Not Yet RecruitingNot Applicable

Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children

Saudi Arabia120 participantsStarted 2026-05

Plain-language summary

The goal of this clinical trial is to compare the long-term clinical performance of three different luting cements used to bond prefabricated zirconia crowns (PZCs) on primary front teeth in young children. The trial will determine whether any single cement offers superior retention, gum health, or marginal sealing compared to the others over a 3-year period. Main Questions: The study aims to answer the following: Are conventional glass ionomer cement (GIC), bioactive resin-modified glass ionomer cement (BioCem™), and self-adhesive resin cement (SARC) equivalent in retaining prefabricated zirconia crowns on primary incisors over 36 months? Do these cements differ in their effect on gingival health, plaque accumulation, or marginal discoloration around the cemented crown? Comparison: Researchers will compare three parallel groups of children whose primary incisors are restored with identical prefabricated zirconia crowns but cemented with one of the three different luting cements. Participants will: Receive a clinical and radiographic dental examination at screening. Undergo placement of one or more prefabricated zirconia crowns on primary anterior teeth using their randomly assigned cement. Return to the clinic for blinded follow-up evaluations at 12, 24, and 36 months for assessment of crown retention, gingival health, plaque, and marginal staining.

Who can participate

Age range

2 Years – 7 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

. Healthy children aged 2 to 7 years
. One or more primary maxillary or mandibular incisors requiring full-coverage restoration due to caries or trauma
. Adequate remaining tooth structure following preparation, defined as greater than 50% of the clinical crown
. Parent or legal guardian able and willing to provide written informed consent and to commit to the 36-month follow-up schedule

Exclusion criteria

. Active periodontal disease at the index tooth, defined as a Löe Gingival Index score of 2 or higher
. Parafunctional habits such as bruxism, severe thumb-sucking, or tongue-thrust documented at screening

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

Crown Retention (Survival)

Timeframe: Baseline, 12, 24, and 36 months post-cementation

Trial details

NCT IDNCT07611734

SponsorMurad Alrashidi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06

Contact for this trial

MURAD ALRASHIDI, BDS, MSC

+966 55 302 2773 MU.ALRASHIDI@qu.edu.sa

View on ClinicalTrials.gov More Dental Caries trials