Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403293
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2024-05-03
Brief Title:
Influence of Sonic Activation of Root Sealers on Post-Operative Pain
Sponsor:
Mustafa Kemal University
Organization:
Mustafa Kemal University
Study Overview
Official Title:
Influence of Sonic Activation of Epoxy Resin and Calcium Silicate Sealer on Post-Operative Pain A Patient-Blinded Randomised Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Aim This clinical study aims to compare post-operative pain after single-visit root canal treatment of teeth with asymptomatic apical periodontitis using epoxy-resin based AH Plus and calcium silicate based Endosequence BC sealers with or without sonic activation
Materials and Methods The study included 72 individuals having one first or second mandibular premolar tooth with asymptomatic apical periodontitis They were randomly divided into 4 groups according to the root canal sealer AH Plus or Endosequence BC and activation protocol sonic activation or non-activation n18 Participants were ask to rate their post-operative pain intensity on a NRS scale as none minimal moderate or severe after 24 h 48 h 72 h and 7 days following treatment Patients were also asked to record the number of prescribed analgesic medication tablets ibuprofen 400 mg taken The collected data were statistically analyzed at 005 significance level
Materials and Methods The study included 72 individuals having one first or second mandibular premolar tooth with asymptomatic apical periodontitis They were randomly divided into 4 groups according to the root canal sealer AH Plus or Endosequence BC and activation protocol sonic activation or non-activation n18 Participants were ask to rate their post-operative pain intensity on a NRS scale as none minimal moderate or severe after 24 h 48 h 72 h and 7 days following treatment Patients were also asked to record the number of prescribed analgesic medication tablets ibuprofen 400 mg taken The collected data were statistically analyzed at 005 significance level
Detailed Description:
Root Canal Treatment After inferior alveolar nervus block anesthesia with 4 Articaine with 1100000 adrenaline the tooth was isolated with a rubber dam The access cavity was opened using high-speed diamond round burs under water cooling The working length WL was set at 05 mm shorter than the 00 reading using a 15 K-type file and apex locator Morita Root ZX Japan and checked with radiographs The root canals were prepared with Resiproc Resiproc VDW Munich Germany R25 and R40 files respectively at the WL using the crown down technique A total of 20 mL of 25 sodium hypochlorite NaOCl was used with a 30-gauge needle Max-i-Probe Dentsply Sirona during preparation 5 mL of distilled water was left in the canal for 1 min to neutralize the effect of NaOCl and then the root canals were irrigated with 3 ml of 17 ethylene diamine tetra acetic acid EDTA EDTA was activated for 3 20s with the EA 2504 tip 2 mm shorter than the WL The EA tip was used with 2-4 mm vertical strokes The root canals were irrigated with 5 mL distilled water and dried with paper points
The subjects were divided into four groups for root filling Randomization was performed using online software wwwrandomizerorg with a four-block-sized block randomization technique to ensure even distribution between the groups allocation ratio 1111 A co-investigator managed the allocation and reported the allocated treatment procedure to the operator The operator could not be blinded due to the different stages of the treatment protocols The patients were blinded to the chosen root canal sealer and activation protocol
The subjects were divided into four groups for root filling Randomization was performed using online software wwwrandomizerorg with a four-block-sized block randomization technique to ensure even distribution between the groups allocation ratio 1111 A co-investigator managed the allocation and reported the allocated treatment procedure to the operator The operator could not be blinded due to the different stages of the treatment protocols The patients were blinded to the chosen root canal sealer and activation protocol
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