Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232941
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-09-13
Brief Title:
Comparative Evaluation of Three Pulpotomy Agents for Permanent Mature Molars With Irreversible Pulpitis
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Comparative Evaluation of Three Calcium Silicate Based Materials as Pulpotomy Agents for Permanent Mature Molars With Irreversible Pulpitis Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
Statement of the problem
Accurate pulpal diagnosis is essential for decision making between vital pulp therapy and root canal treatment Clinical and radiographic examinations do not correctly reflect the histological state of the pulp and consequently its ability to heal Also despite the various advantages of using MTA as a pulp capping agent it has several drawbacks
Aim of the study
The aim of the study is to compare two types of calcium silicate-based materials to MTA in permanent mature molars diagnosed with irreversible pulpitis regarding the following parameters level of inflammatory biomarker level clinical and radiographic outcomes
Materials and methods
Thirty-six patients with mature permanent molars exhibiting signs and symptoms indicative of irreversible pulpitis will be enrolled A careful periodontal treatment and standardized operative procedure will be followed for all participants Gingival crevicular fluid samples will be obtained before any local anesthetics administration followed by isolation of teeth with a dental dam and removal of caries Pulpotomy will be performed using sterile round bur till level of orifices and then haemostasis will be achieved using sodium hypochlorite At this point patients will be randomly divided into three groups of 12 depending on the type of calcium silicate-based material used Later resin modified glass ionomer will be applied etching bonding and placement of composite as the permanent restoration Follow up clinically and radiographically will be done
Accurate pulpal diagnosis is essential for decision making between vital pulp therapy and root canal treatment Clinical and radiographic examinations do not correctly reflect the histological state of the pulp and consequently its ability to heal Also despite the various advantages of using MTA as a pulp capping agent it has several drawbacks
Aim of the study
The aim of the study is to compare two types of calcium silicate-based materials to MTA in permanent mature molars diagnosed with irreversible pulpitis regarding the following parameters level of inflammatory biomarker level clinical and radiographic outcomes
Materials and methods
Thirty-six patients with mature permanent molars exhibiting signs and symptoms indicative of irreversible pulpitis will be enrolled A careful periodontal treatment and standardized operative procedure will be followed for all participants Gingival crevicular fluid samples will be obtained before any local anesthetics administration followed by isolation of teeth with a dental dam and removal of caries Pulpotomy will be performed using sterile round bur till level of orifices and then haemostasis will be achieved using sodium hypochlorite At this point patients will be randomly divided into three groups of 12 depending on the type of calcium silicate-based material used Later resin modified glass ionomer will be applied etching bonding and placement of composite as the permanent restoration Follow up clinically and radiographically will be done
Detailed Description:
For many centuries there has been a closely held belief that any vital mature permanent tooth diagnosed with irreversible pulpitis will require root canal treatment The reason for such treatment modality is the high success rate reaching 100 if performed with high standards1 However many studies have demonstrated that root canal therapy can be time-consuming2 necessitate multiple visits3 be expensive for both the patient and the dentist and can increase the likelihood that the tooth will fracture because of the loss of tooth structure2
On the other hand vital pulp therapy VPT provides many advantages compared to root canal treatment For example it maintains the proprioceptive sensation of the tooth biological immune response from the retained pulp tissue can prevent infection of the apical area regenerative and repair potential of the pulp is retained structural integrity of the tooth is maintained lowering the risk of fracture and there is a notable decrease in pain and discomfort for the patient 4
More conservative VPT like pulpotomy was limited to immature teeth with mechanical carious or traumatic pulp exposure who dont exhibit any periapical disease In such cases the goal has been to ensure completion of root formation apexogenesis5 However the European Society of Endodontology ESE and the American Association of Endodontists AAE recently released position statements stating that pre-treatment diagnosis of irreversible pulpitis is not necessarily an indication for pulpectomy ushering in a new era for minimally invasive VPT in mature permanent teeth Although several studies 814found that using mineral trioxide aggregate MTA for VPT of cariously exposed permanent teeth with irreversible pulpitis resulted in high clinical success rates Clinically there have been various complaints against MTA There have been reports of difficult handling prolonged setting time expensive cost and probable tooth discoloration By far the most popular and widely utilized materials in the endodontic therapy are calcium silicate cements Odontocem Australian Dental Manufacturing Brisbane Australia is a calcium silicate-based technology containing 02 of the low steroid triamcinolone acetonide and has outstanding biocompatibility handling properties and least amount of staining potential It can be utilised as a dentine substitute for lining deep cavities Odontocem is proposed to provide antibacterial activity due to its initial high PH and pain relief due to the presence of a potent steroid 16
Another calcium silicate material that is also recently introduced in the market is NeoPutty Avalon Biomed Inc Bradenton USA NeoPutty is premixed format of tricalcium silicate-based material Bioceramic Its composed of tantalum oxide tricalcium silicate calcium aluminate dicalcium silicate tricalcium aluminate and calcium sulfate17 Guillen et al 2022 17compared the cytocompatibility of NeoPutty to NeoMTA Plus and MTA Angelus and concluded that all three materials provided adequate cytocompatibility and preliminary evidence that NeoPutty can be used as pulp capping agent in VPT
On the other hand vital pulp therapy VPT provides many advantages compared to root canal treatment For example it maintains the proprioceptive sensation of the tooth biological immune response from the retained pulp tissue can prevent infection of the apical area regenerative and repair potential of the pulp is retained structural integrity of the tooth is maintained lowering the risk of fracture and there is a notable decrease in pain and discomfort for the patient 4
More conservative VPT like pulpotomy was limited to immature teeth with mechanical carious or traumatic pulp exposure who dont exhibit any periapical disease In such cases the goal has been to ensure completion of root formation apexogenesis5 However the European Society of Endodontology ESE and the American Association of Endodontists AAE recently released position statements stating that pre-treatment diagnosis of irreversible pulpitis is not necessarily an indication for pulpectomy ushering in a new era for minimally invasive VPT in mature permanent teeth Although several studies 814found that using mineral trioxide aggregate MTA for VPT of cariously exposed permanent teeth with irreversible pulpitis resulted in high clinical success rates Clinically there have been various complaints against MTA There have been reports of difficult handling prolonged setting time expensive cost and probable tooth discoloration By far the most popular and widely utilized materials in the endodontic therapy are calcium silicate cements Odontocem Australian Dental Manufacturing Brisbane Australia is a calcium silicate-based technology containing 02 of the low steroid triamcinolone acetonide and has outstanding biocompatibility handling properties and least amount of staining potential It can be utilised as a dentine substitute for lining deep cavities Odontocem is proposed to provide antibacterial activity due to its initial high PH and pain relief due to the presence of a potent steroid 16
Another calcium silicate material that is also recently introduced in the market is NeoPutty Avalon Biomed Inc Bradenton USA NeoPutty is premixed format of tricalcium silicate-based material Bioceramic Its composed of tantalum oxide tricalcium silicate calcium aluminate dicalcium silicate tricalcium aluminate and calcium sulfate17 Guillen et al 2022 17compared the cytocompatibility of NeoPutty to NeoMTA Plus and MTA Angelus and concluded that all three materials provided adequate cytocompatibility and preliminary evidence that NeoPutty can be used as pulp capping agent in VPT
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