Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632015
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Evaluation of the Effect of Different Medicaments Used in Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis on Post-Operative Endodontic Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effect of Different Medicaments Used in Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis on Post-Operative Endodontic Pain A Randomized Controlled Double-Blind Clinical Trial
Status:
COMPLETED
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:
In this randomized clinical study the aim is to compare the effects of calcium hydroxide sodium diclofenac and the combined use of calcium hydroxide with sodium diclofenac as an intracanal medicament on postoperative endodontic pain in teeth with irreversible pulpitis and symptomatic apical periodontitis
Primary Hypothesis There is no effect of calcium hydroxide sodium diclofenac and the combined use of calcium hydroxide with sodium diclofenac as an intracanal medicament on postoperative endodontic pain in teeth with irreversible pulpitis and symptomatic apical periodontitis
Materials and Methods
In this study ninety patients diagnosed with irreversible pulpitis and symptomatic apical periodontitis exhibiting spontaneous pain and percussion pain levels above 50 on a 100 mm Visual Analog Scale VAS during the preoperative period were included After root canal preparation using Reciproc files VDW the patients were randomly assigned to three groups based on the intracanal medicament used calcium hydroxide group n30 calcium hydroxide and diclofenac sodium combination group n30 and diclofenac sodium group n30 Postoperative spontaneous pain scores were recorded daily using the VAS for one week The collected data were statistically analyzed
Primary Hypothesis There is no effect of calcium hydroxide sodium diclofenac and the combined use of calcium hydroxide with sodium diclofenac as an intracanal medicament on postoperative endodontic pain in teeth with irreversible pulpitis and symptomatic apical periodontitis
Materials and Methods
In this study ninety patients diagnosed with irreversible pulpitis and symptomatic apical periodontitis exhibiting spontaneous pain and percussion pain levels above 50 on a 100 mm Visual Analog Scale VAS during the preoperative period were included After root canal preparation using Reciproc files VDW the patients were randomly assigned to three groups based on the intracanal medicament used calcium hydroxide group n30 calcium hydroxide and diclofenac sodium combination group n30 and diclofenac sodium group n30 Postoperative spontaneous pain scores were recorded daily using the VAS for one week The collected data were statistically analyzed
Detailed Description:
A web program available at wwwrandomizerorg was used for randomization Based on the power analysis conducted the minimum required number of patients for each group was determined to be twenty-six effect size 0797 80 power Therefore 30 patients were included in each group Patients included in the study were informed about the research and written consent was obtained from each participant These patients were rated for preoperative spontaneous and percussion pain on the Visual Analog Scale VAS Demographic data and contact information of the patients were recorded
All patients received mandibular block anesthesia with 4 articaine containing 1200000 epinephrine After preparing the access cavity the treatment procedure was completed using rubber dam isolation An apex locator was utilized to determine the working length The root canals were irrigated with 2 mL of 25 NaOCl and Reciproc files R25 R40 were used for the root canal shaping process The root canals were expanded using the VDW Resiproc Ni-Ti rotary file system and the X-Smart Plus Dentsply Maillefer endodontic motor in the reciprocating mode Following the manufacturers recommendations the crown-down technique was employed with mesial canals prepared to R25 and the distal canal prepared to R40 006 achieving an apical width of 040 mm for the working length final preparation Each root canal was prepared up to three file sizes larger than the first file that reached the working length Between each file change 2 mL of 25 NaOCl was used A 10 K-file was utilized to maintain the apical patency between file changes Finally the last irrigation was performed with 5 mL of 25 NaOCl and 5 mL of 17 EDTA Subsequently the root canals were dried with paper points and the selected intracanal medicament was placed in the root canals
A total of 90 patients were randomly divided into three groups based on the intracanal medicament used
Groups
Group 1 1 mL of distilled water with 1 g of CaOH2 powder
Group 2 1 mL of distilled water with 1 g of sodium diclofenac
Group 3 1 mL of distilled water with 950 mg of CaOH2 powder 50 mg of sodium diclofenac A simple randomization technique was utilized by an independent person to generate a random sequence online wwwrandomorg with numbers ranging from 1 to 90 These numbers were then randomly assigned to three study groups based on the intracanal medicament placement A CaOH2 powder B sodium diclofenac C CaOH2 powder sodium diclofenac using the web program After generating the random codes eg 3-C 14-B 56-A the intracanal medicaments were stored in sealed envelopes This ensured that the treating physician had no information regarding the type of intracanal medicament or the patient group
This study was designed as a randomized controlled double-blind single-center clinical trial The researcher patients and analyst biostatistician were blinded to the type of intracanal medicament used The intracanal medicaments were placed into the root canals at a level approximately 1 mm short of the working length using a lentulo The amount of intracanal medicament 1 g of powder and 1 mL of distilled water was standardized to be equal across all groups Sterile cotton pellets were used to close the canal entrances and Cavit was employed to fill the access cavities
Patients were asked to rate their pain daily on a VAS form for one week They were prescribed 400 mg of ibuprofen to take in case of severe pain and were instructed to record the number of analgesics taken and the days they used them Patients were recalled for a follow-up visit one week after the treatment During this second session after the percussion test conducted by the operator the intracanal medicament was removed using sterile saline 5 mL of 17 EDTA and the master apical file Additionally the 5 EDTA was activated using sonic activation The root canals were filled with gutta-percha and a bioceramic-based paste using the lateral compaction technique The final restoration was performed in the pulp chamber using flowable composite resin and nanohybrid composite resin
All patients received mandibular block anesthesia with 4 articaine containing 1200000 epinephrine After preparing the access cavity the treatment procedure was completed using rubber dam isolation An apex locator was utilized to determine the working length The root canals were irrigated with 2 mL of 25 NaOCl and Reciproc files R25 R40 were used for the root canal shaping process The root canals were expanded using the VDW Resiproc Ni-Ti rotary file system and the X-Smart Plus Dentsply Maillefer endodontic motor in the reciprocating mode Following the manufacturers recommendations the crown-down technique was employed with mesial canals prepared to R25 and the distal canal prepared to R40 006 achieving an apical width of 040 mm for the working length final preparation Each root canal was prepared up to three file sizes larger than the first file that reached the working length Between each file change 2 mL of 25 NaOCl was used A 10 K-file was utilized to maintain the apical patency between file changes Finally the last irrigation was performed with 5 mL of 25 NaOCl and 5 mL of 17 EDTA Subsequently the root canals were dried with paper points and the selected intracanal medicament was placed in the root canals
A total of 90 patients were randomly divided into three groups based on the intracanal medicament used
Groups
Group 1 1 mL of distilled water with 1 g of CaOH2 powder
Group 2 1 mL of distilled water with 1 g of sodium diclofenac
Group 3 1 mL of distilled water with 950 mg of CaOH2 powder 50 mg of sodium diclofenac A simple randomization technique was utilized by an independent person to generate a random sequence online wwwrandomorg with numbers ranging from 1 to 90 These numbers were then randomly assigned to three study groups based on the intracanal medicament placement A CaOH2 powder B sodium diclofenac C CaOH2 powder sodium diclofenac using the web program After generating the random codes eg 3-C 14-B 56-A the intracanal medicaments were stored in sealed envelopes This ensured that the treating physician had no information regarding the type of intracanal medicament or the patient group
This study was designed as a randomized controlled double-blind single-center clinical trial The researcher patients and analyst biostatistician were blinded to the type of intracanal medicament used The intracanal medicaments were placed into the root canals at a level approximately 1 mm short of the working length using a lentulo The amount of intracanal medicament 1 g of powder and 1 mL of distilled water was standardized to be equal across all groups Sterile cotton pellets were used to close the canal entrances and Cavit was employed to fill the access cavities
Patients were asked to rate their pain daily on a VAS form for one week They were prescribed 400 mg of ibuprofen to take in case of severe pain and were instructed to record the number of analgesics taken and the days they used them Patients were recalled for a follow-up visit one week after the treatment During this second session after the percussion test conducted by the operator the intracanal medicament was removed using sterile saline 5 mL of 17 EDTA and the master apical file Additionally the 5 EDTA was activated using sonic activation The root canals were filled with gutta-percha and a bioceramic-based paste using the lateral compaction technique The final restoration was performed in the pulp chamber using flowable composite resin and nanohybrid composite resin
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