Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Starting soon · Not applicable
Conditions studied: Dental Caries, Tooth Injuries, Primary Tooth Restoration
In brief
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.
Key facts
- Study ID
- NCT07611734
- Run by
- Murad Alrashidi
- People needed
- 120
- Starts
- 2026-05-01
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 2 and older, up to 7. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Known allergy or hypersensitivity to zirconia, resin, glass ionomer, or any component of the assigned cement
- Inconsistent oral hygiene, defined as less than twice-daily toothbrushing per parental report
- Systemic disease affecting bone metabolism, tooth development, or wound healing
- Current participation in another interventional dental clinical trial
Where it is running
- Qassim University — Buraidah, Al-Qassim Region, Saudi Arabia
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.