CompletedNot Applicable

CLINICAL PERFORMANCE OF PEDIATRIC CROWNS IN PRIMARY MOLAR

Turkey (Türkiye)46 participantsStarted 2025-01-11

Plain-language summary

The aim of this study is to compare the clinical success of three different types of prefabricated crowns commonly used in primary molar teeth: nanohybrid composite crowns, zirconia crowns, and stainless steel crowns. Primary molar teeth play a critical role in supporting growth and development by facilitating mastication and nutrition and by maintaining space for the eruption of permanent successor teeth. Current guidelines in pediatric dentistry recommend stainless steel crowns for the restoration of primary molars with extensive carious lesions. However, increasing esthetic demands have led to the development and growing use of alternative crown systems, such as zirconia and nanohybrid composite crowns. This study will be conducted on 50 children aged 4 to 9 years who present to the Department of Pediatric Dentistry at Izmir Katip Celebi University Faculty of Dentistry, have no systemic diseases, and have no known allergies to local anesthetic agents. Children presenting with carious lesions affecting both mandibular second primary molars will be included. Clinically, teeth with International Caries Detection and Assessment System (ICDAS II) scores of 4, 5, and 6 will be eligible. Radiographically, lesions classified as D1-RA3, D2-RB4, and D3-RC5 will be included. The study will be designed as a randomized, controlled, parallel-group clinical trial. Participants will be randomly allocated into two groups: in one group, prefabricated zirconia crowns and stainless steel crowns will be placed, while in the other group, nanohybrid composite crowns and stainless steel crowns will be applied. The primary outcome of the study is to evaluate and compare the clinical success of the three crown types at 3, 6, 9, and 12 months following treatment based on functional, esthetic, and biological criteria. Functional outcomes will include crown retention and material loss, marginal adaptation, antagonist tooth wear, and occlusal height of the crown. Esthetic outcomes will be assessed in terms of surface roughness, color match, and anatomical form. Biological outcomes will include periodontal health. As a secondary outcome, parental satisfaction will be evaluated to assess perceptions of treatment success and factors influencing crown preference. The results of this study are expected to provide valuable clinical evidence to guide the selection of the most appropriate prefabricated crown type for primary molars in pediatric dentistry.

Who can participate

Age range

4 Years – 9 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: * Children aged 4 to 9 years with no systemic diseases (ASA I). * Cooperative behavior assessed as Frankl Score 3 (Positive) or 4 (Definitely Positive). * Written informed consent obtained from the parent/legal guardian and assent from the child. * Willingness to attend all scheduled follow-up visits. * Presence of bilateral mandibular second primary molars (teeth 75 and 85) with multisurface carious lesions. * Presence of an opposing antagonist tooth in occlusion. * Carious lesions classified as ICDAS II Score 4, 5, or 6. * Radiographic caries depth extending to D1-RA3, D2-RB4, or D3-RC5. * Root resorption not exceeding one-third of the root length. * No radiographic evidence of periapical or furcation radiolucency. * Normal periodontal ligament space and intact lamina dura. * No evidence of internal or external root resorption. Exclusion Criteria: * Children classified as ASA II or higher or having systemic diseases. * Frankl Behavior Rating Scale Score 1 or 2. * Unwillingness to attend follow-up visits or provide informed consent. * Presence of temporomandibular joint disorders. * Presence of parafunctional habits such as bruxism. * Absence of one or both mandibular second primary molars. * Absence of an opposing antagonist tooth. * Carious lesions classified as ICDAS II Score 1, 2, or 3. * Radiographic findings limited to enamel caries or no evidence of caries (E0-R0, E1-RA1, E2-RA2).

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

Clinical Success of Prefabricated Crowns Based on FDI Criteria

Timeframe: 3, 6, 9, and 12 months after crown placement

Trial details

NCT IDNCT07426445

SponsorIzmir Katip Celebi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-11

View on ClinicalTrials.gov More Dental Caries in Primary Teeth trials