Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors

Sponsor
Hacettepe University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05838469
Collaborator
(none)
100
1
1
24
4.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pediatric Strip Crown and High Viscosity Glass Ionomer Cement
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors
Actual Study Start Date :
Aug 2, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Strip Crown

This is a single-arm study. High viscosity glass ionomer strip crowns will be performed to all patients.

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline to 12 months regarding "Anatomic form" [baseline, 3-month, 6-month,12-month]

    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

  2. Change from baseline to 12 months regarding "Marginal adaptation" [baseline, 3-month, 6-month,12-month]

    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

  3. Change from baseline to 12 months regarding "Surface roughness" [baseline, 3-month, 6-month,12-month]

    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

  4. Change from baseline to 12 months regarding "Marginal staining" [baseline, 3-month, 6-month,12-month]

    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

  5. Change from baseline to 12 months regarding "Retention" [baseline, 3-month, 6-month,12-month]

    alpha: intact bravo: chipped/loss of material charlie: complete loss of crown

  6. Change from baseline to 12 months regarding "Incisal wear" [baseline, 3-month, 6-month,12-month]

    alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Altındağ Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Beste Ozgur, assistant professor, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05838469
Other Study ID Numbers:
  • HUDHF-StripCrown
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beste Ozgur, assistant professor, Hacettepe University

Study Results

No Results Posted as of May 1, 2023