Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288477
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-23
Brief Title:
Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA Neo-putty as a Novel Pulpotomy Medication Versus Formocresol
Sponsor:
October University for Modern Sciences and Arts
Organization:
October University for Modern Sciences and Arts
Study Overview
Official Title:
Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA Neo-putty as a Novel Pulpotomy Medication Versus Formocresol A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Despite the benefit of formocresol there are toxic effects allergic reactions and local soft and hard tissue necrosis have been reported when such formaldehyde compounds were used clinically however the adverse effect of the clinically used of this compound are not widely reported It has been stated that it has a side effect on the permanent successor although it results as a successful technique for the treatment of the primary teeth
Detailed Description:
The rationale for conducting the research
Nowadays the introduction of new Bio-inductive materials resulted in the shift of the concept of preservation of radicular pulp tissue to regeneration Restoration of the anatomical continuity of damaged tissue and disturbed functional status of the radicular pulp tissue require an appropriate method of wound healing which includes well-organized biochemical and cellular events leading to the growth and regeneration of injured radicular tissue in a special manner
A higher standard in bioactive bioceramic putty as manufacture claimed the Neo-Putty NuSmile is a bioactive bioceramic premixed root and pulp treatment with superior handling properties promoting hydroxyapatite formation to support the healing process Neo-Putty is a premixed bioactive bioceramic root pulp treatment consisting of an extremely fine inorganic powder of tricalciumdicalcium silicate in a water free organic liquid The product is packaged ready to use No mixing is required Neo-Putty is designed to set in vivo in the presence of moisture from the surrounding tissues Considering the limitations of these data we are conduction this clinical trial The outcomes of this study will have a substantial impact on clinical practice for pediatric patients as well as patient care around the world
Aim of the study
This randomized clinical trial study will assess clinically and radiographically the effect of Neo-Putty as a pulp medicament following coronal pulp amputation in childrens primary molars with carious pulp exposure in comparison to Formocresol FC
Research question
Is the pulpotomy procedure in primary molars using premixed Bioactive bioceramic MTA Neo-putty more clinically successful than Formocresol
PICOS
P Carious primary molars with no spontaneous or provoked pain vital primary molars I Neo-Putty as dressing agents in pulpotomized primary molars C Formocresol Pulpotomy FC O Clinical Success S In-Vivo Study II Methods
Study Design
Study Type Interventional Clinical Trial Estimated Enrolment 88 participants Allocation Randomized Intervention Model Parallel Assignment Primary Purpose Treatment Official Title Clinical and Radiographic Evaluation of Vital Pulpotomy in Primary Molars using of premixed Bioactive bioceramic MTA Neo-putty as a Novel Pulpotomy Medication versus Formocresol A Randomized Clinical Trial Estimated Study Start Date December 2023 Estimated Primary Completion Date January 2024
Trial design
The study is a randomized clinical trial RCT where 2 arm parallel groups with a 11 allocation ratio were compared The child participants and the legal guardian of each participating child and the statistician were blinded
Interventions In the control group a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp after reaching hemostasis The pulp stumps will be then covered by IRM
In the Intervention group
Neo-Putty as dressing agents in pulpotomized primary molars Following removal of the coronal pulp with a round bur and hemostasis the pulp stumps in the study group will be covered with Neo-Putty according to the manufacturers instructions Neo-Putty will be placed in the prepared cavity and then covered with a reinforced Zinc Oxide-Eugenol IRM Bayer-Leverkussen Germany
Outcome Measures
1 Primary outcome Clinical success Time Frame 12 months
Success clinically and radiographically will assess by the number of participants with symptoms-free and no peri-radicular pathology at 369and 12 months
No clinical or radiographic evidence of pulp degeneration such as spontaneous pain excessive bleeding from the root canal internal root resorption inter-radicular andor periapical bone destruction swelling or sinus tract
Nowadays the introduction of new Bio-inductive materials resulted in the shift of the concept of preservation of radicular pulp tissue to regeneration Restoration of the anatomical continuity of damaged tissue and disturbed functional status of the radicular pulp tissue require an appropriate method of wound healing which includes well-organized biochemical and cellular events leading to the growth and regeneration of injured radicular tissue in a special manner
A higher standard in bioactive bioceramic putty as manufacture claimed the Neo-Putty NuSmile is a bioactive bioceramic premixed root and pulp treatment with superior handling properties promoting hydroxyapatite formation to support the healing process Neo-Putty is a premixed bioactive bioceramic root pulp treatment consisting of an extremely fine inorganic powder of tricalciumdicalcium silicate in a water free organic liquid The product is packaged ready to use No mixing is required Neo-Putty is designed to set in vivo in the presence of moisture from the surrounding tissues Considering the limitations of these data we are conduction this clinical trial The outcomes of this study will have a substantial impact on clinical practice for pediatric patients as well as patient care around the world
Aim of the study
This randomized clinical trial study will assess clinically and radiographically the effect of Neo-Putty as a pulp medicament following coronal pulp amputation in childrens primary molars with carious pulp exposure in comparison to Formocresol FC
Research question
Is the pulpotomy procedure in primary molars using premixed Bioactive bioceramic MTA Neo-putty more clinically successful than Formocresol
PICOS
P Carious primary molars with no spontaneous or provoked pain vital primary molars I Neo-Putty as dressing agents in pulpotomized primary molars C Formocresol Pulpotomy FC O Clinical Success S In-Vivo Study II Methods
Study Design
Study Type Interventional Clinical Trial Estimated Enrolment 88 participants Allocation Randomized Intervention Model Parallel Assignment Primary Purpose Treatment Official Title Clinical and Radiographic Evaluation of Vital Pulpotomy in Primary Molars using of premixed Bioactive bioceramic MTA Neo-putty as a Novel Pulpotomy Medication versus Formocresol A Randomized Clinical Trial Estimated Study Start Date December 2023 Estimated Primary Completion Date January 2024
Trial design
The study is a randomized clinical trial RCT where 2 arm parallel groups with a 11 allocation ratio were compared The child participants and the legal guardian of each participating child and the statistician were blinded
Interventions In the control group a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp after reaching hemostasis The pulp stumps will be then covered by IRM
In the Intervention group
Neo-Putty as dressing agents in pulpotomized primary molars Following removal of the coronal pulp with a round bur and hemostasis the pulp stumps in the study group will be covered with Neo-Putty according to the manufacturers instructions Neo-Putty will be placed in the prepared cavity and then covered with a reinforced Zinc Oxide-Eugenol IRM Bayer-Leverkussen Germany
Outcome Measures
1 Primary outcome Clinical success Time Frame 12 months
Success clinically and radiographically will assess by the number of participants with symptoms-free and no peri-radicular pathology at 369and 12 months
No clinical or radiographic evidence of pulp degeneration such as spontaneous pain excessive bleeding from the root canal internal root resorption inter-radicular andor periapical bone destruction swelling or sinus tract
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