Comparing the performance of two types of aesthetic crowns for children's primary teeth
| ISRCTN | ISRCTN52747143 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52747143 |
| Secondary identifying numbers | UDDS-1157-30122024/SRC-1550 |
- Submission date
- 13/05/2025
- Registration date
- 27/05/2025
- Last edited
- 27/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aim
This study aims to evaluate the clinical performance of different types of prefabricated crowns used to restore second primary molars after pulpotomy (a common procedure to treat infected dental pulp in children). The crowns being studied include BioFlx, Zirconia, and stainless steel crowns with silver and gold coloring. The goal is to assess how well these crowns protect the treated teeth, maintain function.
Who can participate?
Children aged 6 to 10 years who need full-coverage restoration after pulpotomy, have good oral hygiene, and are cooperative during dental treatment may be eligible to participate. Written informed consent from parents or guardians is required.
What does the study involve?
Children will receive a pulpotomy on one or more second primary molars. The treated tooth will then be restored with one of the study crowns. Follow-up appointments will take place at 1, 6, and 12 months after treatment to check the crown's fit and oral health.
What are the possible benefits and risks of participating?
Benefits:
The child will receive a high-quality, full-coverage restoration.
Regular follow-up may help detect and manage any issues early.
The findings may help improve future pediatric dental care.
Risks:
Minor discomfort during treatment or follow-up.
Possible failure of the crown, requiring further dental treatment.
Where is the study run from?
Department of Pediatric Dentistry, Faculty of Dentistry, University of Damascus, Syria
Who is funding the study?
This study is self-funded by the principal investigator and supported by the Faculty of Dentistry, University of Damascus.
Who is the main contact?
Ahmad Taleb; ahmed.taleb1195@gmail.com
Mohamed Altinawi; mohamedaltinawi@gmail.com
Contact information
Public, Principal Investigator
Damascus University
Mazzeh
Damascus
00000
Syria
| Phone | +963 938466353 |
|---|---|
| ahmed.taleb1195@gmail.com |
Scientific
Damascus University
Mazzeh
Damascus
00000
Syria
| Phone | +963 938476466 |
|---|---|
| mohamedaltinwi@gmail.com |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Efficacy |
| Participant information sheet | 47331_PIS.pdf |
| Scientific title | Evaluation of the clinical performance of two types of prefabricated aesthetic crowns in the restoration of primary molars: a randomized controlled trial |
| Study acronym | PEARP |
| Study objectives | This study is based on the following null hypotheses: Marginal Adaptation: There is no difference between prefabricated aesthetic crowns (BioFlx and Zirconia) and stainless-steel crowns (silver and gold colored) in terms of marginal adaptation on primary molars. Gingival Health: There is no difference between prefabricated aesthetic crowns (BioFlx and Zirconia) and stainless-steel crowns (silver and gold colored) regarding their impact on gingival health. Dental Arch Length: There is no statistically significant difference between prefabricated aesthetic crowns (BioFlx and Zirconia) and stainless-steel crowns (silver and gold colored) in their influence on dental arch length maintenance. |
| Ethics approval(s) |
Approved 30/12/2024, Biomedical Research Ethics Committee of Damascus University (University Presidency Building, University Campus, Baramkeh 23J89, Damascus, 00000, Syria; +963 1133923012; president@damasuniv.edu.sy), ref: 1157 |
| Health condition(s) or problem(s) studied | Extensively decayed second primary molars requiring pulpotomy and full coronal restoration |
| Intervention | Participants were randomly assigned to one of four study groups using computer-generated block randomisation (block size = 8). An independent researcher generated the sequence and prepared sealed, opaque envelopes to ensure allocation concealment. Envelopes were opened only after participant eligibility was confirmed. Following participant inclusion, baseline clinical parameters will be recorded by the examiner, including the Oral Hygiene Index-Simplified (OHIS), Gingival Index (GI), Plaque Index (PI), Bleeding on Probing (BOP), and assessment of contact points. Local anesthesia will be administered prior to tooth preparation. Primary molars allocated to receive BioFlx (Experimental), Gold stainless steel (Experimental), and silver stainless steel (Control) will be prepared using the following protocol: Occlusal reduction of 1–1.5 mm Axial reduction of 20–30% using a tapered bur Rounding of axial walls Trial fitting to ensure occlusal accuracy Final cementation with Fuji I glass ionomer cement Occlusal adjustment as needed Primary molars allocated to receive Zirconia Crowns (Experimental) will be prepared using the following protocol: Occlusal surface reduction of 1–2 mm using a flame-shaped bur Opening of interproximal areas Axial reduction of 20–30% (approximately 0.5–1.25 mm), maintaining a natural tooth contour Finishing of all tooth walls with a subgingival margin (1–2 mm) Occlusal adjustment as needed All procedures will be performed under rubber dam isolation when feasible and in accordance with the manufacturers' recommendations. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The following primary clinical and photographic evaluations are carried out at 1, 6, and 12 months: 1. Oral Hygiene Index-Simplified (OHIS), defined as 0 = No debris; 3 = Debris > 2/3 of surface. Interpretation: 0–1 = Good, 1–2 = Fair, 2–3 = Poor 2. Plaque Index (PI), defined as 0 = absence of plaque, 1= Thin film of plaque, 2= moderate accumulation of plaque 3 = Large amount of Plaque 3. Gingival Index (GI), defined as 0 = Normal, 1= mild inflammation, 2= moderate inflammation 3 = Severe inflammation 4. Bleeding on Probing (BOP), defined as (-) = No bleeding, (+) = Bleeding after probing 5. Marginal integrity, defined as 0 = No gap, 2 = Visible gap |
| Secondary outcome measures | Contact points (0 = Normal, 2 = Open), Crown fracture (0 = Intact, 1 = Minor chipping, 2 = Cracks, 3 = Full fracture), measured using clinical and photographic evaluations to the United States Public Health Service (USPHS) Criteria at 1, 6, and 12 months |
| Overall study start date | 30/12/2024 |
| Completion date | 01/10/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Age 6–10 years 2. Good/acceptable oral hygiene 3. Positive or definitely positive Frankl behavior rating 4. Indication for full-coverage restoration (endodontically treated teeth) 5. Absence of mobility or sinus tract 6. Healthy child (no systemic illness or medication-induced gingival overgrowth) 7. Normal occlusion, no bruxism 8. Presence of opposing and adjacent teeth 9. Signed informed consent and commitment to follow-ups |
| Key exclusion criteria | 1. Poor oral hygiene or presence of uncontrolled plaque or gingivitis 2. Uncooperative behavior, defined as negative or definitely negative on the Frankl behavior rating scale 3. Children with systemic illnesses or conditions that may affect gingival health (e.g., medication-induced gingival overgrowth) |
| Date of first enrolment | 01/05/2025 |
| Date of final enrolment | 15/07/2025 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
00000
Syria
Sponsor information
University/education
Baramkeh
Damascus
0000
Syria
| Phone | +963 1133923012 |
|---|---|
| president@damasuniv.edu.sy | |
| Website | https://www.damascusuniversity.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/10/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Ahmad Taleb; ahmed.taleb1195@gmail.com Data Availability: IPD will be made available to researchers after the study’s final publication in a de-identified format to protect participant privacy. Access: Researchers can request access to the data by submitting a research proposal for review by the study's ethics or data access committee. Timeline: Data will be shared within [6 months] after the study’s final publication. Security: Data will be anonymized and stored in secure, password-protected databases with access restricted to authorized personnel. Ethics and Consent: Participants have given consent for their de-identified data to be used for future research. Data sharing will comply with the study’s ethical guidelines. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 27/05/2025 | No | Yes |
Additional files
Editorial Notes
14/05/2025: Study's existence confirmed by the Biomedical Research Ethics Committee of Damascus University.
