Reversible Pulpitis, Pulpitis, Caries,Dental, Caries Class I, Caries; Dentin, Caries
Conditions
Keywords
Glass ionomer, Chitosan, Titanium dioxide, Titanium dioxide nanoparticles, Chlorhexidine, indirect pulp capping, Alternative restorative technique, stepwise caries excavation, antibacterial restorative, incomplete caries removal, primary molars, early childhood caries
Brief summary
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
Detailed description
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.
Interventions
DRUGGlass Ionomer
Glass ionomer filling material would be modified accordingly or used as is
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
DRUGChlorhexidine Diacetate
Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716
DRUGTitanium Dioxide
Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), \>99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
The teeth will be primary molars selected from patients presented to the outpatient clinic that are * Healthy patients. * Age: 4-8 years. * Children having at least one primary molar with only occlusal caries having dentine lesions wide enough for the smallest excavator to enter (Ø=0.9 mm).
Exclusion criteria
* Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis. * Children with systemic diseases. * Patients with history of active para-functional oral habits, xerostomia. * Patients who will have difficulties in cooperating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibacterial | 9 months | 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 |
| Clinical performance | followup 9 months | 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. |
Countries
Egypt
Outcome results
None listed