Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778227
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-01-22
Brief Title:
Comparing Different Single and Combination Chelating Agents on Sealer Penetration and Dentin Erosion
Sponsor:
Dow University of Health Sciences
Organization:
Dow University of Health Sciences
Study Overview
Official Title:
Comparing the Dentin Conditioning Effect of Different Single and Combination Chelating Agents on Sealer Penetration and Dentin Erosion
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:
The basic aim of root canal treatment is to reduce the microbial content and prevent further recontamination in the canal Every tooth has a variable complex canal anatomy consisting of ramifications accessory and lateral canals Instrumentation alone cannot reach all the areas for cleaningThe objectives of this research study is to observe and compare the effect of irrigation with smearOFF etidronic acid hypochlorite and other irrigants on sealer penetration and dentin erosion of root dentin by using scanning electron microscope SEM and Energy Dispersive X-Ray Analysis EDX
Hundred extracted premolar teeth is subjected to root canal instrumentation The endodontic procedure is done with protaper gold files Initial irrigation is done by 5 sodium hypochlorite Samples are divided into five groups Each group consists of twenty single rooted premolars based on final irrigation regimen There will be four experimental groups which are as follows 1 17 EDTA 2 SmearOFF 3 Maleic acid 4 HEBPNaOCL Whereas saline will be the control group After the preparation and final irrigation of all teeth with experimental irrigants sterile saline is used to flush all canals and dried using paper points After final irrigation teeth are further divided into two groups A Sealer penetration B Dentin erosion In both the groups standardization of root length cleaning and shaping procedure are the same For sealer penetration obturation is done by warm vertical using AH plus sealer Samples are incubated at 37ยบ Celsius C and 100 humidity for 7 days The samples are marked and divided into three horizontal section at 2mm 5mm and 8mm Using SEM measure the maximum depth of sealer penetration on each side that is buccal lingual mesial and distal and take the mean for each section of sample For dentin erosion B samples are divided sagitally buccolingually into two halves The half containing the most visible part of apical area is taken and than examined using EDX One-Way ANOVA-test will be used to compare mean values of multiple groups Tukeys post hoc test will be used to determine the group with significance at P005 Two observers will evaluate the results using kappa statistics
Hundred extracted premolar teeth is subjected to root canal instrumentation The endodontic procedure is done with protaper gold files Initial irrigation is done by 5 sodium hypochlorite Samples are divided into five groups Each group consists of twenty single rooted premolars based on final irrigation regimen There will be four experimental groups which are as follows 1 17 EDTA 2 SmearOFF 3 Maleic acid 4 HEBPNaOCL Whereas saline will be the control group After the preparation and final irrigation of all teeth with experimental irrigants sterile saline is used to flush all canals and dried using paper points After final irrigation teeth are further divided into two groups A Sealer penetration B Dentin erosion In both the groups standardization of root length cleaning and shaping procedure are the same For sealer penetration obturation is done by warm vertical using AH plus sealer Samples are incubated at 37ยบ Celsius C and 100 humidity for 7 days The samples are marked and divided into three horizontal section at 2mm 5mm and 8mm Using SEM measure the maximum depth of sealer penetration on each side that is buccal lingual mesial and distal and take the mean for each section of sample For dentin erosion B samples are divided sagitally buccolingually into two halves The half containing the most visible part of apical area is taken and than examined using EDX One-Way ANOVA-test will be used to compare mean values of multiple groups Tukeys post hoc test will be used to determine the group with significance at P005 Two observers will evaluate the results using kappa statistics
Detailed Description:
Data Collection Extracted permanent premolars were collected from the department of Oral and maxillofacial surgery at Dow Dental College DDCDUHS and Dr Ishrat-ul-Ebad Khan Institute of Oral Health Sciences DIKIOHS DUHS Following extraction teeth were cleaned with tap water for all visible debris and stored in 01 thymol at 4 C until further use
METHODOLOGY
Extracted permanent premolars were collected from the department of Oral and maxillofacial surgery at Dow Dental College DDCDUHS and Dr Ishrat-ul-Ebad Khan Institute of Oral Health Sciences DIKIOHS DUHS Teeth were cleaned with the help of ultrasonic scaler for any visible debrissoft tissue remnants and calculus and later examined under dental operating microscope for any visible crack or fracture Teeth with presenting fracture craze lines developmental defects were discarded in accordance to the exclusion criteria Digital periapical radiographs PA at three different angulations 45 90 and 120 were taken to confirm the presence of a single straight canal within the root After fulfilling the above mentioned criteria hundred teeth were selected and stored in 01 thymol at 4C until further use
Preparation of solutions
1 Thymol 1grams of thymol crystals were taken and dissolve it in 50ml ethanol After dissolution this solution was made upto 1 litre by distilled water
2 7 Maleic acid 7grams of maleic acid in powder form was dissolve in 100ml of distilled water to get 7 maleic acid
3 18 Etidronic acid 525 sodium hypochlorite For 18 take 75 ml of standard solution and add 175 ml of distilled water in a volumetric to make total 250 ml HEBP Both irrigants were mixed in 11 ratio So 250 ml of etidronic acid were mixed in 250 ml of sodium hypochlorite
Sample Preparation All samples were prepared by a single operator using the following protocol A standardized root length of 16mm was measured with the help of a Vernier caliper After standardization the teeth were decoronated with diamond disc in slow speed hand piece Access opening was performed using diamond round bur attached to high speed handpiece DG The canal was explored using a 10 K-file MaileferDentsply until its tip became visible at the apical foramen Then the working length was established as 1 mm shorter than the anatomical apical foramen After that the apex was sealed by hot glue to simulate the in-vivo closed apex condition Canal was prepared by using ProTaper gold Dentsply-Sirona Switzerland Standard sequence of files were used Shaping files SX S1 S2 and finishing files F1 F2 and F3 were used A 30 guage side vented needle was used for irrigating 525 NaOCl after every consecutive files After cleaning and shaping with the above mentioned files all teeth were divided into five groups
Group Allocation The samples were randomly allocated into five groups Four experimental and one control group A computer-generated sheet MS Excel was used for randomization
Group 1 Ethylene diamine tetra acetic acid EDTA n 20 Group 2 SmearOFF n 20 Group 3 Maleic acid MA n 20 Group 4 Etidronic acid Hypochlorite HEBP NaOCl n 20 Group 5 Saline n20
In each group final irrigation protocol would be as follows
1 Group 1 EDTA 525 NaOCl was used during instrumentation and 5ml of EDTA used for 1min as a final rinse
2 Group 2 smearOFF 525 NaOCl was during instrumentation and 5ml of smearOFF as a final rinse
3 Group 3 Maleic acid 525 NaOCl was during instrumentation and 5ml MA for 1 min as a final rinse was used
4 Group 4 Etidronic acid hypochlorite 11 mixture of 18 HEBP 525 NaOCL was used during instrumentation and the same mixture as a final rinse for 1min
4 Group 5 Saline 09 solution was used during instrumentation and as a final rinse for 1min
The above mentioned experimental groups Group 1 EDTA Group 2 SmearOFF Group 3 MA Group 4 HEBPNaOCl were rinsed with saline to create an isotonic environment After final irrigation all the canals were dried with absorbent paper points From here all samples were divided into two groups sealer penetration and dentin erosion
Sample preparation for sealer penetration
From each experimental and control group teeth were randomly selected and obturated using warm vertical condensation technique After the canals had been dried obturation was performed using warm vertical condensation technique using AH plus sealer The pre-fitted cone was lightly coated with AH plus sealer and placed into the canal then a heated plugger was activated and placed to a point 4-5 mm short of the working length and removed the coronal portion of master cone Next down-pack was performed The remaining root canal was backfilled by using an injectable gutta-percha system EQ-V and vertical compaction was performed Coronal part was sealed with Glass ionomer cement Samples were kept at 37 C and 100 humidity for 7 days in an incubator to allow complete setting of the sealer After 7 days the samples were taken out from incubator The teeth were then embedded in epoxy resin moulds to form resin blocks of uniform dimensions
Slides preparation After the resin was completely set the samples were transversely sectioned at 2mm apical third 5 mm middle third and 8 mm coronal third from the apex with the help of 03 mm blade used in diamond cutting saw Leco VC-50 Three sections with the thickness of 1mm each were obtained Finishing was done by the help of silicone carbide sand paper and polishing was done using polishing machine To remove the in organic debris the specimens were cleaned in a bath with 15 EDTA for 2 minutes and then 3 NaOCl for 2 minutes Samples were placed in sunlight for 24 hours inorder to have moisture free samples
Analysis of sealer penetration into dentinal tubules
Sectioned teeth were marked at 2mm 5mm and 8mm Then specimens were mounted on metallic stubs and titanium-sputtered in Auto Fine Coater JEC-3000FC Coating was done on 20mA current for 30 seconds Under scanning electron microscope SEM JAPAN model no JSM-IT 100 softwareIn touch scope photomicrographs were taken A blind independent observer examined samples for dentinal tubule penetration of sealers at three levels - 25 and 8 mm from the root apex Of each sample one photomicrograph most representative of the section was taken from root-sealer interface at a magnification of 550x On each of these photomicrographs the minimum and maximum depth of sealer penetration in the tubules was measured
Sample preparation for Dentin erosion
From each experimental groups 50 teeth were randomly selected After performing cleaning and shaping all the canals were dried with absorbent paper points Two longitudinal grooves were prepared on the buccal and lingual surfaces of each root using a diamond disc without penetrating the canals The roots were split into two halves using chisel and mallet The half containing the most visible part of the canal was taken for evaluation Then the samples were marked at 2mm apical third 5mm middle third and 8 mm coronal third from the apex
Analysis of Dentin erosion
Coating of the samples was done with platinum coater for evaluation under SEM Then the samples were examined by SEM at x2000 magnification Photomicrographs were taken at each third Scoring of photomicrographs were done according to Torabinejad criteria by two independent observers After that EDX analysis was done to determine total content of calcium and phophorus and the alteration in Ca P caused by various irrigants
METHODOLOGY
Extracted permanent premolars were collected from the department of Oral and maxillofacial surgery at Dow Dental College DDCDUHS and Dr Ishrat-ul-Ebad Khan Institute of Oral Health Sciences DIKIOHS DUHS Teeth were cleaned with the help of ultrasonic scaler for any visible debrissoft tissue remnants and calculus and later examined under dental operating microscope for any visible crack or fracture Teeth with presenting fracture craze lines developmental defects were discarded in accordance to the exclusion criteria Digital periapical radiographs PA at three different angulations 45 90 and 120 were taken to confirm the presence of a single straight canal within the root After fulfilling the above mentioned criteria hundred teeth were selected and stored in 01 thymol at 4C until further use
Preparation of solutions
1 Thymol 1grams of thymol crystals were taken and dissolve it in 50ml ethanol After dissolution this solution was made upto 1 litre by distilled water
2 7 Maleic acid 7grams of maleic acid in powder form was dissolve in 100ml of distilled water to get 7 maleic acid
3 18 Etidronic acid 525 sodium hypochlorite For 18 take 75 ml of standard solution and add 175 ml of distilled water in a volumetric to make total 250 ml HEBP Both irrigants were mixed in 11 ratio So 250 ml of etidronic acid were mixed in 250 ml of sodium hypochlorite
Sample Preparation All samples were prepared by a single operator using the following protocol A standardized root length of 16mm was measured with the help of a Vernier caliper After standardization the teeth were decoronated with diamond disc in slow speed hand piece Access opening was performed using diamond round bur attached to high speed handpiece DG The canal was explored using a 10 K-file MaileferDentsply until its tip became visible at the apical foramen Then the working length was established as 1 mm shorter than the anatomical apical foramen After that the apex was sealed by hot glue to simulate the in-vivo closed apex condition Canal was prepared by using ProTaper gold Dentsply-Sirona Switzerland Standard sequence of files were used Shaping files SX S1 S2 and finishing files F1 F2 and F3 were used A 30 guage side vented needle was used for irrigating 525 NaOCl after every consecutive files After cleaning and shaping with the above mentioned files all teeth were divided into five groups
Group Allocation The samples were randomly allocated into five groups Four experimental and one control group A computer-generated sheet MS Excel was used for randomization
Group 1 Ethylene diamine tetra acetic acid EDTA n 20 Group 2 SmearOFF n 20 Group 3 Maleic acid MA n 20 Group 4 Etidronic acid Hypochlorite HEBP NaOCl n 20 Group 5 Saline n20
In each group final irrigation protocol would be as follows
1 Group 1 EDTA 525 NaOCl was used during instrumentation and 5ml of EDTA used for 1min as a final rinse
2 Group 2 smearOFF 525 NaOCl was during instrumentation and 5ml of smearOFF as a final rinse
3 Group 3 Maleic acid 525 NaOCl was during instrumentation and 5ml MA for 1 min as a final rinse was used
4 Group 4 Etidronic acid hypochlorite 11 mixture of 18 HEBP 525 NaOCL was used during instrumentation and the same mixture as a final rinse for 1min
4 Group 5 Saline 09 solution was used during instrumentation and as a final rinse for 1min
The above mentioned experimental groups Group 1 EDTA Group 2 SmearOFF Group 3 MA Group 4 HEBPNaOCl were rinsed with saline to create an isotonic environment After final irrigation all the canals were dried with absorbent paper points From here all samples were divided into two groups sealer penetration and dentin erosion
Sample preparation for sealer penetration
From each experimental and control group teeth were randomly selected and obturated using warm vertical condensation technique After the canals had been dried obturation was performed using warm vertical condensation technique using AH plus sealer The pre-fitted cone was lightly coated with AH plus sealer and placed into the canal then a heated plugger was activated and placed to a point 4-5 mm short of the working length and removed the coronal portion of master cone Next down-pack was performed The remaining root canal was backfilled by using an injectable gutta-percha system EQ-V and vertical compaction was performed Coronal part was sealed with Glass ionomer cement Samples were kept at 37 C and 100 humidity for 7 days in an incubator to allow complete setting of the sealer After 7 days the samples were taken out from incubator The teeth were then embedded in epoxy resin moulds to form resin blocks of uniform dimensions
Slides preparation After the resin was completely set the samples were transversely sectioned at 2mm apical third 5 mm middle third and 8 mm coronal third from the apex with the help of 03 mm blade used in diamond cutting saw Leco VC-50 Three sections with the thickness of 1mm each were obtained Finishing was done by the help of silicone carbide sand paper and polishing was done using polishing machine To remove the in organic debris the specimens were cleaned in a bath with 15 EDTA for 2 minutes and then 3 NaOCl for 2 minutes Samples were placed in sunlight for 24 hours inorder to have moisture free samples
Analysis of sealer penetration into dentinal tubules
Sectioned teeth were marked at 2mm 5mm and 8mm Then specimens were mounted on metallic stubs and titanium-sputtered in Auto Fine Coater JEC-3000FC Coating was done on 20mA current for 30 seconds Under scanning electron microscope SEM JAPAN model no JSM-IT 100 softwareIn touch scope photomicrographs were taken A blind independent observer examined samples for dentinal tubule penetration of sealers at three levels - 25 and 8 mm from the root apex Of each sample one photomicrograph most representative of the section was taken from root-sealer interface at a magnification of 550x On each of these photomicrographs the minimum and maximum depth of sealer penetration in the tubules was measured
Sample preparation for Dentin erosion
From each experimental groups 50 teeth were randomly selected After performing cleaning and shaping all the canals were dried with absorbent paper points Two longitudinal grooves were prepared on the buccal and lingual surfaces of each root using a diamond disc without penetrating the canals The roots were split into two halves using chisel and mallet The half containing the most visible part of the canal was taken for evaluation Then the samples were marked at 2mm apical third 5mm middle third and 8 mm coronal third from the apex
Analysis of Dentin erosion
Coating of the samples was done with platinum coater for evaluation under SEM Then the samples were examined by SEM at x2000 magnification Photomicrographs were taken at each third Scoring of photomicrographs were done according to Torabinejad criteria by two independent observers After that EDX analysis was done to determine total content of calcium and phophorus and the alteration in Ca P caused by various irrigants
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?:
True
Is an FDA AA801 Violation?:
None