Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05838469
Other study ID # HUDHF-StripCrown
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 2, 2022
Est. completion date August 2024

Study information

Verified date April 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Following the decision on the appropriate size of celluloid strip crown, the tooth will be isolated using roll cottons and the "cavity conditioner" (GC, Japan) will be applied to all surfaces for 10 seconds, washed away and dried with cotton pellets. The selected celluloid strip crown will be filled with a fluoride-releasing bulk fill hybrid glass ionomer cement (EQUIA Forte, GC, Japan) prepared by mixing for 10 seconds in an automatic mixer and placed on the tooth with light pressure. The excess material on the crown margins will be removed with a hand instrument, and the celluloid strip crown will be removed from the tooth. If necessary, the restoration will be polished using a polishing discs. After the crown surface is washed and dried, a nano-filled surface sealant (EQUIA Forte Coat, GC, Tokyo, Japan) will be applied for 10 seconds with a micro-tipped applicator and light cured for 20 seconds. Clinical evaluations will be done at the 3rd, 6th and 12th months.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pediatric Strip Crown and High Viscosity Glass Ionomer Cement
Following the decision on the appropriate size of celluloid strip crown, the tooth will be isolated using roll cottons and the "cavity conditioner" (GC, Japan) will be applied to all surfaces for 10 seconds, washed away and dried with cotton pellets. The selected celluloid strip crown will be filled with a fluoride-releasing bulk fill hybrid glass ionomer cement (EQUIA Forte, GC, Japan) prepared by mixing for 10 seconds in an automatic mixer and placed on the tooth with light pressure. The excess material on the crown margins will be removed with a hand instrument, and the celluloid strip crown will be removed from the tooth. If necessary, the restoration will be polished using a polishing discs. After the crown surface is washed and dried, a nano-filled surface sealant (EQUIA Forte Coat, GC, Tokyo, Japan) will be applied for 10 seconds with a micro-tipped applicator and light cured for 20 seconds.

Locations

Country Name City State
Turkey Hacettepe University Ankara Altindag

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT02019160 - Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish Phase 3
Recruiting NCT05272254 - Povidone Iodine Efficacy Study Phase 2
Not yet recruiting NCT05370989 - Technology-Based Parent School Program N/A
Recruiting NCT04665219 - HBM for Empowering Parental Toothbrushing and Sugar Intake Control N/A
Not yet recruiting NCT04003129 - Knowledge, Practice and Attitude of Paediatricians Regarding Early Childhood Caries
Completed NCT03423797 - The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children Phase 3
Completed NCT03693443 - Knowledge and Behavior Toward Early Childhood Caries
Completed NCT04655430 - Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Childre Phase 2/Phase 3
Completed NCT05515510 - Acceptance and Efficacy of a Digital Application Among Parents to Control Early Childhood Caries N/A
Completed NCT04054635 - A Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children N/A
Recruiting NCT05260216 - Clinical Analysis of a Risk-graded and Comprehensive Intervention for Early-childhood-caries N/A
Completed NCT03625310 - Effectiveness Fluoride Varnishes in Children With Early Childhood Caries N/A
Completed NCT05748054 - Early Childhood Caries in Jordanian Children N/A
Not yet recruiting NCT04737057 - Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar: N/A
Completed NCT03162822 - Caregiver-Child Interaction and Health Behaviors N/A
Completed NCT04456335 - Investigation of Supragingival Plaque Microbiome in Early Childhood Caries
Recruiting NCT05352841 - Leptin, Adiponectin, FRAP and Tac in Patients With Early Childhood Caries
Terminated NCT04556175 - Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project N/A
Completed NCT05761041 - Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries Phase 3
Completed NCT03360266 - Evaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC Children N/A