The effect of cement material on performance of Zirconia dental crowns in children
| ISRCTN | ISRCTN11721871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11721871 |
| Secondary identifying numbers | 70-2020 |
- Submission date
- 09/01/2021
- Registration date
- 19/02/2021
- Last edited
- 30/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Early childhood tooth decay is a significant public health problem with consequences on both oral and general health. Maintaining healthy teeth in children is important for the child’s overall health and well being. Several treatment options have been proposed for restoring carious (decayed) primary (baby) teeth in children. Recently, Zirconia crowns have been introduced as a realistic and good looking option. Despite the increasing use of these crowns, there are only a few clinical trials assessing the clinical outcomes and the survival of these crowns. One of the aspects that have been scarcely investigated in the clinical settings is the type of cement used to secure these crowns.
Who can participate?
Children (age 3-6 years) with at least two upper incisors that require full coverage with Zirconia crowns, and who are otherwise medically healthy or having mild medical illness.
What does the study involve?
Pair-matched incisors will be randomly assigned to receive a type of cement material (either Bio-active cement or Glass Ionomer cement) for crown cementation.
The crowns will be clinically evaluated for retention, and gingival (gum) condition at 1 week, 1 -,3-, 6- , 12- and 24-month follow up appointments.
What are the possible benefits and risks of participating?
Children are expected to benefit from the provision of Zirconia crowns for the treatment of their decayed front teeth. In addition to treating decay, these crowns restore esthetics and function. Zirconia crowns are safe and biocompatible. Regular checkups will be scheduled to participants as part of the study.
There are no particular potential risks associated with the provision of these crowns. If the treatment is going to be provided under general anesthesia (i.e. if the child is going to be put to sleep to get this treatment done), then any potential risks will be discussed/explained by the anesthetist.
Where is the study run from?
Jordan University of Science and Technology
When is the study starting and how long is it expected to run for?
February 2020 to June 2026
Who is funding the study?
Jordan University of Science and Technology
Who is the main contact?
Dr Thikrayat Bani-Hani, tgbanihani@just.edu.jo
Contact information
Scientific
Jordan University of Science and Technology
Ar Ramtha 3030
Irbid
112200
Jordan
 ORCID ID |
0000-0002-0429-8786 |
|---|---|
| Phone | +962 791496395 |
| tgbanihani@just.edu.jo |
Study information
| Study design | Split-mouth randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Clinical evaluation of pediatric Zirconia crowns cemented with two luting cements: a split-mouth randomized controlled trial |
| Study objectives | The study seeks to compare the efficacy of using bio-active cement versus glass ionomer cement with anterior zirconia crowns. |
| Ethics approval(s) | Approved 31/03/2020, JUST (Jordan University of Science and Technology) Institutional Research Board (IRB) (Ar Ramtha 3030, Irbid, 112200, Jordan; +962 7200600, ext 450102; irb@just.edu.jo), ref: 70-2020 |
| Health condition(s) or problem(s) studied | Two or more carious primary maxillary incisors that require full coverage with Zirconia crowns. |
| Intervention | 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 participants will be examined by the principal investigator for their treatment needs. Only those who require comprehensive oral treatment under General Anesthesia (GA) will be involved in the study to ensure symmetrical preparations and eliminate any potential influences due to behavioral/cooperation factors.. According to the AAPD, and excluding patients with physical or mental disability and patients with acute infections for the purpose of the current study, the following are the criteria for listing patients for dental treatment under GA: 1. Patients who are extremely uncooperative, fearful, anxious, or uncommunicative 2. Patients who require significant surgical procedures or immediate, comprehensive oral/dental care Dental treatment will be provided under general anesthesia at King Abdullah University Hospital (KAUH). All teeth will be restored by one dentist who is trained in tooth preparation for zirconia crowns. Local anesthesia and rubber dam isolation will be used whenever applicable. Each participant will receive a minimum of two and a maximum of four Zirconia crowns according to each case needs. Pair-matched incisors will be randomly assigned to receive either bio-active cement or glass ionomer cement for crown cementation. Randomisation is going to be computer-generated using Excel. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | Gingival health will be measured using the gingival index at 1 week, 1-, 3-, 6- , 12- and 24-months by the dental surgeon |
| Overall study start date | 01/02/2020 |
| Completion date | 01/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 01/06/2025 |
Locations
Countries of recruitment
- Jordan
Study participating centre
Irbid
112200
Jordan
Sponsor information
University/education
Ar Ramtha 3030
Irbid
112200
Jordan
| Phone | +962 27201000 |
|---|---|
| research@just.edu.jo | |
| Website | http://www.just.edu.jo/Pages/Default.aspx |
"ROR" |
https://ror.org/03y8mtb59 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- جامعة العلوم والتكنولوجيا الأردنية, JUST
- Location
- Jordan
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
30/06/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2023 to 01/06/2025.
2. The overall end date was changed from 01/06/2024 to 01/06/2026.
3. The intention to publish date was changed from 01/06/2025 to 01/06/2027.
4. The plain English summary was updated to reflect these changes.
17/02/2023: The recruitment end date was changed from 01/06/2022 to 01/06/2023.
20/01/2021: Trial’s existence confirmed by Jordan University of Science and Technology.
