Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625645
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
Comparative Evaluation of Antimicrobial Efficacy Clinical and Radiographic Success of Calcium Hydroxide Chlorhexidine and Modified Triple Antibiotic Paste in Different Combination Forms As Intracanal Medicaments Against Enterococcus Faecalis in Primary Teeth
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Evaluation of Antimicrobial Efficacy Clinical and Radiographic Success of Calcium Hydroxide Chlorhexidine and Modified Triple Antibiotic Paste in Different Combination Forms As Intracanal Medicaments Against Enterococcus Faecalis in Primary Teeth a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparing between different intracanal medications with different combination forms of Modified Triple Antibiotic Paste Calcium Hydroxide and Chlorehexidine regarding antimicrobial efficacy through bacterial reduction count of enterococcus Faecalis and regarding clinical and radiographic success in non vital primary teeth necessitating pulpectomy with follow up time 1 year
Detailed Description:
1 Full medical and dental history will be obtained from the parents of the patients participating in this study
2 A thorough clinical and radiographic examination of the tooth to be treated will be done
3 The tooth will be anaesthetized using the inferior alveolar nerve block technique for lower molars and infiltration for upper molars
4 Before isolation antisepsis of the oral cavity will be performed by rinsing for 1 min with 10 mL chlorhexidine gluconate mouth-wash 02
5 The tooth will be properly isolated using rubber dam
6 Access cavity will be performed using a round bur
7 The root canals will be irrigated with 1 ml sterile saline solution
8 Patency of the root canal will be obtained using stainless steel hand k- files size 15
9 Working length will be determined using apex locator
10 The first microbial samples S1 will be collected to assess bacterial count of the root canals using 1 sterile paper point size 20 which will be inserted into the widest root canal for 1 min with pumping movements McGurkin-Smith et al 2005
11 It will be placed inside sterile tubes containing a reduced transport medium of thioglycolate
12 The canals will be thoroughly irrigated using 3ml syringe of 125 Sodium hypochlorite A side-vented needle will be used to control the possibility of irrigant apical extrusion
13 Mechanical preparation will be performed with rotary system for all the cases
14 Irrigation with saline solution will be used to neutralize all the previously used solutions
15 Then a second microbial samples S2 representing the antibacterial effect of the mechanical preparation will be obtained with the same procedure as the first sample S1
16 According to the randomization sequence patients will be assigned to one of 4 groups
1- A mix of modified triple Antibiotic Paste M-TAP and normal saline experimental
2- A mix of CaOH2 and 2 CHX gluconate solutionexperimental 3- A mix of M-TAP and 2 CHX gluconate solutionexperimental 4- A mix of CaOH2 and normal saline control 17 The canals will be dried and filled with intracanal medication plugged into the canal by using a plugger
18 At the end of the first visit a piece of sterile cotton will be placed in the pulp chamber
19 All teeth will be dressed with intermediate restorative material IRM as a temporary filling in order to ensure proper sealing with no leakage of any oral fluids inside the root canal which might disturb the action of the intracanal medication
20 After 7 days the temporary restoration will be removed 21 Disinfection of the operative field will take place as performed previously using the same protocol
22 Irrigation of the root canals with 2 mL of saline to flush out the medicaments and the third bacteriological sample S3 will be taken out
23 Later canals will be filled with Metapex Metabiomed Korea followed by the placement of stainless-steel crowns 3M ESPE
24 The samples will be placed in sterile vials with thioglycolate transport medium The vials will be sealed tightly to avoid contamination and labeled The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection and samples will be assessed for total E faecalis count Qamar et al 2023
2 A thorough clinical and radiographic examination of the tooth to be treated will be done
3 The tooth will be anaesthetized using the inferior alveolar nerve block technique for lower molars and infiltration for upper molars
4 Before isolation antisepsis of the oral cavity will be performed by rinsing for 1 min with 10 mL chlorhexidine gluconate mouth-wash 02
5 The tooth will be properly isolated using rubber dam
6 Access cavity will be performed using a round bur
7 The root canals will be irrigated with 1 ml sterile saline solution
8 Patency of the root canal will be obtained using stainless steel hand k- files size 15
9 Working length will be determined using apex locator
10 The first microbial samples S1 will be collected to assess bacterial count of the root canals using 1 sterile paper point size 20 which will be inserted into the widest root canal for 1 min with pumping movements McGurkin-Smith et al 2005
11 It will be placed inside sterile tubes containing a reduced transport medium of thioglycolate
12 The canals will be thoroughly irrigated using 3ml syringe of 125 Sodium hypochlorite A side-vented needle will be used to control the possibility of irrigant apical extrusion
13 Mechanical preparation will be performed with rotary system for all the cases
14 Irrigation with saline solution will be used to neutralize all the previously used solutions
15 Then a second microbial samples S2 representing the antibacterial effect of the mechanical preparation will be obtained with the same procedure as the first sample S1
16 According to the randomization sequence patients will be assigned to one of 4 groups
1- A mix of modified triple Antibiotic Paste M-TAP and normal saline experimental
2- A mix of CaOH2 and 2 CHX gluconate solutionexperimental 3- A mix of M-TAP and 2 CHX gluconate solutionexperimental 4- A mix of CaOH2 and normal saline control 17 The canals will be dried and filled with intracanal medication plugged into the canal by using a plugger
18 At the end of the first visit a piece of sterile cotton will be placed in the pulp chamber
19 All teeth will be dressed with intermediate restorative material IRM as a temporary filling in order to ensure proper sealing with no leakage of any oral fluids inside the root canal which might disturb the action of the intracanal medication
20 After 7 days the temporary restoration will be removed 21 Disinfection of the operative field will take place as performed previously using the same protocol
22 Irrigation of the root canals with 2 mL of saline to flush out the medicaments and the third bacteriological sample S3 will be taken out
23 Later canals will be filled with Metapex Metabiomed Korea followed by the placement of stainless-steel crowns 3M ESPE
24 The samples will be placed in sterile vials with thioglycolate transport medium The vials will be sealed tightly to avoid contamination and labeled The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection and samples will be assessed for total E faecalis count Qamar et al 2023
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None