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
Secondary identifying numbers CDRC FR0591
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Abeer Alqahtani
Principal Investigator

Department of pediatric dentistry and orthodontics
College of dentistry
King Saud University
Riyadh
11515
Saudi Arabia

ORCiD logoORCID ID 0000-0002-5007-0870
Phone +966 553124390
Email Aalqahtani3@ksu.edu.sa
Dr Abeer Alqahtani
Principal Investigator

Department of pediatric dentistry and orthodontics
College of dentistry
King Saud University
Riyadh
11515
Saudi Arabia

Phone +966 553124390
Email abeer.sq@hotmail.com

Study information

Study designInterventional randomized double-blind (participants and evaluators) single-center study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleEvaluation of premixed bioceramic material (NeoPUTTY®) as a pulpotomy material for primary molars: A randomized clinical trial
Study objectivesThe 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) studiedDental caries requiring pulpotomy treatment
InterventionChildren 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)NeoPUTTY®, NeoMTA2®
Primary outcome measureClinical 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
Secondary outcome measuresFailure type of each group measured by the examiners at 6 and 12 months follow-up
Overall study start date07/01/2021
Completion date20/09/2022

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit10 Years
SexBoth
Target number of participants70 primary molars
Total final enrolment70
Key inclusion criteria1. 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 criteria1. Children with special needs
2. Primary molars with uncontrolled bleeding after coronal pulp amputation
Date of first enrolment01/05/2021
Date of final enrolment01/07/2021

Locations

Countries of recruitment

  • Saudi Arabia

Study participating centre

Dental University Hospital, King Saud University Medical City
P.O BOX 60169
Riyadh
12372
Saudi Arabia

Sponsor information

King Saud University
University/education

Department of pediatric dentistry and orthodontics
College of dentistry
Riyadh
11545
Saudi Arabia

Phone +966 11 469 1531
Email rdeocampo@ksu.edu.sa
Website https://ksu.edu.sa/en/
ROR logo "ROR" https://ror.org/02f81g417

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date20/12/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe 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

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.