1. Is Super Seal® FDA compliant? YES. Super Seal® holds an cleared 510(k) submission since 1998. Phoenix Dental is compliant with FDA cGMP, current good manufacturing practices. In addition, Phoenix Dental’s quality management system is ISO 13485, CMDCAS (Canada) and JPAL (Japan) compliant. The product Super Seal® holds a CE mark (European Community) for conformity to the Medical Device Directive 93/42/EEC.
2. How does Super Seal® work? Dentin, enamel and cementum of the tooth are each composed of high concentrations of calcium hydroxyapatite, CAHA, at an alkaline pH. Super Seal® and CAHA react with each other, creating a fine nano-crystal precipitate, calcium oxalate, CAOX, within the dentinal tubule complex. These nano-crystals are biologically bound to the vital substrates, leading to a long-lasting seal. Super Seal® is water-based and will re-wet the substrate to re-establish the collagen for bonding.
3. What are some of the clinical benefits of using Super Seal®? Super Seal® is a non-toxic agent with several beneficial clinical uses such as the following: Immediate treatment to stop tooth sensitivity caused by exposed dentin or root surface.Rewetting chair-side aid for diagnosing a split tooth syndrome---even before an X-ray is taken. Before, during and after any sort of hygiene prophylaxis and root scaling.Place immediately following periodontal scaling to remove debris and enhance healing surface before the periodontal tissues are replaced.Ideal non-toxic cleaner to remove temporary cements, i.e. ZnPhos, ZnOE, etc., from either the restoration and or crown, inlay or onlay interfacial surface. Place completely around any restoration margin to treat post-cementation sensitivity that may occur from marginal leakage.Ideal to prevent all tooth sensitivity before tooth bleaching as well as immediately after any in-office or at home patient whitening procedure.
4. Does Super Seal® interfere with self etch systems? NO. The calcium hydroxyapatite (CAHA) component of peritubular dentin is a much more dense and alkaline complex than intertubular CAHA. Consequently, Super Seal®’s low pH level initially removes both the smear layer and smear plugs. Super Seal® does not leave a surface layer over the intertubular [low mineral density] complex as do other oxalate systems. Therefore, complete interdiffusion of the adhesive is easily obtained through the non-distorted collagenous fibers of the dentin. Since the real cohesive bonding takes place in the intertubular dentin and not within the peritubular complex, Super Seal® will not interfere with the intertubular adhesive/bonding process.
5. How do self etch systems [acidic hydrophilic primers] diffuse through Super Seal®? The entire physiological process is extremely dynamic and occurs quite rapidly once set in motion. Once the CAOX nano-crystals are formed within the peritubular dentin [intratubular zone] following Super Seal® placement, fluid flow is extremely diminished. However, even though the nano-crystals fill in the tubules, think of the blockage as a function of pouring water into a glass of sand. The water will still pass between the crystals---although it is a very slow flow through the mass of sand---any particle that is larger than the nano-crystals will be stopped due to its size difference. This is why Super Seal® works clinically, as the fluid flow slows to the point of negating the patient’s feeling of dentin sensitivity.Once Super Seal® is applied and has chelated to the peritubular complex; the acidic hydrophilic primer is then placed directly onto the cavity surface. These hydrophilic agents, like ethanol or acetone are drawn towards the very wet dentin substrate and in so doing, will diffuse (penetrate) through the nano- crystals. The adhesive then polymerizes and moves from a liquid state-—through a gel state---to a solid state.Once the dynamic events of Super Seal® placement occur and a following hydrophilic agent is placed proceeding through a gel to solid set---then no other fluids will flow through the hybrid zone.
6. Does acid etching improve the function of Super Seal®?NO. Pre-etching does not improve the clinical outcome or performance of Super Seal®.
7. Should the clinician use a self-etching agent before placing Super Seal®? NOT NECESSARY. Place Super Seal® before any self-etching system as adhesive systems will easily diffuse through the CAOX nano-crystals of Super Seal®.
8. How is Super Seal® different from other desensitizers currently on the market? Super Seal® is water-based making it biologically compatible to all soft tissue. Most other products currently being used today contain glutaraldehyde, HEMA or benzalkonium chloride that are harmful to soft tissue. Super Seal®contains no toxic substances that can irritate vital dental pulp, gingival or alveolar and periodontal tissues.
9. When should Super Seal® be used? Super Seal® may be used for any patients with thermal tooth sensitivity such as cold, sugars, acids, osmotic, before and after prophylaxis and bleaching, on any exposed root surface, following periodontal surgery to occlude dentinal tubules, under restorations such as amalgams, composites, crowns, inlays, onlays, or veneers. It prevents patient sensitivity during crown temporization. It does not build up film thickness. Super Seal® is a water-based product and may be used as a re-wetting agent before impressions to prevent bubble formation.
10. Can Super Seal® be used in several coats to seal the tubules? YES. Super Seal® chemically chelates with the calcium of the tooth substrate (enamel, dentin and cementum.) It does not keep building upon itself to form a thicker layer. It has been clinically proven to effectively decrease hypersensitivity on those clinical cases when used multiple times.
11. Is bond strength decreased when Super Seal® is used with today’s adhesive systems? NO. Studies have shown that Super Seal® does not affect bond strengths when applied before an adhesive system.
12. How many applications can I expect from a bottle of Super Seal®? An 8 mL bottle contains enough Super Seal® for approximately 160 drops/applications. The 4 mL bottle contains enough Super Seal® for approximately 80 drops/applications. Each 1 mL of product is good for approximately 20 drops/applications.
13. What is the shelf life of Super Seal®? The expiration date of Super Seal® is two years from the month of manufacture. The expiration date appears prominently on the back of the Super Seal® carton and dropper bottle in a year and month format, a four-digit year and a two-digit month, yyyy-mm.
14. Can Super Seal® be warmed in the bottle for a patient with cold sensitive teeth? YES. Super Seal® may be warmed in the bottle with the cap tightly closed in a warm water cup, slightly above body temperature---making Super Seal® more soothing for application to the tooth. This will not interfere with the efficacy.
15. What effect does Super Seal® have at the time of periodontal surgery? Super Seal® has a unique chemical action to form a biologically acceptable complex that is clinically found to have no inhibition of soft tissue or PDL healing. Super Seal® removes the smear debris and leaves a biologically clean surface that encourages tissue recognition for healing without patient sensitivity.
16. Is light curing, mixing or rinsing required for Super Seal®? NO. Super Seal® does not require any curing, mixing or rinsing. It is fast and easy to apply. Just one application with a cotton pellet and a gentle air-drying should provide the patient immediate relief.
17. Is Super Seal® being used by any leading clinicians? Super Seal® is used by tens of thousands of clinicians all around the world and endorsed by the following: Robert C. Margeas, DDS; Arthur (Tony) Tomaro, DDS; Constantine Pavlakos, DDS; John D. Harker, DDS; Dennis Negata, DDS; Rhys Spoor, DDS; George Freedman, DDS, FAACD, ABAD; and Charles Foy Jr., DDS.