Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-25 @ 2:56 PM
Study NCT ID:
NCT06075550
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers With Obturation Techniques
Sponsor:
Minia University
Organization:
Study Overview
Official Title:
Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers After Different Obturation Techniques: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-10
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:
60 patients were divided into 2 groups, 30 patient in each group
Group I: Obturation with TotalFill BC Sealer using the single cone technique
Group II: Obturation with TotalFill BC Sealer HiFlow using the warm vertical compaction technique.
Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.
Group I: Obturation with TotalFill BC Sealer using the single cone technique
Group II: Obturation with TotalFill BC Sealer HiFlow using the warm vertical compaction technique.
Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.
Detailed Description:
Endodontic treatment will be performed in a single visit
Root canal preparation
* After anesthesia a rubber dam will be placed then disinfection of the working field will be done using sodium hypochlorite swab.
* All caries will be removed then an endodontic access cavity will be established using high speed carbide burs under coolant.
* Cleaning and shaping of the canal will be performed using rotary ProTaper Next files (Dentsply, Maillefer) connected to an endodontic motor according to the manufacturer's instructions and recommendations.
* Irrigation with sodium hypochlorite will be always performed during instrumentation.
* After instrumentation a final flush with sodium hypochlorite followed by distilled water will be performed and the canals will be dried using sterile paper points.
* Master cone radiograph will be taken for confirmation and obturation will be done according to the mentioned groups.
Root canal obturation
* This study will be a double blind randomized study.
* Group I: Using TotalFill BC Sealer, the tip of the syringe will be inserted into the canal and the sealer will be dispensed into the root canal as recommended by the manufacturer. A ProTaper Next gutta percha cone (Dentsply, Maillefer) of the same size of the prepared canal will be used for single cone obturation technique and the excess gutta percha will be removed by a heated condenser.
* Group II: TotalFill BC Sealer HiFlow will be inserted into the canal as in Group I and the master gutta percha cone will be placed and warm vertical compaction technique will be done. The depth of the heated plugger will be 5 mm less than the WL followed by back filling.
* After obturation, the access cavity will be cleaned and a sterile cotton pellet is placed and the cavity will be sealed with temporary filling.
* A postoperative radiograph will be taken
Assessment of postoperative pain
Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.
Root canal preparation
* After anesthesia a rubber dam will be placed then disinfection of the working field will be done using sodium hypochlorite swab.
* All caries will be removed then an endodontic access cavity will be established using high speed carbide burs under coolant.
* Cleaning and shaping of the canal will be performed using rotary ProTaper Next files (Dentsply, Maillefer) connected to an endodontic motor according to the manufacturer's instructions and recommendations.
* Irrigation with sodium hypochlorite will be always performed during instrumentation.
* After instrumentation a final flush with sodium hypochlorite followed by distilled water will be performed and the canals will be dried using sterile paper points.
* Master cone radiograph will be taken for confirmation and obturation will be done according to the mentioned groups.
Root canal obturation
* This study will be a double blind randomized study.
* Group I: Using TotalFill BC Sealer, the tip of the syringe will be inserted into the canal and the sealer will be dispensed into the root canal as recommended by the manufacturer. A ProTaper Next gutta percha cone (Dentsply, Maillefer) of the same size of the prepared canal will be used for single cone obturation technique and the excess gutta percha will be removed by a heated condenser.
* Group II: TotalFill BC Sealer HiFlow will be inserted into the canal as in Group I and the master gutta percha cone will be placed and warm vertical compaction technique will be done. The depth of the heated plugger will be 5 mm less than the WL followed by back filling.
* After obturation, the access cavity will be cleaned and a sterile cotton pellet is placed and the cavity will be sealed with temporary filling.
* A postoperative radiograph will be taken
Assessment of postoperative pain
Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.
Study Oversight
Has Oversight DMC:
True
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?: