Early Childhood CariesNCT05838469
Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors
A study testing Pediatric Strip Crown and High Viscosity Glass Ionomer Cement in people with Early Childhood Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Pediatric Strip Crown and High Viscosity Glass Ionomer Cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2022to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Early Childhood Caries
- Being tested
- Pediatric Strip Crown and High Viscosity Glass Ionomer Cement
- Keywords
- high viscosity glass ionomer cement, strip crown, pediatric dentistry, child, early childhood caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Strip Crown and High Viscosity Glass Ionomer CementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Strip Crown | Experimental | This is a single-arm study. High viscosity glass ionomer strip crowns will be performed to all patients. Receives: Other: Pediatric Strip Crown and High Viscosity Glass Ionomer Cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 3-month, 6-month,12-month
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
Measured: baseline, 3-month, 6-month,12-month
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
Measured: baseline, 3-month, 6-month,12-month
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
Measured: baseline, 3-month, 6-month,12-month
Change from baseline to 12 months regarding "Retention"
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Measured: baseline, 3-month, 6-month,12-month
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
Measured: baseline, 3-month, 6-month,12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start2 Aug 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beste Ozgur, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838469
- Sponsor's protocol ID
- HUDHF-StripCrown
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waggoner WF. Restoring primary anterior teeth: updated for 2014. Pediatr Dent. 2015 Mar-Apr;37(2):163-70.
PubMed 25905657Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options. Pediatr Dent. 2016 Oct;38(6):55-56. No abstract available.
PubMed 27931421Policy on Interim Therapeutic Restorations (ITR). Pediatr Dent. 2018 Oct 15;40(6):58-59. No abstract available.
PubMed 32074851Friedl 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.
PubMed 21840585
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors
- ClinicalTrials.gov ID
- NCT05838469
- Acronym / sponsor ID
- HUDHF-StripCrown
- Conditions
- Early Childhood Caries
- Keywords
- high viscosity glass ionomer cement, strip crown, pediatric dentistry, child, early childhood caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strip Crown | Experimental | Other: Pediatric Strip Crown and High Viscosity Glass Ionomer CementThis is a single-arm study. High viscosity glass ionomer strip crowns will be performed to all patients. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Strip Crown and High Viscosity Glass Ionomer CementFollowing 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. | Other | Strip Crown |
Primary outcome
Change from baseline to 12 months regarding "Anatomic form"
Time frame: 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
Change from baseline to 12 months regarding "Marginal adaptation"
Time frame: 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
Change from baseline to 12 months regarding "Surface roughness"
Time frame: 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
Change from baseline to 12 months regarding "Marginal staining"
Time frame: 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
Change from baseline to 12 months regarding "Retention"
Time frame: baseline, 3-month, 6-month,12-month
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Change from baseline to 12 months regarding "Incisal wear"
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Background: PubMed 25905657Waggoner WF. Restoring primary anterior teeth: updated for 2014. Pediatr Dent. 2015 Mar-Apr;37(2):163-70.
- Background: PubMed 27931421Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options. Pediatr Dent. 2016 Oct;38(6):55-56. No abstract available.
- Background: PubMed 32074851Policy on Interim Therapeutic Restorations (ITR). Pediatr Dent. 2018 Oct 15;40(6):58-59. No abstract available.
- Background: PubMed 21840585Friedl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Strip Crown and High Viscosity Glass Ionomer Cement in people with Early Childhood Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 12 months regarding "Anatomic form" (time frame: baseline, 3-month, 6-month,12-month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838469, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.