Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380296
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-15
Brief Title:
Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Clinical and Radiographic Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies baby root canal in children The main question it aims to answer is what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications NeoMTA and NeoPUTTY over a 24-month follow-up period Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study Pulpotomies baby root canal will be performed by trained dentists following a protocol Children will receive pulpotomies either with NeoMTA or NeoPUTTY two medications indicated for the procedure Participants will be asked to come for an appointment at 1 6 12 and 24 months after the procedure Researcher will compare the clinical and radiographic performance of pulpotomies baby root canal done with both medications
Detailed Description:
This single-site double-blinded participants and evaluators randomized clinical trial with parallel groups will be conducted at the Division of Dentistry Montreal Childrens Hospital Healthy children aged between 3 and 10 years undergoing dental rehabilitation under general anesthesia who have deep caries lesions approximating or reaching the pulp without any signs or symptoms of pulpal degeneration in one or more primary molars will be invited to participate in this study All participants will be randomly assigned 11 ratio into two groups i pulpotomy with NeoMTA and ii pulpotomy with NeoPutty Follow-up visits at 1 6 12 and 24 months will be conducted to assess the clinical and radiographic outcomes
The sample size calculation was done using GPower 3194 software Heinrich-Heine-Universität Düsseldorf Düsseldorf Germany In a recent study conducted by our research team the 24-month success rates of NeoMTA pulpotomy in primary molars was 98 manuscript in preparation for submission To account for a desired accuracy of 20 a significance level of 5 and a safety margin of 20 to compensate for patient dropouts a minimum sample size of 47 teeth in each group will be required
Trained clinical staff f will perform all primary molar pulpotomies following a standardized protocol doe each pulp medication used NeoMTA or NeoPUTTY
A baseline questionnaire will be filled by caregivers to assess childrens sociodemographic characteristics At each follow-up visit standardized clinical and radiographic will be performed by trained dentists
The post-operative clinical success will be considered as a retained tooth that is void of signs and symptoms of infection such as pain on percussion mobility presence of a fistula or an abscess Radiographic success will be determined by the lack of pathologic changes such as internal or external root resorption or a periradicular pathosis The extraction of the tooth due to signs and symptoms of infection will be considered as a failure
The sample size calculation was done using GPower 3194 software Heinrich-Heine-Universität Düsseldorf Düsseldorf Germany In a recent study conducted by our research team the 24-month success rates of NeoMTA pulpotomy in primary molars was 98 manuscript in preparation for submission To account for a desired accuracy of 20 a significance level of 5 and a safety margin of 20 to compensate for patient dropouts a minimum sample size of 47 teeth in each group will be required
Trained clinical staff f will perform all primary molar pulpotomies following a standardized protocol doe each pulp medication used NeoMTA or NeoPUTTY
A baseline questionnaire will be filled by caregivers to assess childrens sociodemographic characteristics At each follow-up visit standardized clinical and radiographic will be performed by trained dentists
The post-operative clinical success will be considered as a retained tooth that is void of signs and symptoms of infection such as pain on percussion mobility presence of a fistula or an abscess Radiographic success will be determined by the lack of pathologic changes such as internal or external root resorption or a periradicular pathosis The extraction of the tooth due to signs and symptoms of infection will be considered as a failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None