FAQs - DentoClude F

Frequently Asked Questions

Concerns about the interaction between the cement and the DentoClude™ F if used under inlays and on lays as claimed.

DentoClude™ F is a USFDA approved novel/proprietary finely ground bioglass indicated to use as a desensitizing agent for dentin surfaces by blocking dentin tubules to help prevent micro-leakage and to use under direct or indirect restorations following dentin etch and prior to dentin adhesive application.

Inlays and on lays are cemented in the mouth using adhesive resin luting cements. These materials are placed in the inlay/ on lay and placed onto the prepared tooth. Bonding agents can be applied to dentine before cementation of inlays and on lays.

Literature supports the usage of bioactive glasses in various aspects of dentistry including dental restorative materials. Many luting cements and dental adhesives were enhanced with bioglass for its biocompatibility and to decrease the microleakage and improve the bond strength without compromising their mechanical properties.

Bond Strength may decrease because of the interference of another product like DentoClude™ F in restorations.

In-vitro study demonstrated that Bioactive glass powder added to the resin-dentin bonded interface that previously has been shown to reduce leakage does not decrease the bond strength. Indeed it showed superior bond strength compared to the control by three times. No adhesive failure was seen. (Reference: Sally Marshall paper/ slides)

A Study was conducted to compare the effect of bioactive glass, hydroxyapatite, and diode laser desensitization on shear bond strength of resin composites to dentin at different time intervals. Seventy-two caries-free maxillary premolars were selected. Buccal surfaces were flattened to expose dentin. Teeth were divided into four groups according to treatment modality (control with no pre-treatment, Tooth paste with bioactive glass, Hydroxyapatite Desensitizer, diode laser). Bonding was performed using self-etch adhesive followed by composite build up. Universal testing machine was used to determine shear bond strengths immediately after bonding, after 3 months, and 5 months storage in artificial saliva. Pre-treatment with BG and hydroxyapatite desensitizers increased, whereas diode laser decreased mean shear bond strength of composite to dentin as compared to control group. No statistical significant difference in shear bond strength values was seen in groups after storage.

Reference:

Gupta T, Nagaraja S, Mathew S, Narayana IH, Madhu KS, Dinesh K. Effect of Desensitization Using Bioactive Glass, Hydroxyapatite, and Diode Laser on the Shear Bond Strength of Resin Composites Measured at Different Time Intervals: An In vitro Study. Contemp Clin Dent. 2017 Apr-Jun;8(2):244-247. doi: 10.4103/ccd.ccd_155_17. PMID: 28839410; PMCID: PMC5551329.

Questions related to its usage under self-etch adhesives. DentoClude™ F needs to be used after etching and before bonding but with self-etch adhesives being on market and are widely used, how is DentoClude™ F to be used along with the self-etchant adhesives. If DentoClude™ F is applied before the etchant, it will be removed by the acid present in the etchant.

DentoClude™ F can be used immediately after self-etchant adhesive as the dental bonding composition dissolves the smear layer, demineralizes the dentin to expose dentin matrix and primes the etched dentin surface. In addition, the bioactive glass and adhesive penetrate the demineralized dentin to form the hybrid layer. Then the dental bonding can be cured.

Reference:

[0084] In other embodiment the dental bonding compo-sition can include a self-etching adhesive. As described herein, the self-etching adhesive may include a self-etching primer (e.g. an acidic monomer), a bioactive glass, an adhe-sive, and a solvent. In these embodiments, the solvent may be an alcohol, such as but not limited to ethanol. In these embodiments, the self-etching primer may be an acidic monomer as described herein. In this method, upon applica-tion of the dental bonding composition, the dental bonding composition dissolves the smear layer, demineralizes the dentin to expose the dentin matrix, and primes the etched dentin surface. In addition, the bioactive glass and adhesive penetrate the demineralized dentin to form the hybrid layer, in a single application. Subsequently, the dental bonding com-position may be cured as described herein. In some cases, the method also includes contacting the adhesive layer with a dental resin composite such that the dental resin composite is adhered to the dentin.

Studies on Depth of the Penetration.

Energy-dispersive x-ray analysis/EDX maps of a study conducted to test the hypothesis that the presence of bioactive glass, which is known to precipitate hydroxyapatite when placed in aqueous environments that contain calcium and phosphate, will reduce leakage of resin-bonded dentin showed that bioactive glass particles were embedded in the dentin to a depth of 5-10 µm below the surface. The maps further suggested that the materials are present in both the adhesive and the dentin itself.

Reference:

Diana N. Zeiger, Larry G. Watanabe, Kuniko Saeki, Sally J. Marshall, Grayson W. Marshall. Bioactive glass reduces microleakage in resin-bonded dentin. Zeiger: 8/16/07 For Dental Materials (Elsevier).

Availability of hand outs on supporting data.

Data supporting the safety and efficacy of ingredients of DentoClude™ F is available in public domain. Data can be provided upon request.

Any publications on the studies conducted and on the product.

In-Vitro and In-Vivo studies were conducted to test the efficacy and viscosity of DentoClude™ F and all of them demonstrated positive results with no deleterious effects on bond strength.

Reference:

Sally Marshall data and Cumberland clinical studies data.

The longevity of the desensitizing agent.

Bioactive glass may be incorporated into bonding process without deleterious effects on bond strength.

Reference:

Diana N. Zeiger, Larry G. Watanabe, Kuniko Saeki, Sally J. Marshall, Grayson W. Marshall. Bioactive glass reduces microleakage in resin-bonded dentin. Zeiger: 8/16/07 For Dental Materials (Elsevier).

How effective is the product in bone regeneration and supporting data.

A review of the present literature supports clinical applications of prefabricated implants made of Bioglass ceramics, as has been used in calvarial and midface bone reconstructions as well as for the repair of orbital floor fractures. Also, present experience with Bioglass in particulate form, preferably mixed with small amount of autogenous bone, support the convenience of this biomaterial over alternate forms of synthetic graft materials.

A 5-year evaluation on Bioglass cones was conducted to examine the effectiveness of Bioactive cones as space fillers after removal of tooth roots to delay the resorption of alveolar ridges (Stanley et al). High rate (85.7%) of cone retention after 5 y Placement of Bioglass into fresh sockets promoted alveolar ridge preservation and is said to be a material of choice for endosseous ridge maintenance implants to prevent alveolar ridge resorption.

Retrospective review was conducted to evaluate Particulate bioglass as a grafting material in the treatment of periodontal intrabony defects. Results demonstrated the efficiency of Bioactive glass as an adjunct to conventional surgery in the treatment of intrabony defects.

Histological observations on biopsies harvested following sinus floor elevation using a bioactive glass material of narrow size range were made to evaluate the bone augmenting capacity of Bioactive glass particles in human sinus floor elevations. Results demonstrated that a 1:1 mixture of autogenous bone/Bioactive glass particles seemed a promising alternative to autogenous bone only, when low amounts of bone tissue are available for sinus augmentation

Reference:

Clark AE, Stanley HR. Clinical trials of bioglass implants for alveolar ridge maintenance. J Dent Res. 1986;65:304.

Zamet JS, Darbar UR, Griffiths GS, Bulman JS, Brägger U, Bürgin W, Newman HN. Particulate bioglass as a grafting material in the treatment of periodontal intrabony defects. J Clin Periodontol. 1997 Jun;24(6):410-8. doi: 10.1111/j.1600-051x.1997.tb00205.x. PMID: 9205920.

Ette S. Tadjoedin, Gert L. De Lange, D. M. Lyaruu, Luit Kuiper, Elisabeth H. Burger. High concentrations of bioactive glass material (BioGran®) vs. autogenous bone for sinus floor elevation. Clinical Oral Implants Research

Cost effectiveness of the product.

DentoClude™ F is priced as premium per the cost and value based pricing with an intent to bring an efficacious product on to the market to address one of the most prevailing dental health issue, Dentinal Hypersensitivity.

Details on how to store the product for a day or two for reuse.

The intent to market the DentoClude™ F as a single use is to ensure reduced risk of contamination. If accidentally opened and need to reuse in a day, ensure DentoClude™ F to remain in the original well as provided, seal back and refrigerate.

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Regulatory Approvals FDA International India thru CDSCO U.S. Patent No. 11,266,576 / US: 11,351,019

Regulatory Approvals FDA International India thru CDSCO U.S. Patent No. 11,266,576 / US: 11,351,019

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