BioCellgraft Inc. stays the course ahead and sets sail vigorously to reach its ambitions in the field of innovative oral tissues treatment and oral health.
It is the culture of BioCellgraft Inc. to confront and combine sophisticated ideation and conceptualisation with pragmatic approaches and controlled technical procedures to serve patients, dental professionals and customers.
We learned from our last edition of “To my Fellows on the Battlefield” that if Randomized Controlled Trials (RCTs) are intended to determine efficacy, Observational Studies are used to measure the effectiveness of a treatment/intervention in real world scenarios.
The intensification of BioCellgraft Inc. activities in the field of Observational Studies is exactly what is happening currently.
To progress systematically forward it was decided to focus this first phase on our flagship product Orafyl® and on one key indication which represents about 2 million clinical cases each year in the USA: alveolar extraction socket regeneration. This indication offers both soft and hard tissues challenges to overcome.
Due to its abundance in extra cellular matrix components, the human placental derivatives is considered the biological adjuvant of choice for oral surgeries. Among the placental components rises the chorionic plate that is composed of a thick layer of connective tissue (elastin, collagen, proteoglycans such as laminin and fibronectin).
To extract the usable chorion, the donated human placentas obtained from normal, healthy and full-term pregnancies undergo a series of controlled scraping and washing to remove viable cells from the raw material. Once washed, the chorionic plate is homogenized into a paste and lyophilized, then it is grounded into the connective tissue matrix and filled into the desired size vial or syringe. The finished product is an allogeneic particulate Human Placental Connective Tissue Matrix (HPCTM) devoid of cells, hormones, growth factors, and cytokines. The obtained matrix retains its fundamental structural and functional characteristics of connective tissue, providing mechanical/structural support and elasticity.
The commercial form of HPCTM branded Orafyl® is regulated by the US Food and Drug Administration (FDA) under Section 361 of the Public Health Service Act as a human cell, tissue, and cellular and tissue-based product (HCT/P, 21 CFR, Part 1271.10(a) (Celularity, Florham Park, NJ, USA).
The use of Human Placental Connective Tissue Matrix (HPCTM) as an adjunctive in alveolar ridge preservation offers a scaffold for the overlaying soft tissue hence reduces its shrinkage and accelerate wound closure.
Patients needing multiple teeth extraction were included in a clinical study, the sockets were divided between test and control (split mouth design principle) and flapless alveolar ridge preservation procedures were performed. Orafyl® was gently mixed with allogenic Freeze-Dried Bone Allograft FDBA (Maxgraft cortico-cancellous, Botiss, Germany). Initial cone beam computed tomography, intra-oral scans and clinical photographs were taken at 10, 21, 30 days post-operative to assess the healing kinetics and quantify the regenerated soft tissue.
The systematic clinical observations and super-impositions of different intra-oral scans showed less inflammation, a faster wound closure, less collapse and thicker soft tissue in the test sites. In all cases the test site volume was preserved or even increased.
It appeared that using a flowable Human Placental Connective Tissue Matrix (HPCTM) as an adjunctive agent in alveolar ridge preservation boost the soft tissue healing and reduce the soft tissue based coronal shrinkage.
Beside independent clinical cases this first systematic study confirms the safety and efficacy of Orafyl® for dental applications.
The bioactivation of bone grafting material with Orafyl® being demonstrated, the range of indications shall be broaden to gingival thin biotype reinforcement, gingival recession, interdental papilla loss or volume reduction (black triangle) and soft tissue management around implants, abutments and restorations (gaps filling).
Proceeding further BioCellgraft Inc., shows its willingness to prove that Oral Health is Overall health.
