Surgical Technique for alveolar ridge augmentation with maxillary sinus elevation (lateral approach) using a pre-portioned and ready pre-packaged graft composition in gelatin bag and method of producing it

Abstract

The present embodiment relates generally to methods of performing surgical technique maxillary sinus floor augmentation with a lateral approach using a pre-portioned and ready pre-packaged bone graft composition in gelatin bags and method of producing gelatin bags. In addition the present inventions can be widely used in other medical fields such as dentistry, orthopedic surgery, spine surgery, plastic and reconstruction surgery, sport medicine, trauma surgery, phinoplasty surgery and veterinary.

Claims

1. A surgical technique for alveolar ridge augmentation with maxillary sinus elevation (lateral approach) using a pre-portioned and ready pre-packaged bone graft composition in gelatin bag, comprising: a first step of performing a trapezoid incision into soft tissue of gingiva in surgical area to create a trapezoid shaped flap; a second step of retracting back the trapezoid shaped flap of the soft tissue to expose an underlying lateral boney wall of the maxillary sinus; a third step of creating an access to the maxillary sinus, to get access to expose sinus membrane and detaching the sinus membrane from a bone of an inferior surface of a sinus cavity a fourth step applying pre-portioned and ready pre-packaged bone graft composition in gelatin bags into newly created space; a fifth step inserting dental implant through vertical opening; a sixth step suturing the trapezoid shaped flap into the soft tissue;

2. The surgical technique of claim 1, wherein the pre-portioned and ready pre-packaged bone graft composition in the gelatin bag contains bone graft material.

3. The surgical technique of claim 1 wherein-the pre-portioned and ready pre-packaged bone graft composition in the gelatin bag comprises coherent mass bone graft chips harvested from cortical bone.

4. The surgical technique of claim 1 wherein the pre-portioned and ready pre-packaged bone graft composition in the gelatin bag comprises coherent mass bone graft chips harvested from cancellous bone.

5. The surgical technique of claim 1 wherein the pre-portioned and ready pre-packaged bone graft composition in the gelatin bag comprises coherent mass bone graft chips harvested from mix of both cancellous and cortical bone.

6. The surgical technique of claim 1 wherein the pre-portioned and ready pre-packaged bone graft composition is made of a biocompatible mass of bone materials such as autologous or autogenous bone grafting, allogeneic grafts, xenograft and synthetic substitutes.

7. The surgical technique of claim 2 wherein the pre-portioned and ready pre-packaged bone graft composition of, further comprises a sealed saliva-soluble gelatin film bag containing a patient's own body bone graft, or an artificial or synthetic bone graft particles or natural substitutes wherein bone particle sizes have ranged from a mean of 150-400 microns (mu) as a small size to large size up to 1559 mu.

8. The surgical technique of claim 2 wherein the per-portioned and ready pre-packaged bone graft composition of, further comprises a sealed by blood-soluble gelatin film bag containing a patient's own body bone graft, or an artificial or synthetic bone graft particles or natural substitutes wherein bone particle sizes have ranged from a mean of 150-400 microns (mu) as a small size to large size up to 1559 mu.

9. The surgical technique of claim 3 wherein bone graft particles have different sizes and mixture comprising different proportion, weight of small and large sizes of bone particles or mixtures thereof.

10. The surgical technique of claim 3 wherein non-synthetic bone graft chips consist of completely demineralized partially demineralized bone particles or mixtures thereof.

11. The surgical technique of claim 8 wherein the blood-soluble film bag comprises a collagen derivative such as such as collagen or gelatin.

12. The surgical technique of claim 8 wherein blood-soluble film bag comprises a collagen derivative such as such a polysaccharides derivative.

13. The surgical technique of claim 7 wherein the saliva-soluble film bag comprises a collagen derivative such as such a polysaccharides derivative such as starch.

14. The surgical technique of claim 7 wherein the saliva-soluble film bag comprises a collagen derivative such as such a polysaccharides derivative such as glycogen.

15. The surgical technique of claim 7 wherein the saliva-soluble film bag comprises a collagen derivative such as such a polysaccharides derivative such as cellulose.

16. The surgical technique of claim 3 wherein said that the bone graft chips be used in crushed form.

17. A method of producing gelatin bags for coating pre-portioned bone graft which comprises: (a) dosing up an individual dose of bone graft. (b) mixing the individual dose with different types of bone graft materials (c) directly placing bone graft material on a gelatin film. (d) sealing the individual dose of bone graft in gelatin film bags.

18. The method of claim 17 further comprising blending and heating granulated gelatin or any collagen derivatives and other components in heated warm water in a gelatin melting reservoir with correct heat level, mixing and vacuuming, the components form thick mass combination for use in encapsulation process.

19. The method of claim 17 further comprising modeling the bone graft materials by press agglomeration.

20. The method of claim 17 further comprising preparing the individual dose of the bone graft and equipment contains: processing reservoirs, mixers tanks, mills, vacuum homogenizers, and sieves.

21. The method of claim 17 further comprising drying the sealed bag to removes excess humidity and to shrink and stabilize the gelatin bag.

22. The method of claim 18 wherein some other ingredients are added during the melting process such as surfactants, wetting agents, emulsifying agents, or suspending agents.

23. The method of claim 18 wherein comprising adding some other ingredients during the melting process such as surfactants, wetting agents, emulsifying agents, or suspending agents.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0047] FIG. 1 is an intra-operative image: pre-operative surgical site.

[0048] FIG. 2 is a pre-operative cone-beam computed tomography CBCT of the surgical site—axial view.

[0049] FIG. 3 is a pre-operative cone-beam computed tomography CBCT of the surgical site—coronal view.

[0050] FIG. 4 is a pre-operative intraoral radiograph of the patient's surgical site with measurements periapical view.

[0051] FIG. 5 is an intra-operative image: initial incision of mucoperiosteal flap design in surgical site.

[0052] FIG. 6 is an intra-operative image: the lateral wall of maxillary sinus visualized after raising mucoperiosteal flap.

[0053] FIG. 7 is an intra-operative image: osteotomy of the lateral wall of the maxillary sinus.

[0054] FIG. 8 is an intra-operative image: lifted maxillary sinus with implant placed.

[0055] FIG. 9 is an intra-operative image: gelatin film.

[0056] FIG. 10 is an intra-operative image: preparation bone graft composition coated by film from gelatin.

[0057] FIG. 11 is an intra-operative image: gelatin bag with pre-portioned bone graft composition.

[0058] FIG. 12 is an intra-operative image: the placement the gelatin bag with pre-portioned bone graft composition in the maxillary sinus.

[0059] FIG. 13 is an intra-operative image: maxillary sinus cavity access filled with pre-portioned bone graft composition coated by gelatin bags.

[0060] FIG. 14 is an intra-operative image: buccal view after suturing the flap.

[0061] FIG. 15 is a post-operative intraoral radiograph of the patient's surgical site periapical view showing dental implant in the sinus lift area.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0062] Referring to the images now, the present invention describes a dental surgical technique for maxillary sinus lift and dental implant placement that includes using gelatin bag with a pre-portioned bone graft composition.

[0063] In practice, prior to then start of the sinus lift augmentation procedure described above, a current treatment plan must be established based on diagnostic evaluation such as an oral exam, radiographic evaluation from verity radiographs: cone beam computer tomography (CBCT) must be taken to measure the sinus's width and height, panoramic X-ray and full mouth series x-ray is taken to calibrate the patient's upper jaw and maxillary sinuses.

[0064] As demonstrated in FIGS. 1 to 15 a method of surgical technique for alveolar ridge augmentation with maxillary sinus elevation (lateral approach) is shown using a bone graft coated by membrane from gelatin and a method of producing coated bone graft according to present.

[0065] A pre-operative Cone Beam Computed Tomography was performed and used to estimate the efficiency of bone lamina for sinus lifting surgery and bone formation with biomaterials (FIG. 2, 3).

[0066] An additional analysis was performed on periapical radiograph (FIG. 4).

[0067] The procedure is performed from inside the oral cavity of patient's mouth (FIG. 1) where the dental provider makes an incision into soft tissue of gingiva (FIG. 5). Once the trapezoid shape incision is performed, the dental surgeon is retracting back the flap of soft tissue to expose the underlying lateral boney wall of the maxillary sinus (FIG. 6). Then the dentist creates an entry to the maxillary sinus, to get access to the sinus or Schneiderian membrane (FIG. 7). The sinus membrane is detached from the bone of the inferior surface of the sinus cavity and the newly formed space within the bony cavity of the maxillary sinus is grafted with pre-portioned and ready pre-packaged bone graft composition in gelatin bags (FIGS. 9-12) to provide sufficient space to place dental implants into the surgical site (FIGS. 8, 13, 15). A root form implant (AB-implant, 4.2×10 mm) was placed and the gums are then sutured close (FIG. 14).

Example

[0068] The surgical procedure discussed in this case was performed at Privet Dental Office in Los Angeles, Calif., USA.

[0069] A 49-year-old Caucasian female, with a good health status (ASA score: 0), was attended to at the dental office; written informed consent was obtained from the patient to have the case details. Patient was informed regarding the use of a new approach in sinus lift augmentation surgery. She was indicated for a prosthetic implant rehabilitation procedure in the upper right quadrant after a maxillary sinus lift procedure for atrophy of the maxillary bone at the first molar level to install one dental implant.

[0070] A pre-operative evaluation of the patient's maxillary sinus for implant planning was performed using CBCT images before surgery,

[0071] The surgery was performed under antibiotic prophylaxis: Amoxicillin 2 gr 1 hour before the surgery. For the local anesthesia (4% Septocaine with 1/100,000 epinephrine 1.7 ml 2 cartridges) were administrated in buccal and palatal areas around the tooth. The patient was placed on systemic antibiotics for seven day: Amoxicillin 500 mg (1 capsule every 8 hours).

[0072] A full-thickness flap (FIG. 5) was lifted (FIG. 6) via trapezoid shape incision. In the meantime, the receiving site was prepared according to the standard surgical protocol used for lateral sinus floor augmentation (FIG. 7). The wall osteotomy was performed using a slow speed handpiece with a surgical round bur and the window elevation was performed and exposed the underlying Schneiderian membrane (FIG. 8).

[0073] Through delicate instrumentation, the sinus membrane was carefully reflected and peeled from the inner surface of the sinus cavity wall (FIG. 8).

[0074] A particular mass of bone graft chips can be harvested from different parts of patient jaw or harvested from an individual other than the receiving patient or bone substitutes had its origin from a species other than human or synthetic bone particles.

[0075] At the same time the process to prepare pre-portioned and ready pre-packaged biocompatible osteogenic bone graft composition is started, creating the single dose in the bags of blood-soluble gelatin film (FIGS. 9, 10, 11).

[0076] The mass of bone graft consist of a different variety of sizes of bone chips.

[0077] The coherent mass of bone graft chips can harvest from cortical, cancellous or mix of both types of bone.

[0078] The bone graft was positioned in the newly formed subantral cavity to preserve the sinus membrane, and the space was then filled with the single doses in the bags of blood-soluble and saliva-soluble gelatin film (FIG. 12).

[0079] The maxillary sinus entry was packed with gelatin bags (FIG. 13) and the flap was sutured with a 4-0 silk suture and removed ten days post the surgery. (FIG. 14)

[0080] A regular size of root form implant (having a 4.2 mm in diameter size and length of 10 mm) was placed (FIG. 15).

[0081] The soft tissue around the dental implant healed good with minimal discomfort for patient.

[0082] The importance of continuing a high standard of oral hygiene was addressed to the patient.

[0083] Tooth brushing and flossing techniques were reinforced.

[0084] During the postoperative period, the patient received antibiotic therapy (Amoxillin 500 mg (1 tablet every 8 hours for 7 days) and performed oral rinses with 0.2% Chlorhexidine (Peridex, 0.12%) was prescribed for three times/day for 10 days. (Azizi B, Budimir A, Mehmeti B, Jakovljevid S, Bago I, Gjorgievska E, Gabrio D., “Antimicrobial Efficacy of Photodynamic Therapy and Light-Activated Disinfection Against Bacterial Species on Titanium Dental Implants.” Int J Oral Maxillofac Implants. 2018 July/August; 33(4):831-837—incorporated herein by reference).

[0085] The prognosis of current surgical procedure was highly favorable. The patient received full explanation regarding long-term prognosis and oral hygiene maintenance. During the time of follow-up no hard and soft tissue changes was detected.

[0086] Delayed dental implant placement and delayed loading was planned to allow continue chewing function of the patient.

[0087] The surgical technique described in this article developed new approach of alveolar ridge augmentation with maxillary sinus elevation (lateral approach) using a pre-portioned and ready pre-packaged bone graft composition in gelatin bags.

[0088] This method eliminates the several commonly found complications such as sinus or Schneiderian membrane perforation, bone graft exposure, postoperative incidences of dislodgement of the bone graft, loss of bone graft and difficulties during manipulation with bone grafting.

[0089] Method that can be used to enhance the stability of bone graft for instance, to tightly pack of the graft particles.

[0090] Thereby, the above-mentioned discussion discloses and describes simply exemplary embodiments of the present inventions. As doctors will understand, the present inventions can be implemented in other specific forms without changing the main idea of current innovations. Respectively, the disclosure of the present embodiment is planned to be illustrated, but not limiting of the capability of the inventions, as well as other claims.