Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461728
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-11
Brief Title:
Minimal Instrumentation With Intracanal Heating and Activation of Sodium Hypochlorite for the Management of Teeth With Periapical Lesions
Sponsor:
Saint-Joseph University
Organization:
Saint-Joseph University
Study Overview
Official Title:
Minimal Instrumentation With Intracanal Heating ad Activation of Sodium Hypochlorite for
Status:
RECRUITING
Status Verified Date:
2024-06
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:
this study is the first to demonstrate the efficacy of minimally invasive root canal treatment combined with intracanal heating and activation of NaOCl using a prototype needle on the healing of asymptomatic apical periodontitis of necrotic single rooted teeth 32 teeth will be randomaly assigned into 2 groups conventional and conservative technique In the conventional group each canal will be prepared using Reciproc Blue 2508 approximetly 27 ml of NaOCl will be used the canal will be activated using 2002 taper tip of a sonic decive This cyclel will be repeated 3 times and the obturation will be done using a single cone technique with AH plus resin-based sealer In the second group a size 10 k file will be introduced to confirm patency and to record working length after filling the canal with NaOCl A glide path will be established using the size 10 FlexoFile to the WL than Proglider 1602 to the foramen After the glide path the canal will be irrigated with 3 ml of 5 25 of NaOCL The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point in order to heat and activate the irrigant solution for 30 secondsStep one is repeated 4 more times and a fresh solution of NaOCl is replaced every time Canals will be dried using sterile paper points size 15 and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2 tapered
Detailed Description:
32 single rooted teeth with pulp necrosis and asymptomatic apical periodontitis as confirmed by negative response to cold tests and the absence of bleeding on entering the pulp chamber also radiographs will be included in this study and the periapical status will be decided in accord with the periapical Index PAI
The endodontic procedure will be performed under strict aseptic settings and a dental operation microscopea After confirming the clinical and radiological diagnosis the access cavity will be performed using sterile round diamond then a size 10 FlexoFile Dentsply Maillfer Ballaigues Switzerland will be introduced to confirm patency and to record working length after filling the canal with sodium hypochlorite
Then a size 15 Flexofile DentsplyMaillferBallaiguesSwitzerlandwill be introduced into the canal only root canals with an initial apical size equivalent to 15 k file will be selected and roots with larger foramina will be excludedThen the teeth will be randomly assigned into two experimental groupsn16 conventional or conservative technique
Group 1 conventional rotary instrumentation Each canal will be prepared using Reciproc Blue nickel titanium file 2508 VDW Munich Germany according to the manufacturers instructions Continuous checking of the canal patency will be done using size 10 hand file followed by irrigation with 3 ml of 525 sodium hypochlorite at room temperature using irriflex endodontic irrigation needle Produits Dentaires SA Vevey Switzerland mounted on a 3ml syringe Plastipak Franklin Lakes NJ USA Each time the instrument will be removed out of the canal and before using the next instrument Approximately 27 ml of NaOCl will be used until Reciproc Blue reaches WL Once the instrumentation is done the canal will be irrigated with 5 ml of 17 ethylenediaminetetraacetic acid EDTA keeping it in the canal for 3 minutes and then flushed with 5 ml of saline
In the end the canal will be filled with 525 NaOCl at room temperature and and activated using the size 20 02 taper tip of a sonic device EndoActivator Dentsply Tulsa Dental Specialties Tulsa OK USA at 10000 cyclesmin and the activator tip will be placed within 2 mm of the working length
This cycle will be repeated three times and the canal will be rinsed with 3 ml of 525 NaOCl at room temperature after each cycle
After the completion of the endodontic procedures gauging of the apex will be done The canals will be dried using sterile paper points size 25 MaillferBallaiguesSwitzerland
The obturation will be done using a single cone technique AH plus resin-based sealer DentsplyDeTreyKonstanzGermany will be mixed as per the manufacturers instructions and applied to the root canal walls using a lentulo spiral also the apical third of the gutta-percha size 25 MaillferBaillaiguesSwitzerland will be coated with sealer and gently inserted into the canal to the working length Excess of gutta-percha will be cut at the CEJ with a heat plugger Fast-Pack pro-obturation system and the coronal part of the gutta-percha will be condensed with gentle pressure using an endodontic plugger Heat carrier Dentsply MaillferBallaiguesSwitzerland
Group 2 in the conservative technique a size 10 FlexoFile DentsplyMaillferBallaiguesSwitzerland will be introduced to confirm patency and to record working length after filling the canal with NaOCl A glide path will be established using the size 10 FlexoFile to the WL than Proglider 1602 to the foramen After the glide path the canal will be irrigated with 3 ml of 5 25 of NaOCL at room temperature using irriflex endodontic needle Produits Dentaires SA Vevey Switzerland mounted on a 3ml syringe Plastipak Franklin Lakes NJ USA NaOCL is left in the canal and access cavity The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point in order to heat and activate the irrigant solution for 30 seconds The tip will be moved with small few mm in-and out movement Than NaOCl will be aspirated from the canal and the access cavity than the canal will be filled with 17 EDTA keeping it in the canal for 3 minutes followed by saline Saline is aspirated Step one is repeated 4 more times and a fresh solution of NaOCl is replaced every time Canals will be dried using sterile paper points size 15 MaillferBallaiguesSwitzerland and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2 tapered DentsplyMaillferBallaiguesSwitzerland
The endodontic procedure will be performed under strict aseptic settings and a dental operation microscopea After confirming the clinical and radiological diagnosis the access cavity will be performed using sterile round diamond then a size 10 FlexoFile Dentsply Maillfer Ballaigues Switzerland will be introduced to confirm patency and to record working length after filling the canal with sodium hypochlorite
Then a size 15 Flexofile DentsplyMaillferBallaiguesSwitzerlandwill be introduced into the canal only root canals with an initial apical size equivalent to 15 k file will be selected and roots with larger foramina will be excludedThen the teeth will be randomly assigned into two experimental groupsn16 conventional or conservative technique
Group 1 conventional rotary instrumentation Each canal will be prepared using Reciproc Blue nickel titanium file 2508 VDW Munich Germany according to the manufacturers instructions Continuous checking of the canal patency will be done using size 10 hand file followed by irrigation with 3 ml of 525 sodium hypochlorite at room temperature using irriflex endodontic irrigation needle Produits Dentaires SA Vevey Switzerland mounted on a 3ml syringe Plastipak Franklin Lakes NJ USA Each time the instrument will be removed out of the canal and before using the next instrument Approximately 27 ml of NaOCl will be used until Reciproc Blue reaches WL Once the instrumentation is done the canal will be irrigated with 5 ml of 17 ethylenediaminetetraacetic acid EDTA keeping it in the canal for 3 minutes and then flushed with 5 ml of saline
In the end the canal will be filled with 525 NaOCl at room temperature and and activated using the size 20 02 taper tip of a sonic device EndoActivator Dentsply Tulsa Dental Specialties Tulsa OK USA at 10000 cyclesmin and the activator tip will be placed within 2 mm of the working length
This cycle will be repeated three times and the canal will be rinsed with 3 ml of 525 NaOCl at room temperature after each cycle
After the completion of the endodontic procedures gauging of the apex will be done The canals will be dried using sterile paper points size 25 MaillferBallaiguesSwitzerland
The obturation will be done using a single cone technique AH plus resin-based sealer DentsplyDeTreyKonstanzGermany will be mixed as per the manufacturers instructions and applied to the root canal walls using a lentulo spiral also the apical third of the gutta-percha size 25 MaillferBaillaiguesSwitzerland will be coated with sealer and gently inserted into the canal to the working length Excess of gutta-percha will be cut at the CEJ with a heat plugger Fast-Pack pro-obturation system and the coronal part of the gutta-percha will be condensed with gentle pressure using an endodontic plugger Heat carrier Dentsply MaillferBallaiguesSwitzerland
Group 2 in the conservative technique a size 10 FlexoFile DentsplyMaillferBallaiguesSwitzerland will be introduced to confirm patency and to record working length after filling the canal with NaOCl A glide path will be established using the size 10 FlexoFile to the WL than Proglider 1602 to the foramen After the glide path the canal will be irrigated with 3 ml of 5 25 of NaOCL at room temperature using irriflex endodontic needle Produits Dentaires SA Vevey Switzerland mounted on a 3ml syringe Plastipak Franklin Lakes NJ USA NaOCL is left in the canal and access cavity The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point in order to heat and activate the irrigant solution for 30 seconds The tip will be moved with small few mm in-and out movement Than NaOCl will be aspirated from the canal and the access cavity than the canal will be filled with 17 EDTA keeping it in the canal for 3 minutes followed by saline Saline is aspirated Step one is repeated 4 more times and a fresh solution of NaOCl is replaced every time Canals will be dried using sterile paper points size 15 MaillferBallaiguesSwitzerland and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2 tapered DentsplyMaillferBallaiguesSwitzerland
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