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The effect of cement material on performance of Zirconia dental crowns in children

Clinical evaluation of pediatric Zirconia crowns cemented with two luting cements: a split-mouth randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11721871
Enrollment
25
Registered
2021-02-19
Start date
2021-06-01
Completion date
Unknown
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Two or more carious primary maxillary incisors that require full coverage with Zirconia crowns. Oral Health

Interventions

This is a split-mouth randomized clinical trial involving 25 three- to six-year-old children with a total of 25 pairs of maxillary incisors requiring primary zirconia crowns. All potential participa

Sponsors

Jordan University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 3 - 6 years with at least two or more carious primary maxillary incisors that require full coverage with Zirconia crowns. Indications for zirconia crowns: 1.1. Multiple surface caries 1.2. Large single surface caries 1.3. Involvement of incisal edge 1.4. Minor caries but high-risk pt 1.5. Following pulp therapy 2. ASA I and ASA II who will receive treatment under general anesthesia 3. Patients available for recalls as outlined in the study protocol

Exclusion criteria

Exclusion criteria: 1. Patient is ASA III or higher 2. Incisors with multiple hypoplastic defects or developmental disturbances 3. Carious primary incisors that are not indicated for zirconia crowns: 3.1. Incisors with root/subgingival caries 3.2. Incisors with very little tooth structure that is inadequate for crown retention , i.e. unrestorable 3.3. Incisors with signs or symptoms of extensive pathology such as mobility grade II or more, internal resorption or excessive external root resorption involving more than one-third of the root, or with significant inter radicular/periapical radiolucency (root and inter radicular/periapical area will be assessed based on a preoperative radiographic examination (with periapical or anterior occlusal radiograph) in cooperative patients) 3.4. Incisors that are expected to exfoliate in 6 - 12 months 4. Patients that show signs of severe bruxism or teeth clenching

Design outcomes

Primary

MeasureTime frame
Crowns retention will be checked by gently probing around the crown at 1 week, 1-, 3-, 6- , 12- and 24-months by the dental surgeon

Secondary

MeasureTime frame
Gingival health will be measured using the gingival index at 1 week, 1-, 3-, 6- , 12- and 24-months by the dental surgeon

Countries

Jordan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026