™ Clinical Cases Minimally invasive sinus lift procedures with the iRaise™ Sinus Lift Implant Uplifting Implant Dentistry TABLE OF CONTENTS MINIMALLY INVASIVE SINUS LIFT AND SINGLE-UNIT RESTORATION WITH iRaise™ Dr. Dragos Slavescu, DDS, DMD, PhD, Specialist In Oral and Maxillofacial Surgery, Bucharest 4 MINIMALLY INVASIVE SINUS LIFT WITH iRaise™ USING A SURGICAL STENT Surgery: Dr. Hadar Better, MD, DMD, MSc, Specialist In Oral and Maxillofacial Surgery, Tel Aviv Prosthodontics: Dr. Yuval Wind, R.E Goldstein Center For Aesthetic Dentistry & Clinical Research, Prosthodontics Department, Faculty Of Dentistry, Hebrew University-Hadassah, Jerusalem 6 MINIMALLY INVASIVE SINUS LIFT AND TWO-UNIT RESTORATION WITH iRaise™ Dr. Dragos Slavescu, DDS, DMD, PhD, Specialist In Oral and Maxillofacial Surgery, Bucharest 8 MINIMALLY INVASIVE SINUS LIFT AND TWO-UNIT RESTORATION WITH iRaise™ Surgery: Dr. Hadar Better, MD, DMD, MSc, Specialist In Oral And Maxillofacial Surgery, Tel Aviv Prosthodontics: Dr. Eran Dolev, Tel Aviv 10 MINIMALLY INVASIVE SINUS LIFT WITH iRaise™ IN CASE WITH MAXILLARY SEPTUM Surgery: Prof. Gabriel Chaushu, DMD, MSc, Specialist In Oral and Maxillofacial Surgery, Director, Department Of Oral and Maxillofacial Surgery, Rabin Medical Center Prosthodontics: Dr. Doron Haim, DMD, MPH, Director, Center For Dental Health and Implantology, Assaf Harofeh Medical Center 12 BILATERAL MINIMALLY INVASIVE SINUS LIFTS WITH iRaise™ Surgery: Dr. Hadar Better, MD, DMD, MSc, Specialist In Oral and Maxillofacial Surgery, Tel Aviv Prosthodontics: Dr. Tirza Ramon, DMD, MPH, Specialist In Public Health Dentistry, Tel Aviv 14 Maxillent Ltd. Proprietary Information | 3 Minimally Invasive Sinus Lift And Single-Unit Restoration with iRaise™ Dr. Dragos Slavescu, DDS, DMD, PhD, Specialist in Oral and Maxillofacial Surgery, Bucharest A 61 year old female, with no prior medical history, presented with a missing first upper left molar. Due to insufficient residual height of the alveolar ridge (4.5 mm), a sinus lift was indicated. Pre-operative Examination Treatment plan: Simultaneous sinus lift and implantation with iRaise™ Sinus Lift Implant, 4.2 mm diameter, 14 mm length Panoramic X-ray showing missing upper left first molar, with 4.5 mm of residual alveolar bone height Surgery Saline injection and retrieval through the iRaise™ Bone graft injection Follow-up Treatment Healing cap in place following second stage surgery at 8 months 4 Final restoration at 19 months post-op Post-operative periapical X-ray showing iRaise™ fully inserted Follow-up X-rays Periapical X-ray at 7 months Panoramic X-ray at 13 months CT Images Pre-op CT with implant site marked by yellow outline (top), and at 19 months (bottom) Clinical Notes •• The iRaise™ procedure and subsequent restoration were uneventful. •• This case presented a single-tooth gap between adjacent teeth, and the iRaise™ instrumentation was successfully introduced and operated between them. •• The post-healing CT indicates significant generation of new bone around the implants. Maxillent Ltd. Proprietary Information | 5 Minimally Invasive Sinus Lift With iRaise™ Using A Surgical Stent Surgery: Dr. Hadar Better, MD, DMD, MSc, Specialist in Oral and Maxillofacial Surgery Prosthodontics: Dr. Yuval Wind, R.E Goldstein Center for Aesthetic Dentistry & Clinical Research, Prosthodontics Department, faculty of Dentistry, Hebrew University-Hadassah, Jerusalem A 48 year old male presented with missing first and second upper right molars, requiring a sinus lift in order to place implants (5.5 mm residual bone height). The patient had no prior medical history. Pre-operative CT Treatment Plan A simultaneous, minimally invasive sinus lift procedure and dental implantation with an iRaise™ Sinus Lift Implant, 4.2 mm diameter, 17 mm length, and one additional standard implant. The prosthodontist prepared a surgical stent to indicate the preferred location of both implants. Surgery Initial view Surgical stent Final Restoration Final restoration at 10 months 6 Saline injection and retrieval X-rays Periapical radiographs: intra-operative with depth guide (top), immediately post-op with two implants (middle), and with PFM try-ins at 9 months (bottom) Clinical Notes •• The iRaise™ procedure and follow up were uneventful. •• The appearance of blood in the returning saline was found to be a useful clinical marker, indicating that the Schneiderian membrane was accessed by the saline injection. •• The surgical stent was successfully used in conjunction with the iRaise™ and facilitated an optimal implant location in accordance with the restorative plan. Maxillent Ltd. Proprietary Information | 7 Minimally Invasive Sinus Lift And Two-Unit Restoration With iRaise™ Dr. Dragos Slavescu, DDS, DMD, PhD, Specialist in Oral and Maxillofacial Surgery, Bucharest A 42 year old male, with no prior medical history, presented with missing first and second upper right molars. Residual height of the alveolar ridge was 6 mm, necessitating a sinus augmentation procedure. Pre-operative Panoramic X-ray (before initial preparation) Treatment plan: Simultaneous sinus lift and implantation with iRaise™ Sinus Lift Implant, 4.2 mm diameter, 17 mm length, and an additional, standard dental implant, 4.2 mm diameter, 14 mm length Surgery iRaise View after initial preparation iRaise™ insertion Follow-up Treatment Healing caps in place at 8 months 8 Final restoration at 16 months Post-operative periapical X-ray with iRaise™ and additional implant Panoramic X-ray at 24 months iRaise CT at 24 months iRaise™ location is marked by yellow outline Clinical Notes •• The iRaise™ procedure and clinical follow up were uneventful. •• A post-operative CT indicated significant bone formation around the implants, including several millimeters apically. Maxillent Ltd. Proprietary Information | 9 Minimally Invasive Sinus Lift And Two-Unit Restoration With iRaise™ Surgery: Dr. Hadar Better, MD, DMD, MSc, Specialist in Oral and Maxillofacial Surgery, Tel Aviv Prosthodontics: Dr. Eran Dolev, Tel Aviv A 63 year old male, with no prior medical history, presented with missing second upper left premolar and first upper left molar. Residual height of the alveolar ridge was 5.5 mm, necessitating a sinus augmentation procedure. Pre-operative CT Treatment plan: Simultaneous sinus lift and implantation with iRaise™ Sinus Lift Implant, 4.2 mm diameter, 17 mm length, and an additional standard dental implant (4.2 mm diameter, 13 mm length) 10 Surgery iRaise Initial view (temporary bridge removed) Saline injection through partially inserted iRaise™ Post-operative periapical X-ray with iRaise™ and additional implant Follow-up Treatment Healing caps in place at 10 months Final restoration at 14 months post-op Follow-up X-ray at 10 months iRaise Healing caps in place at 10 months Clinical Notes •• The iRaise™ procedure and follow up were uneventful. •• The patient resumed an extremely active lifestyle on the day of the iRaise™ procedure. Maxillent Ltd. Proprietary Information | 11 Minimally Invasive Sinus Lift With iRaise™ In Case With Maxillary Septum Surgery: Prof. Gabriel Chaushu, DMD, MSc, Specialist in Oral and Maxillofacial Surgery, Director, Department of Oral and Maxillofacial Surgery, Rabin Medical Center Prosthodontics: Dr. Doron Haim, DMD, MPH, Director, Center for Dental Health and Implantology, Assaf Harofeh Medical Center A 51 year old female, with no prior medical history, presented with missing upper left first and second molars. Residual alveolar bone height of 5 mm indicated a sinus lift. However, a large septum in the maxillary sinus complicated the treatment plan in case of a standard open sinus lift. Pre-operative CT Treatment plan: Simultaneous sinus lift and implantation with iRaise™ Sinus Lift Implant, 4.2 mm diameter, 17 mm, mesially located with respect to the septum; additional standard implant (4.2 mm diameter, 13 mm length), distally located with respect to the septum Surgery Septum iRaise Saline injection through partially inserted iRaise™ 12 Bone graft injection through iRaise™ Immediate post-op periapical X-ray. Septum is visible between implants Follow-up Treatment Healing caps in place at 9 months Final restoration Follow-up Panoramic X-ray at 9 months iRaise L Clinical Notes •• The iRaise™ procedure and follow up were uneventful. •• The septum did not present any difficulty with the procedure. The membrane was raised hydraulically without event. •• The elevation was initiated mesially to the septum and proceeded distally beyond the septum. •• In this case a synthetic bone graft was used (MBCP™ Gel by Biomatlante). Its increased radio-opacity, relative to allografts that were previously used, granted improved imaging of the bone graft in immediate post-operative radiographs. Maxillent Ltd. Proprietary Information | 13 Bilateral Minimally Invasive Sinus Lifts With iRaise™ Surgery: Dr. Hadar Better, MD, DMD, MSc, Specialist in Oral and Maxillofacial Surgery Prosthodontics: Dr. Tirza Ramon, DMD, MPH, Specialist In Public Health Dentistry, Tel Aviv A 56 year old female, with no prior medical history, presented with multiple missing upper teeth bilaterally, and an indication for bilateral sinus lifts (residual alveolar heights of 5.5 mm and 4.5 mm on the right and left sides, respectively). Pre-Operative CT Treatment Plan Treatment performed in two separate sessions. The left side treated first with an iRaise™ Sinus Lift Implant, 4.2 mm diameter, 17 mm length and two additional standard implants. The right side treated with an iRaise™ Sinus Lift Implant of 4.2 mm diameter, 17 mm length, and one additional standard implant. Surgery Left side: bone graft injection Right side: tube connector 14 Left side after bone graft injection (bone graft visible in opening) Right side: bone graft injection Left side: Three implants in place Right side: Two implants in place Follow-up Treatment – Left Side Healing caps in place at 9 months Temporary restoration at 10 months Periapical X-rays Right side, immediately post-op Left side at six months Panoramic X-rays iRaise iRaise Panoramic X-ray immediately after the second procedure (right side), 10 months after the first procedure. Clinical Notes •• Both iRaise™ procedures and follow up were uneventful. •• The patient was highly satisfied with the result on the left side and eager to perform the second procedure on the right. Maxillent Ltd. Proprietary Information | 15 Company Profile Maxillent’s development and manufacturing facilities are certified for ISO 13485, and all the company’s products are CE-Mark approved. FDA approval is currently in process. Maxillent’s uncompromising commitment to quality and strict adherence to regulatory guidelines ensures that it not only meets, but exceeds the industry’s most stringent quality standards. Maxillent’s technology is based on proprietary R&D, with a rich intellectual property portfolio. Maxillent products are covered by US patents 7934929, 8029284, and additional US and international patents pending. The following trademarks are owned by Maxillent: Maxillent™, iRaise™, and iSure™. Contact Information: Maxillent Ltd. , 85 Medinat Hayehudim St., POB 4100 , Herzliya 46140 ISRAEL T +972-9-953-4500 | F +972-9-953-4501 e-mail: [email protected] website: www.maxillent.com 0344 MKCS10001 Maxillent Ltd. provides innovative solutions that are transforming the field of dental implants. The company’s flagship product is iRaise™, the Sinus Lift Implant, which allows dental professionals to perform a minimally invasive sinus floor elevation and implantation in a single, simple procedure. In addition to the iRaise™, Maxillent offers a comprehensive range of iSure™ dental implants, prosthetics, bone graft materials and tools that cover the entire spectrum of dental implant procedures.
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