Early Childhood Caries Clinical Trial
Official title:
Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors
Verified date | April 2023 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to evaluate the clinical success of modified celluloid strip crown restorations applied using interim therapeutic restoration and high-viscosity glass ionomer cement to the maxillary anterior teeth of children with early childhood caries and cooperation problems.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 6 Years |
Eligibility | Inclusion Criteria: - Read the informed consent form and agree to participate in the study - Healthy children, aged 2-6 years - Presenting at least one primary anterior tooth with a class I, II, IV or V caries lesion Exclusion Criteria: - Uncooperative children - The need for vital or non-vital endodontic treatment in the primary tooth to be treated - Previously restorated tooth - Presence of bruxism, Class III occlusion or deep bite |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara | Altindag |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Friedl K, Hiller KA, Friedl KH. Clinical performance of a new glass ionomer based restoration system: a retrospective cohort study. Dent Mater. 2011 Oct;27(10):1031-7. doi: 10.1016/j.dental.2011.07.004. Epub 2011 Aug 15. — View Citation
Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options. Pediatr Dent. 2016 Oct;38(6):55-56. No abstract available. — View Citation
Policy on Interim Therapeutic Restorations (ITR). Pediatr Dent. 2018 Oct 15;40(6):58-59. No abstract available. — View Citation
Waggoner WF. Restoring primary anterior teeth: updated for 2014. Pediatr Dent. 2015 Mar-Apr;37(2):163-70. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to 12 months regarding "Anatomic form" | alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does | baseline, 3-month, 6-month,12-month | |
Primary | Change from baseline to 12 months regarding "Marginal adaptation" | alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin bravo: The general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does | baseline, 3-month, 6-month,12-month | |
Primary | Change from baseline to 12 months regarding "Surface roughness" | alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects | baseline, 3-month, 6-month,12-month | |
Primary | Change from baseline to 12 months regarding "Marginal staining" | alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin | baseline, 3-month, 6-month,12-month | |
Primary | Change from baseline to 12 months regarding "Retention" | alpha: intact bravo: chipped/loss of material charlie: complete loss of crown | baseline, 3-month, 6-month,12-month | |
Primary | Change from baseline to 12 months regarding "Incisal wear" | alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure | baseline, 3-month, 6-month,12-month |
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