Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06227390
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2023-12-22
Brief Title:
Clinical and Radiographic Outcomes of Partial Pulpotomy Procedure in Primary Molars Utilizing Different Capping Materials and Different Restorative Methods
Sponsor:
British University In Egypt
Organization:
British University In Egypt
Study Overview
Official Title:
Clinical and Radiographic Outcomes of Partial Pulpotomy Procedure in Primary Molars Utilizing Different Capping Materials and Different Restorative Methods A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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 compare clinical and radiographic outcomes of partial pulpotomy in vital primary molars using TheraCal PT Biodentin and NeoPUTTY MTA followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown
Detailed Description:
Primary teeth act as natural space maintainers for the subsequent dentition they also aid in mastication satisfactory esthetics and proper articulation of letters So it is of prime importance to maintain and preserve their vitality and function through vital pulp therapy VPT Ideal VPT materials would sustain pulp vitality encourage pulp healing Due to their biocompatibility bioactivity and superior sealing capacity tricalcium silicates TCSs such as mineral trioxide aggregate MTA and Biodentine are currently the most widely used materials for VPT in permanent and primary teethOther calcium silicate-based compounds such as TheraCal PT have recently been introduced to the market TheraCal PT a dual-cured variation of its light-cured predecessor Theracal LC has improved its chemical capabilities to mitigate the potential harmful consequences of leaving un polymerized monomers
The best course of action for primary molars with deep carious lesions that arent exhibiting any symptoms or indicators of irreversible pulpitis has posed challenges for years With pulp capping and pulpotomy available as options for primary teeth and partial pulpotomy in young permanent teeth according to the American Academy of Pediatric Dentistry AAPD guidelines for vital pulp therapy A less invasive version of pulpotomy which is partial pulpotomy uses more conservative theories and biologic principles to produce better clinical results
New iterations of calcium silicate-based materials have been created for usage as vital pulp therapy material due to their advantageous biological physical and mechanical qualities Additionally they promote growth factor production and differentiation into odontoblast like cells
TheraCal PT advantages include that it has a hydrophilic matrix which releases Calcium ions Koutroulis et alstated that the increased antibacterial efficacy and calcium release are strongly linked Also Calcium release has been linked to the biological characteristics of hydraulic cements because it promotes the differentiation potential of dental pulp cells and enhances mineralization which results in deposition of a dentine-like barrier on the pulps surface on the long-term The other advantage that it increases the pH which provides anti-bacterial activity
there is lack of evidence in partial pulpotomy in treatment of carious primary teeth the materials that could be used in it and necessity of using crown after it
this clinical trial will be performed to provide evidence based answer for treatment of primary molars using partial pulpotomy the materials that could be used in it and necessity of using crown after it
- Children will be allocated into either one of the groups of partial pulpotomy depending on the medicament used as follows
Group 1A control group MTA and stainless-steel crown
Group 1B MTA and glass ionomer restoration
Group 2A Biodentin and stainless-steel crown
Group 2B Biodentin and glass ionomer restoration
Group 3A TheraCal PT and stainless-steel crown
Group 3B TheraCal PT and glass ionomer restoration All of the medicaments will be applied according to the manufacturers instructions and gently placed over the pulp tissue to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement
Clinical follow up after 369 and12 months while radiographic follow up every 6 months
Parents will be asked if any complains occurred between follow up visits by phone
The best course of action for primary molars with deep carious lesions that arent exhibiting any symptoms or indicators of irreversible pulpitis has posed challenges for years With pulp capping and pulpotomy available as options for primary teeth and partial pulpotomy in young permanent teeth according to the American Academy of Pediatric Dentistry AAPD guidelines for vital pulp therapy A less invasive version of pulpotomy which is partial pulpotomy uses more conservative theories and biologic principles to produce better clinical results
New iterations of calcium silicate-based materials have been created for usage as vital pulp therapy material due to their advantageous biological physical and mechanical qualities Additionally they promote growth factor production and differentiation into odontoblast like cells
TheraCal PT advantages include that it has a hydrophilic matrix which releases Calcium ions Koutroulis et alstated that the increased antibacterial efficacy and calcium release are strongly linked Also Calcium release has been linked to the biological characteristics of hydraulic cements because it promotes the differentiation potential of dental pulp cells and enhances mineralization which results in deposition of a dentine-like barrier on the pulps surface on the long-term The other advantage that it increases the pH which provides anti-bacterial activity
there is lack of evidence in partial pulpotomy in treatment of carious primary teeth the materials that could be used in it and necessity of using crown after it
this clinical trial will be performed to provide evidence based answer for treatment of primary molars using partial pulpotomy the materials that could be used in it and necessity of using crown after it
- Children will be allocated into either one of the groups of partial pulpotomy depending on the medicament used as follows
Group 1A control group MTA and stainless-steel crown
Group 1B MTA and glass ionomer restoration
Group 2A Biodentin and stainless-steel crown
Group 2B Biodentin and glass ionomer restoration
Group 3A TheraCal PT and stainless-steel crown
Group 3B TheraCal PT and glass ionomer restoration All of the medicaments will be applied according to the manufacturers instructions and gently placed over the pulp tissue to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement
Clinical follow up after 369 and12 months while radiographic follow up every 6 months
Parents will be asked if any complains occurred between follow up visits by phone
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