Molecular basis for soft tissue management of gingivitis, periodontitis and peri-implant mucositis using an FDA cleared inflammation-targeting hydrogel – high potency polymerized cross-linked sucralfate - A case series illustrated profile of a drug device (Orafate) and the clinical rationale for use

Abstract

Background: Current practice of soft tissue management (STM) targets the biofilm and its invasion into gingival soft tissue and periodontal space. Prior to FDA clearance of high potency polymerized cross-linked sucralfate (Orafate) there were not therapeutic options that targeted inflammation of the gingival and periodontal soft tissue structures. High potency polymerized cross-linked sucralfate (HPPCLS) for soft tissue management of oral inflammation represents an advance toward balanced medical management of oral inflammatory disease and wounds of oral surgery.

Regulatory Dichotomy of Sucralfate, Its history and the new Bioadhesive polymerized Sucralfate barrier therapy for Oral health, Oncology support and Gastrointestinal disorders

“…Moisture facilitated polymerized Sucralfate applied by caking bulk amounts of powdered Sucralfate to gingival disorders like periodontitis, chronic purulent gingivitis and tooth extraction wounds have resulted in rapid resolution of those medical conditions. (46) The organic acid-facilitated polymerized Sucralfate in Orafate/OraHeal requires but a fraction of amount of moisture-facilitated polymerized Sucralfate to achieve similar outcomes (47) for gingivitis, for cold/hot dental pain, for post-cleaning gingival pain and for labial aphthous ulcers. Orafate (OraHeal) is a Class III medical device authorized by US FDA 510k division with pending CE marks for Europe and Class C authorization in India.…”