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The study is a randomized clinical trial that assesses the clinical success and the antibacterial effect on carious dentine of glass ionomer when modified with Chitosan and/or Titanium dioxide nano particles vs the control group of modification with Chlorhexidine as control when used in primary molars
Participants will be recruited from the acquitted to the clinic of pediatric dentistry department , Faculty of Dentistry of Ain Shams University. random allocation of the participants where indirect pulp capping is indicated so that modified Glass ionomer would be used as the filling material.
partial removal of caries is done then caries sample would be taken and sent for a microbiological evaluation and then, cavity dimensions is recoded, finally placement of the modified glass ionomer in the prepared cavity.
In a total period of 9 months the patients will be followed every 3 months for clinical evaluation and in the final visit the filling would be removed and another bacterial sample would be taken for comparison, then a permanent filling is placed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chitosan Glass ionomer | Experimental | purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid to be used to modify the stock liquid provided with the glassionomer Fuji IX to have 10% v/v chitosan. will be placed in the prepared cavity over the last layer of caries |
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| Chitosan/Titanium dioxide nanoparticles Glass ionomer | Experimental | The stock liquid provided with the glassionomer Fuji IX will be modified with 10%v/v purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid. The Powder will be modified with 3% titanium dioxide nanoparticles will be placed in the prepared cavity over the last layer of caries |
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| Chlorhexidine glass ionomer | Active Comparator | Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v |
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| Glass ionomer | Placebo Comparator | Stock powder and liquid Fuji IX from GC japan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glass Ionomer | Drug | Glass ionomer filling material would be modified accordingly or used as is |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibacterial | Dentin samples incubated on 2 culture mediums and total bacterial count by counting colony forming units will be counted. Higher number means Less antibacterial effect | 9 months |
| Clinical performance | "Modified United States Public Health Service Ryge Criteria" for Direct Clinical Evaluation and rating of Restoration.measuring color match, anatomic contour, marginal integrity, cavosurface marginal discoloration, secondary caries, surface texture, gross fracture. each outcome will be graded Alpha(A) for the highest score, Bravo(b) for moderate score, and Charlie(C) for the lowest score. | followup 9 months |
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Inclusion Criteria:
The teeth will be primary molars selected from patients presented to the outpatient clinic that are
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariem Wassel, Assistant professor | Ainshams University | Study Chair |
| Noha Kabil, Professor | Ainshams university | Study Director |
| omar A Hodhod, Dentist | British University in cairo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Ain Shams University | Cairo | 1156 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31686917 | Background | Mulder R, Anderson-Small C. Ion release of chitosan and nanodiamond modified glass ionomer restorative cements. Clin Cosmet Investig Dent. 2019 Sep 6;11:313-320. doi: 10.2147/CCIDE.S220089. eCollection 2019. | |
| 28560054 | Background | Wassel MO, Khattab MA. Antibacterial activity against Streptococcus mutans and inhibition of bacterial induced enamel demineralization of propolis, miswak, and chitosan nanoparticles based dental varnishes. J Adv Res. 2017 Jul;8(4):387-392. doi: 10.1016/j.jare.2017.05.006. Epub 2017 May 17. |
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All participants and assessors will be masked,the wil just deal with the randomized numbers.
except the care provider because the materials consistency before mixing is obvious in 2 of the 3 groups
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| Chitosan Low Molecular Weight (20-200 Mpa.S) | Drug | deacetylated chitin, poly(D-glucosamine) purified by dissolving in 0.1 mol/L acetic acid, then precipitated in 0.1 mol/L sodium hydroxide and the precipitate will be washed with ethanol/water (70/30 v/v) mixture followed by freeze drying |
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| Chlorhexidine Diacetate | Drug | Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716 |
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| Titanium Dioxide | Drug | Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), >99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332 |
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| 28190299 | Result | Ibrahim MA, Meera Priyadarshini B, Neo J, Fawzy AS. Characterization of Chitosan/TiO2 Nano-Powder Modified Glass-Ionomer Cement for Restorative Dental Applications. J Esthet Restor Dent. 2017 Apr;29(2):146-156. doi: 10.1111/jerd.12282. Epub 2017 Feb 12. |
| 26079388 | Result | Ibrahim MA, Neo J, Esguerra RJ, Fawzy AS. Characterization of antibacterial and adhesion properties of chitosan-modified glass ionomer cement. J Biomater Appl. 2015 Oct;30(4):409-19. doi: 10.1177/0885328215589672. Epub 2015 Jun 15. |
| 27766712 | Result | Kabil NS, Badran AS, Wassel MO. Effect of the addition of chlorhexidine and miswak extract on the clinical performance and antibacterial properties of conventional glass ionomer: an in vivo study. Int J Paediatr Dent. 2017 Sep;27(5):380-387. doi: 10.1111/ipd.12273. Epub 2016 Oct 21. |
| ID | Term |
|---|---|
| D011671 | Pulpitis |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
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| ID | Term |
|---|---|
| C015897 | glass ionomer |
| C110713 | fuji IX |
| D002710 | Chlorhexidine |
| C009495 | titanium dioxide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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