The use of a premixed bioceramic material in the pulp cavity of decayed primary teeth in children
| ISRCTN | ISRCTN98720643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98720643 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CDRC FR0591 |
| Sponsor | King Saud University |
| Funder | Investigator initiated and funded |
- Submission date
- 07/09/2022
- Registration date
- 14/09/2022
- Last edited
- 11/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Deep tooth decay (dental caries) is very common among children. The most common treatment for deep caries in primary molars is pulpotomy, where the uppermost infected pulp inside the tooth is removed and replaced with a medicated filling. A variety of materials are used for pulpotomy including mineral trioxide aggregate (MTA). Newer materials are available in the dental market with better handling and easier application than MTA. NeoPUTTY is a premixed MTA that is being newly introduced for use in primary teeth pulpotomies. This study aims to compare the clinical and radiographic success rate of NeoPUTTy as a pulpotomy material in comparison to a conventional MTA.
Who can participate?
Healthy, cooperative children aged between 4 and 10 years old with one or more primary molars that have deep caries approaching the pulp
What does the study involve?
If the patient has one or more carious primary molars satisfying the inclusion criteria, after obtaining consent they will be enrolled in the study. Teeth will be randomly treated using one of the materials according to the randomization table. All teeth will receive a standardized pulpotomy treatment, then the tooth will be restored with a stainless steel crown. The included teeth will be evaluated clinically and radiographically after 6 and 12 months.
What are the possible benefits and risks of participating?
It is expected that participation in this study will help in enhancing the knowledge of pulp treatment in primary teeth. There are no known risks for the treatment provided. However, we cannot guarantee any unforeseeable risks. Immediate failed pulp therapy is rare but is associated with pain, swelling and/or tenderness when biting on the treated tooth. Long-term failure is mostly associated with a chronic abscess which according to the available data occurs in 5-10% of cases. Any side effect will receive immediate attention and proper treatment according to the standard of care for the condition will be provided.
Where is the study run from?
Dental University Hospital, King Saud University Medical City (Saudi Arabia)
When is the study starting and how long is it expected to run for?
January 2021 to September 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Abeer Alqahtani
abeer.sq@hotmail.com
Contact information
Principal investigator
Department of pediatric dentistry and orthodontics
College of dentistry
King Saud University
Riyadh
11515
Saudi Arabia
 ORCID ID |
0000-0002-5007-0870 |
|---|---|
| Phone | +966 553124390 |
| Aalqahtani3@ksu.edu.sa |
Principal investigator
Department of pediatric dentistry and orthodontics
College of dentistry
King Saud University
Riyadh
11515
Saudi Arabia
| Phone | +966 553124390 |
|---|---|
| abeer.sq@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized double-blind (participants and evaluators) single-center study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of premixed bioceramic material (NeoPUTTY®) as a pulpotomy material for primary molars: A randomized clinical trial |
| Study objectives | The null hypothesis is there is no significant difference in the clinical and radiographic success rates between NeoPUTTY® and NeoMTA2® as pulpotomy materials in primary molars |
| Ethics approval(s) | Approved 25/02/2021, The Institutional Review Board and Ethics Committee of the College of Dentistry Research Center (King Khalid Medical City, King Saud University, Riyadh, Saudi Arabia; +966 11 469 1532; rdeocampo@ksu.edu.sa), ref: E-21-5747 |
| Health condition(s) or problem(s) studied | Dental caries requiring pulpotomy treatment |
| Intervention | Children aged between 4 and 10 years old attending the pediatric dental clinics at Dental University Hospital, King Khaled Medical City, King Saud University will be screened for teeth with deep caries indicating pulpotomy treatment according to the study inclusion criteria. Consent was obtained parents/legal guardians. Included teeth were randomly divided into two groups (allocation ratio of 1:1): the control group (pulpotomy was performed with NeOMTA2) and the experimental group (pulpotomy performed using NeoPUTTY). Clinical and radiographic evaluations were conducted after 6 and 12 months by two blinded calibrated examiners. At each follow-up, the treatment was considered a clinical failure if one or more of the following signs and symptoms were present: pain, swelling, pathological mobility, sinus tract, and tenderness to percussion. Also, the treatment was considered a radiographic failure if one of the following signs were present: widening of the periodontal ligaments, internal or external root resorption, furcal and/or periapical radiolucency |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | NeoPUTTY®, NeoMTA2® |
| Primary outcome measure(s) |
Clinical and radiographic success rates of both pulpotomy materials measured using an assessment of signs and symptoms by the examiners at 6 and 12 months follow-up |
| Key secondary outcome measure(s) |
Failure type of each group measured by the examiners at 6 and 12 months follow-up |
| Completion date | 20/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Total final enrolment | 70 |
| Key inclusion criteria | 1. Children aged between 4 and 10 years old 2. Healthy (ASA Physical Status Classification System I and II) 3. Cooperative (positive or definitely positive behavior according to Frankl behavior scale) 4. Deep dentin caries approximating or reaching the pulp without any signs or symptoms of pulpal degeneration in one or more primary molar 5. Primary molars clinical inclusion criteria: no history of spontaneous or persistent pain; restorable primary molars with deep carious lesions approximating or reaching the pulp; no pathological mobility, no tenderness to percussion, no swelling or sinus tract; hemostasis achieved after coronal pulp amputation within 5 minutes 6. Primary molars radiographic inclusion criteria: deep dentin caries approximating or reaching the pulp; no more than two-thirds of physiologic root resorption; no widening of the periodontal ligament space; no pathologic internal or external root resorption; no apical or furcal radiolucency |
| Key exclusion criteria | 1. Children with special needs 2. Primary molars with uncontrolled bleeding after coronal pulp amputation |
| Date of first enrolment | 01/05/2021 |
| Date of final enrolment | 01/07/2021 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Riyadh
12372
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Abeer Alqahtani, abeer.sq@hotmail.com. SPSS data will be available, these data will become available upon request, written consent from participants was obtained, no ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/05/2023 | 11/07/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/07/2023: Publication reference added.
18/10/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 28/08/2022 to 20/09/2022.
2. The intention to publish date was changed from 01/10/2022 to 20/12/2022.
14/09/2022: Trial's existence confirmed by the Institutional Review Board and Ethics Committee of King Saud University.
