study describes a new technique that uses gel pressure to elevate the maxillary sinus membrane for bone grafting between the bony sinus floor and the sinus membrane and simultaneous placement of endosseous implants using surgical templates. The method was modeled experimentally in fresh human cadaver maxillae. Intermediate freezing of the maxillae was necessary to preserve the cadaver tissues during the time required for fabrication of the surgical templates. Artefactual effects caused by temperature alteration might be suspected in collagenous tissues. Studies have revealed that relatively little protein denaturation occurs at –20°C,33 and cold denaturation of proteins is usually reversible in nature.34 No alteration in cell morphology after tissue sample storage was found with phase-contrast and dark-field light microscopy.35 It may therefore be concluded that the surgical characteristics of the cadaver tissues had not been altered significantly from the typical clinical situation. The main advantage of the GPT is the smooth transfer of force required for elevation of the maxillary sinus membrane from the bone underneath. Compared to osteotome-mediated techniques, in which elevation forces are transferred to the sinus membrane via point transmission,11 the GPT allows for a larger area of force transmission. By these means, point forces that might exceed the elastic proper ties of the schneiderian membrane are avoided. Sudden pressure that can cause sinus membrane perforation16 is absorbed by the cushioning effect of the highly viscous HPMC (4.5 MPa). In the course of transcrestal sinus membrane elevation, the force required for further membrane detachment increases along with the circumference of the created subantral space. Membrane perforation can occur as

soon as elevation forces exceed the load limits of the sinus membrane. Because of the optimized force transmission, the height of membrane elevation obtainable with the GPT may be superior to that obtainable with osteotome-mediated techniques. The GPT represents a flapless transcrestal procedure that avoids exposure or removal of the lateral wall of the sinus. Advantages of the keyhole approach to the sinus include less alveolar resorption, better vascularization of the graft,10 minimal bleeding, less postoperative discomfort, and high patient acceptance. There is no intrinsic limitation of the technique if the initial bone height is severely reduced and secondary implant placement is required. In cases of maxillary septa, multiple transcrestal approaches can be chosen.36 The GPT combines the advantages of the lateral window approach, which permits the placement of high volumes of bone grafts or bone substitutes, and the minimally invasive transcrestal approach. A long-term prospective clinical study is currently underway at the Department of Oral Surgery, Bernhard Gottlieb School of Dentistry, Medical University of Vienna, Austria, to investigate graft and implant success rates as well as perioperative and postoperative morbidity of the GPT in an in vivo clinical setting. The treatment of a 33-year-old man with the GPT is presented in Fig 4. Intraoperative and postoperative radiographic images revealed no perforation of the maxillary sinus membrane and successful bone augmentation achieved by the GPT.

CONCLUSIONS Within the limits of a preliminary cadaveric study, it appears that the gel-pressure technique may be a practical method to correct alveolar deficiencies in the edentulous posterior maxilla. The height of sinus membrane elevation was not found to be limited, and perforation of the sinus membrane during elevation The International Journal of Oral & Maxillofacial Implants 821

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could be avoided. The results of the present study would suggest that this new surgical technique may reduce patient morbidity and extend the indications for transcrestal maxillary sinus floor elevation.

ACKNOWLEDGMENTS The authors gratefully acknowledge the contributions of Univ Prof Dr Helmut Gruber at the Institute of Anatomy (Medical University of Vienna) for providing cadavers and Ing Ewald Unger at the Center for Biomedical Engineering and Physics (Medical University of Vienna) for fabrication of the custom-made parts of the apparatus.

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