Table of Contents

Graham Blackbeard, Founder and Managing Director

Graham Blackbeard,
Founder and Managing Director

Message from Graham

Welcome to the January issue of “Southern Implants In Focus

 

First and foremost, I am taking this opportunity to thank our customers, colleagues and friends for the loyalty and support you have shown throughout the exceptionally challenging year of 2020. We value you and are here to continue to support you in every way we can.

 

In spite of the challenges the COVID-19 Pandemic has brought our industry, for Southern, 2020 was a year of substantial improvements and progress in our drive to comply with the new European MDR regulation, expanding to new markets and focusing on new product developments. All of this was only possible due to the dedication of each and every team member, and the core values in which we share. I am grateful to be surrounded by such an exceptional group of people.

Our motto throughout 2020 was to use the opportunity that this crisis has created, to move things forward. The result was that while many of our competitors were retrenching in Q3 & Q4, we employed 8 new staff members at our headquarters in Irene, South Africa and an additional 4 in our most rapidly growing markets.

Restructuring, expanding to new markets and product development will be our focus for 2021. As for our accomplishments in 2020, we can’t wait to release these new developments to you in the coming months.

Until then, our wish for you is that 2021 will be a year of growth and fulfilment, together with an abundance of prosperity and health.

 

Finally, let us remember the words of Winston Churchill “Success is not Final, Failure is not Fatal: It is the courage to continue that counts.”

Southern Implants Zygomatic implants - 20 years in the making

PROVATA® – A Case Report with Three-Year Follow-Up

P.O. Östman, DDS, PhD, MD

Overview

The PROVATA Implant is the combination of two proven designs: Southern Implants’ external hex body with an internal hex connection. The same implant body shape and thread as the external hex allows the same surgical kit and site preparation sequence. The PROVATA Implant internal hex connection is precision-machined for maximum stability and implant-abutment sealing, as well as providing excellent tactile sensibility during placement and connection of prosthetic parts.

The PROVATA Implant range is made up of PRO (available in Ø4 and 5mm diameters) and PROMAX® (available in Ø6, 7, 8 and 9mm diameters).

Regardless of implant diameter, PROVATA Implants have one of two prosthetic connection sizes: standard or wide. This reduces clinician inventory requirements and ensures compatibility with a variety of existing tooling.

PROVATA has a tapered body shape with a rounded implant apex to mitigate risk of harm to anatomical structures. The range is manufactured from high strength Grade 4 Titanium (≥ 900 MPa).

Surgical and Prosthetic Benefits

  • Reduced inventory requirements.
  • Excellent tactile sensibility during placement of prosthetic components.
  • SInergy Surface – Southern Implants has used the same alumina-blasted surface for over 20 years, with successful clinical results in both early osseointegration and longevity.1, 2
  • A smooth machined beveled implant collar, which provides a built-in platform shift.
  • PRO Implants available with MSc design for high-risk patients (i.e. an extended smooth machined surface over the top crestal 3mm of the implant).
  • Rounded implant apex, which mitigates risk of harm to anatomical structures.
  • Wide range of prosthetic options for treatment of single tooth, partial or full-arch rehabilitation in standard and digital designs.

1Vandeweghe, S., Ferreira, D., Vermeersch, L., Mariën, M., & De Bruyn, H. (2016). Long‐term retrospective follow‐up of turned and moderately rough implants in the edentulous jaw. Clinical oral implants research, 27(4), 421-426.

2 Vandeweghe, S., Hawker, P., & De Bruyn, H. (2016). An Up to 12‐Year Retrospective Follow‐Up on Immediately Loaded, Surface‐Modified Implants in the Edentulous Mandible. Clinical implant dentistry and related research, 18(2), 323-331.

Preoperative Clinical Photograph

Preoperative Clinical Photograph

Preoperative Radiograph

Preoperative Radiograph

Failed maxillary front

Clinical Case Overview:

Patient Age/Gender: 50-year-old female
Chief Complaint: Failed maxillary incisors and lateral due to trauma. Request fixed solution.
Radiographic Findings: Sufficient bone volume for a fixed implant-supported prosthesis. No apical lesion. Loss of bone more than half the root length.
Clinical Findings: Mobile front Grade III. PPD 5-7 mm. Biotype 2. Acceptable oral hygiene
Diagnosis: Periodontitis gravis due to trauma
Treatment Plan: Extraction of centrals and laterals, implant installation with temporary prosthesis, healing 12 weeks and thereafter definitive prosthetics

Featured Products:

Implant(s): Provata Co-Axis 12D 4.0mm x13
Temporary Abutment(s): Scanned for PMMA/Passive abutment
Definitive Prosthesis: Planned for Monolithic Zirconia/ Passive abutment

Surgery and Temporary Bridge: Provata Co-Axis 12D failed maxillary Front

Pre-operative clinical status. Keratinized gingiva surrounds the fractured tooth.

Pre-operative clinical status. Keratinized gingiva surrounds the fractured tooth.

The root is extracted. The buccal bone wall was intact.

The root is extracted. The buccal bone wall was intact.

2 mm twist drill was used to proper depth. A 13 mm implant was planned. Gingiva height above the crest of the bone was 3 mm. The implant was planned to be placed 1 mm sub-crestal.

2 mm twist drill was used to proper depth. A 13 mm implant was planned. Gingiva height above the crest of the bone was 3 mm.
The implant was planned to be placed 1 mm sub-crestal.

The osteotomy was then advanced with 3.3 mm Tapered drill

The osteotomy was then advanced with 3.3 mm Tapered drill

The Provata Co-Axis 12d Implant was  mounted on the dedicated Co-Axis drive and placed to proper depth. The Implant was placed with a final torque of 50 Ncm and an ISQ of 78.

The Provata Co-Axis 12d Implant was mounted on the dedicated Co-Axis drive and placed to proper depth. The Implant was placed with a final torque of 50 Ncm and an ISQ of 78.

The root is carefully extracted with periotom and luxator

The root is carefully extracted with periotom and luxator

3-spade  drill was placed 2/3 down in the socket on the palatial wall.

3-spade drill was placed 2/3 down in the socket on the palatal wall.

Direction indicator was used to verify proper angulation. As a guide for placing a Co-Axis 12 degree implant, align the osteotomy to the incisal edge of the adjacent tooth. Use the dedicated 12d  direction indicator.

Direction indicator was used to verify proper angulation. As a guide for placing a Co-Axis 12 degree implant, align the osteotomy to the incisal edge of the adjacent tooth. Use the dedicated 12d direction indicator.

The osteotomy was then advanced with 4.0 mm Tapered drill to final depth and direction.

The osteotomy was then advanced with 4.0 mm Tapered drill to final depth and direction.

The osteotomy was then advanced with 4.0 mm Tapered drill to final depth and direction.

After Implant placement the gap between the implants and buccal bone wall as well as the extraction sockets on the central incisors were grafted with Osteobiol Mp3 and covered with collagen. Scan Flags ( SF-M) were mounted and scanned with 3-shape IOS.

Temporary prosthesis was manufactured through the scan and milled in PMMA. Passive abutments were cemented to the PMMA temps.

Temporary prosthesis was manufactured through the scan and milled in PMMA. Passive abutments were cemented to the PMMA temps.

Close-up of the temporary restoration with Passive abutments cemented.

Close-up of the temporary restoration with Passive abutments cemented.

Two days post-operative clinical situation at delivery of the temporary prosthesis

Two days post-operative clinical situation at delivery of the temporary prosthesis

Temporary prosthesis mounted

Temporary prosthesis mounted

Two weeks post operative situation

Two weeks post operative situation

Three month post operative clinical situation.  The patient is happy with the  esthetic outcome. Therefore no new impression is made, as the digital file of the temporary prosthesis is used for final monolithic zirconia milling process.

Three month post operative clinical situation. The patient is happy with the esthetic outcome. Therefore no new impression is made, as the digital file of the temporary prosthesis is used for final monolithic zirconia milling process.

The temporary prosthesis is removed.

The temporary prosthesis is removed.

Axial view showing that there are still some unresorbed Mp3 granules in the soft tissue . Minor changes of the buccal bone plate can be seen.

Axial view showing that there are still some unresorbed Mp3 granules in the soft tissue . Minor changes of the buccal bone plate can be seen.

Definitive 4 unite fixed partial denture  in monolithic zirconia and passive abutment.

Definitive 4 unite fixed partial denture in monolithic zirconia and passive abutment.

Axial view of the definitive restoration.

Axial view of the definitive restoration.

The definitive fixed partial denture in place. The restoration was tightened to 35 Ncm.

The definitive fixed partial denture in place. The restoration was tightened to 35 Ncm.

3 y follow up radiographs

3 y follow up radiographs.

The definitive fixed partial denture in place. The restoration was tightened to 35 Ncm.

Southern Implants’ Zygomatic Implant Portfolio:

Paying Tribute

Per-Ingvar Brånemark

Per-Ingvar Brånemark: May 3, 1929 – December 20, 2014.

With the recent launch of the ZAGA Implant, we thought it appropriate to reflect on the journey and individuals that have contributed to Southern Implants’ Zygomatic Implant Portfolio.

First and foremost, Prof. PI Brånemark who designed the first zygomatic implants and pioneered the concept of supporting dentition by way of anchorage in the Zygoma should be credited. Prof Brånemark reported an overall success rate of 97.6% with the placement of over 200 zygomatic implants during the period 1989 to 2001.

Zygomatic bones are an excellent source for prosthetic support, providing a generous amount of bone. Southern’s extra-long Zygomatic and Oncology implants enable this bone to be utilised, whilst bringing the restorative surface closer to an ideal prosthetic position.

Our first significant improvement over that proposed and used by Prof. Brånemark was the change from the 45º angulation in the head of the implant to 55º. The 55º angle provides the correct emergence angle in dental restorations and provides some flexibility in the restorative plane for complex multi-implant mid-facial reconstructions. This was described in a paper published in 2003 by DG Howes, JG Boyes Varley, GA Blackbeard, JF Lownie and PA Betts1. Prof. Brånemark applauded this improvement and invited Drs. Boyes-Varley and Howes to present it at his 40-year celebratory conference in Brazil in 2005. Over and above the improved prosthetic axis, the 55º angle also reduces the stresses within the implants and components by up to 20%.

The next significant contribution to our portfolio was the introduction of the machined body2. This modification was originally proposed for oncology reconstructions, but it was thereafter used for extra-alveolar placement. The machined sections are excellent for exposed soft tissues.

The narrow apex was a ground-breaking addition to our Zygomatic Implant Range. The introduction of the thin apex was only made possible by way of our access to ultra-high strength pure titanium with over 920 MPa.

Just as significant as the hardware developments have been the development of the surgical protocols associated with Zygomatic Implants. The following clinicians have all played a significant role in these developments: John Stella, James Chow, Carlos Aparicio, Greg Boyes-Varley, Ruben Davo, Hermann Kluge, Chris Butterworth, Guy McClellan, Gerardo Peregrino.

Southern Implants were assigned two patents that relate to the Southern Portfolio of Zygomatic Implants, namely the use of ultra-high strength titanium to facilitate the narrow dimensions (Blackbeard, Cumming), and the flat of the ZAGA Implant (Aparicio, Pauk, Cumming).

1 Surgical modifications to the Brånemark zygomaticus protocol in the treatment of the severely resorbed maxilla: a clinical report

2 Boyes-Varley JG, Howes DG, Davidge-Pitts KD, Branemark I, McAlpine JA. A protocol for Maxillary Reconstruction following Oncology resection using zygomatic implants.

Client FocusResearch – The Core of Product Development

Passive Abutments

Morris GA, Prestipino T, Drago C.

Southern Implants’ Novel Passive Abutment: Clinical and Laboratory Procedures for Fabricating a Screw-Retained Fixed Partial Denture. J Dent Technol. 2020 Oct;26–32.

In this technical guideline, Drs. Gary Morris and Carl Drago and Tony Prestipino (USA) describe step-by-step the procedures for fabricating a three-unit screw-retained fixed partial denture using Southern Implants’ unique Passive Abutments.

The Passive Abutment was designed to remedy unwanted prosthesis distortion during casting. This may cause misfit and impassivity, which can result in microbial penetration, screw loosening or fracture. The Passive Abutment features a polished titanium base with a plastic burnout cylinder. A Luting Screw is used to clamp the titanium base onto the analogue during the process of luting the casting onto the interfacial component. The precision-manufactured titanium base ensures a perfect fit between crown and implant platform for cast restorations.

The following technique tips were highlighted in this article:

  • When assembling the abutment on the analogue in the laboratory, do not overtighten the brass laboratory screw as this may distort the plastic sleeve.
  • Use the correct size of Southern Implants special hand-held Reamer (LT18-2.4, LT18-2.6 or LT18-2.8) to prepare the screw seat surface inside the casting to ensure proper seating and tightening of the prosthetic screw.
  • Do not overtighten the PEEK Luting Screws as this may result in fracture of the head of the screw.
  • It is critical to limit the amount of resin cement and avoid the area immediately around the PEEK screw heads when affixing the casting to the titanium base. Excess cement may extrude through the screw holes and inadvertently lock the luting screws into the cement.

The authors noted that the cement line of the finished prosthesis was not even between the components, which is a tell-tale indication that without the passive abutment, there would have been casting misfit.

Read the entire article here.

MAX Wide-Body Implants

Hattingh A, De Bruyn H, Van Weehaeghe M, Hommez G, Vandeweghe S. Contour Changes

Following Immediate Placement of Ultra-Wide Implants in Molar Extraction Sockets without Bone Grafting. J Clin Med. 2020 Aug 4;9(8).

In the final paper of his PhD thesis, Dr. André Hattingh (UK) presented a seminal paper evaluating ridge dimension changes after placing MAX implants in molar extraction sockets, without bone grafting. Impressions were taken at extraction, after 4 months, and at 1 year. Sixteen implants were in maxillary molar sites and 11 in mandibular molar sites.

Overall ridge changes were as follows:

MAX Wide-Body Implants

The study concluded that while immediate implant placement can mitigate the severe crestal reduction observed in delayed cases, clinicians should still be aware of and plan for a significant amount of horizontal and vertical shrinkage and consider subcrestal placement with augmentation at time of placement. Atraumatic extraction, correct technique and proper positioning of MAX implants is paramount to ridge preservation.

ILZ Mini-Implants

Van Doorne L, De Kock L, De Moor A, Shtino R, Bronkhorst E, Meijer G, et al.

Flaplessly placed 2.4-mm mini-implants for maxillary overdentures: a prospective multicentre clinical cohort study. Int J Oral Maxillofac Surg. 2020 Mar;49(3):384–91.

Mini-dental implants (MDIs) are one-piece ball-overdenture implants with diameter Ø2.4 mm and are becoming ever more popular for the restoration of narrow ridges, especially in older patients. However, owing to the often-compromised health and advanced age of these particular patients, as well as the small bone-to-implant contact surface area of the implant, failure rates may be higher than for standard implants. A recent systematic review of 15 papers found a failure rate of 31.7% for MDIs in the maxilla.

Nonetheless, prosthetic success may still be achieved with one or two failed implants, and patients consistently report improved quality of life with MDIs.

Dr Van Doorne and colleagues at Ghent University (Belgium) presented 2-year results of 31 patients treated with 4-5 MDIs in the maxilla. All patients were >50 years old and had been using dentures. Implants were placed flaplessly in sites prepared using a single-drill protocol. No suturing was needed, and the patient’s existing denture was relined to accommodate the balls during healing. Overdenture caps were connected after 6 months.

At 2 years post-placement, 32 implants had failed in 16 patients (17.3%). All failures occurred before the final prosthesis was connected. Two patients lost five or six MDIs resulting in 2 prosthetic failures (6.5%). Implant loss was significantly affected by gender, but not smoking or location. The mean pain score out of 10 was 4.1 ± 2.8 on day 1 and 1.1 ± 1.7 on day 7. Ninety-six percent of the patients said they would recommend the treatment to others. Despite higher failure rates, prosthetic success was acceptable.

Careful planning and guiding are advised so as not to perforate the nasal or sinus floor. Redirection during drilling should be avoided so as not to break the narrow (Ø2 mm) twist drill.

About the INVERTA® Implant Registry

November 2020

By: Tamsin Cracknell

Online clinical trial registries were originally tools used by the pharmaceutical world to capture massive amounts of data about performance of drugs in the field. Registries allow for secure and anonymous storage and backup of data, accessible from anywhere in the world at any time, and make the statistical analysis of data much easier and largely free of human error.

With the advent of the new and stringent EU regulations for marketing medical devices (MDR 2017/745), clinical registries are becoming ever more popular with device manufacturers for obtaining up-to-date information about the performance of their products in the real world as well. One of the intensive new requirements set by the MDR regulations is that manufacturers must continuously and proactively collect end-user feedback.

Pre-built registries are available via pay-per-use models but are expensive and more suited to pharmaceutical trials. Southern Implants therefore undertook to build our own clinical registry from scratch – a process that has been 3 years in the making and is constantly evolving.

The registry was initially used for beta testing of the then-newly released INVERTA Implant in the USA. It was subsequently extended to the UK and Australia. After every case, clinicians create a patient file online and capture details like state of dentition, implant code and lot number, insertion torque, type and time of restoration, etc. We can then filter this data and analyse it for trends or publication.

The registry framework is expanding rapidly, and the goal is to eventually use it as a channel for feedback on all Southern Implants products. This will make it even easier for our customers from around the world to have their input heard.

Customer Focus

Dr. Howard Gluckman

Dr. Howard Gluckman

Dr. Howard Gluckman

Dr. Howard Gluckman from Cape Town was appointed to the role of Adjunct Assistant Professor in the Periodontics Department in the Associated Faculty of the School of Dental Medicine at Penn University.

Dr. Gluckman completed his dental training at the University of Witwatersrand in Johannesburg in 1990. After spending several years in a general practice, he completed a 4-year full time degree (Cum Laude) in Oral Medicine and Periodontics at the University of Stellenbosch in Cape Town in 1998. He was closely involved in the development of the postgraduate diploma in Implantology at both the University of Stellenbosch and later at the University of Western Cape. He is currently in full time private practice in Cape Town, South Africa. He is also the director of the Implant and Aesthetic Academy, which is a private post-graduate training facility in South Africa currently providing a complete postgraduate training program in Implantology. The Academy is accredited by The University of Frankfurt. He has been involved in Implantology training for 18 years.

Prof. Chris Butterworth

Chris Butterworth

Professor Chris Butterworth

Prof. Chris Butterworth, from the Liverpool Head and Neck Centre, was recognised by the AAOMS (American Association of Oral and Maxillofacial Surgery) for his recent research presentation at their virtual meeting. The “ZIP flap” technique, which was pioneered at the Liverpool Head and Neck Centre is gaining momentum and providing incredible results for patients with malignant tumours of the upper jaw.

News Focus

UK:

Getting customers back to work: Fit testing in the UK

After months of uncertainty and frustration in the UK as authorities grapple with trying to balance their perspectives of public health, evidence (or lack of, as the case may be) with the provision of safe dentistry, it’s been a welcome relief to see customers being able to get back to work and treat their patients again from June 2020.

Whilst it was a great relief to many of our customers to open again, albeit with significant additional safety measures and procedures to adhere to, a key bottleneck in returning to work was in sourcing appropriate PPE and having masks fit-tested.

Enter Team SIUK!

Always doing whatever we can to support our customers, SIUK anticipated this hurdle and were fortunate to be able to arrange a certified face fit-tester course for our team. The full-day course was excellent, and our team are now all certified and competent qualitative face fit-testers. The SIUK team did a total of 771 fit tests for our customers and others, getting many of them back to work as soon as possible. Colin Hart, our Regional Manager for Scotland, performed over 500 tests!

It was a privilege to be able to play a part to getting our customers back to work.

 

North America:

Southern Implants TiBase Abutments Now Available

TiBase

TiBase Abutments Unique Design:

  • Used with leading CAD/CAM systems by scanning the abutment directly or using digital CAD/CAM libraries.
  • Made from Titanium, the abutment creates a Ti Ti connection between the abutment and implant.
  • Machined grooves increase cement retention.
  • Gold anodization improves aesthetics.
  • Flat on the side of the abutment provides a scannable and indexing feature to the abutment.
  • Available in 3 collar heights, as well as engaging and non-engaging.

Event Focus

South Africa:

The “Preservation Tour”
“Life is full of opportunities; Success is about taking the right ones”

The tour of presentations concentrated on Southern’s Innovative Treatment Solutions that would help the practitioner in recalling patients that had previously not followed through with Implant treatment. We initiated a voucher system allowing a considerable discount to help practices and ultimately patients to get their implant treatments done.

Italy Users Conference 13 April 2019

Bringing Together Remarkable Leaders Specialized in Treating the Severely Atrophic Maxilla

SINA was honored to bring together a group of renowned educators in a virtual expert forum on Zygomatic Implant Dentistry Webinar. This stimulating and provocative program targeted advanced implant dentist attendees and was aimed to highlight new approaches that are leading to superior outcomes. The live webinar was held on November 6 and focused on important topics as the evolution of this treatment therapy moves very quickly. The 5-Speaker roster, and astute moderators captivated attendees who joined from all over the globe.

Sold Out Virtual Zygomatic Hands-On Delights All

During this challenging time to meet in person, SINA insisted that it do something to fulfill the high levels of interest it is receiving for the Southern Zygomatic Implant Portfolio. Hence, a virtual hands-on workshop was created. The sold-out workshop titled Practical Guidelines for Treatment of the Severely Atrophic Maxilla was facilitated by Dr. Greg Boyes-Varley from South Africa and broadcast live to the USA on Saturday, November 7. Attendees from the West to East Coasts followed Dr. Boyes-Varley through a patient surgery and performed their own surgery on the model of the patient with Southern Zygomatic Kits, Implants and Abutments. Feedback from the first of its kind hands-on workshop was positive, attendees enjoyed the interactivity, as well as using their own equipment, at their offices, to do the model surgery as one participant commented “From a practical standpoint, this worked very well being able to use our own equipment in our own surroundings.” The success of the program ensures similar programs in the future. Stay tuned for the next Zygomatic Virtual Hands-On Workshop to be announced!

Australia: In-person workshops are back!

After the many challenges brought about by the COVID-19 pandemic, Southern Australia is happy to get back to providing in-person workshops as learning opportunities for customers and friends. The first one was held in November, with speakers Dr. Dale Howes and Dr. James Digges presenting about Co-Axis® and INVERTA® Implants, Dr. Rajiv Verma, Dr. Cameron White and Dr. Ehsan Mellati presenting about Versah Dr. Michael Walker and Kylie Harstang presenting about PRF & Venipuncture.

Upcoming Events with Southern Implants

South Africa

SAVE THE DATE!
Southern Implants International Forum 2022
March 20-23, 2022
KwaZulu Natal, South Africa