UnknownNot Applicable

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

Turkey (Türkiye)100 participantsStarted 2022-08-02

Plain-language 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.

Who can participate

Age range

2 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline to 12 months regarding "Anatomic form"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Marginal adaptation"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Surface roughness"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Marginal staining"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Retention"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Incisal wear"

Timeframe: baseline, 3-month, 6-month,12-month

Trial details

NCT IDNCT05838469

SponsorHacettepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08

View on ClinicalTrials.gov More Early Childhood Caries trials

Who can participate

Age range

2 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline to 12 months regarding "Anatomic form"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Marginal adaptation"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Surface roughness"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Marginal staining"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Retention"

Timeframe: baseline, 3-month, 6-month,12-month

Change from baseline to 12 months regarding "Incisal wear"

Timeframe: baseline, 3-month, 6-month,12-month