Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain
Sponsor:
Sinai University
Organization:
Sinai University
Study Overview
Official Title:
The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain In Single Rooted Mandibular Premolar Teeth A Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 trial will aim to evaluate postoperative pain in terms of incidence and intensity and the frequency rate of analgesic intake in patients with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis after single-visit endodontic treatment of single rooted mandibular premolars using PUI or XPF Fanta AF max file and dynamic manual agitation in the final irrigation protocol in a randomized clinical trial Postoperative pain will be assessed using a VRS 6 12 24 48 72 hours and I week after completion of root canal treatment
Detailed Description:
Selection of cases
A total number of sixty-four patients in the 18-40 age range will be enrolled for the study from the outpatient clinic of restorative department of Sinai university Kantara branch The selected patients will have a carious pulp exposure that will be selected according to the inclusion and exclusion criteria to participate in this study the procedure possible discomfort and benefits will be explained to the patients Informed consent will be obtained from the patients prior to study which includes root canal treatment in a single visit of single rooted mandibular premolar teeth with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis and both verbal and written consent is advisable Before initiation of treatment the whole procedural steps will be explained to the patients Then the patients will sign an informed consent form
Sample size
Sample size calculation was performed using GPower version 3197 based on the results of a previous study 13 A power analysis was designed to have adequate power to apply a two-sided statistical test to reject the null hypothesis that there is no difference between groups By adopting an alpha level of 005 and a beta of 02 ie power 80 and an effect size d of 055 calculated based on the results of a previous study The predicted sample size n will be 64 ie 16 samples per group To detect for different postoperative pain between groups Patient Selection Criteria Systemically healthy patients with single rooted mandibular premolar teeth with oval canals diagnosed with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis will be included in the study The diagnosis will be based on clinical findings including pain level and its characteristics intensity duration frequency and provoking and relieving factors An intraoral clinical examination will be carried out using a diagnostic mirror and probe The presence of extensive caries or recurrent caries with large restoration will be identified Radiographic examination will be performed with a periapical film Dental film speed D size 2 Kodak Co NY USA using the parallel technique to evaluate tooth structure deep caries proximity number of canals previous defective restorations periapical status and periodontal support Restorable teeth with normal periodontal scoring index 2 Absence of mobility tenderness on percussion associated with normal periapical radiograph or slight widening of periodontal membrane space will be considered as inclusion criteria14 The exclusion criteria will be included patients suffering from any significant systemic disorder patients incapable of providing informed self-consent or below the age of 18 patients over the age of 45 patients having a mandibular premolar with periapical involvement or more than one canal Teeth with pulp necrosis open apices no tenderness to percussion periodontal involvement palpation of adjacent soft tissues Presence of sinus tract Retreated cases Pregnant women patients who will be allergic to local anesthetic agents and patients who will take medications antibiotics analgesics or anti-inflammatory drugs seven days before the procedure13
All participants will be informed about the study and their consent will be obtained before treatment A list for random participant assignment will be generated by a randomization software This randomization will be performed by an operator not involved in the study An ethyl chloride cold pulp tester will be used to detect the affected tooths response and the adjacent and contralateral teeth used as control to ensure that the tester will work properly and that the participants responds adequately The preoperative pain level will be assessed by giving each participant a pain scale chart VRS to record the pain level before any intervention Clinical and radiographic data of each patient will be attached to their clinical notes and analyzed by 2 experienced endodontists
Preparation of the patient - Before the preparation and restoration visit all patients will be subjected to full mouth scaling and will be given proper oral hygiene instruction
Clinical Steps
All root canal procedures will be performed in a single visit by an experienced clinician An inferior alveolar nerve block 4 Mepivicaine HCl 1100000 Adrenaline will be used to anaesthetize the tooth After the removal of decay and restoration buildup a rubber dam Sanctuary Dental Dam Systems Ipoh Malaysia will be applied and an access cavity will be performed using a size 2 round bur Dentsply Maillefer Ballaigues Switzerland and an Endo-Z bur Dentsply Maillefer Canal patency will be confirmed with a 15 K file Dentsply Maillefer The working length set at 1 mm short of the radiographic apex will be determined using an electronic apex locator Root ZX J Morita Tokyo Japan and then will be confirmed radiographically The Protaper Next PTN rotary system Dentsply Maillefer will be used to mechanically prepare the root canals in a crown-down technique using an endodontic motor XSmart Dentsply Maillefer Ballaigues Switzerland with an adjusted torque of 2 Ncm and speed of 300 rpm according to the manufacturers instructions PTN rotary system Dentsply Maillefer will be used as follows X1 X2 X3 followed by X4 as the master apical file All files will be used in a pecking motion to the full working length Irrigation of the root canals will be performed using 3 ml of 25 NaOCl solution delivered by a plastic disposable syringe S-S disposable syringe Sung Shim Medical Bucheon Korea with a 30-gauge needle NaviTip Ultradent UT USA after each file for 1 minute Then it will be introduced passively without forcefully dispensing the irrigant and placed 2 mm from the working length Participants will be divided into four groups 16 participants for each group according to the final irrigation protocol as follow
Group 1 XP-endo Finisher Group 2 Passive Ultrasonic Irrigation Group 3 Fanta AF max file Group 4 Manual dynamic agitation Irrigant replenishment will be performed in all groups to remove loose debris Afterwards agitation and replenishment cycles will be repeated twice The canals will be finally flushed with 3 ml of saline for 1 minute Sterile paper points Meta Biomed Cheongju City Korea that correspond to the master cone size will be used to dry the canals The canals will be obturated using lateral compaction technique Then the access cavity will be sealed with temporary filling material of sufficient thickness A postoperative radiograph will be taken and each patient will be instructed to take 400 mg of ibuprofen every 6 hours in case of severe pain 14-15 post operative evaluation
Patients will be informed about the possible development of pain Postoperative pain will be assessed using a VRS 6 12 24 48 72 hours and I week after completion of root canal treatment The VRS consisted of a four-step pain scale using a continuous 0-3 point scale 16-17 No pain 0 the treated tooth felt normal Patients did not have any pain or discomfort mild 1 recognizable not discomforting moderate 2 discomforting but bearable and severe 3 considerable discomfort difficult to bear Each participant will be given a chart to record the level of postoperative pain and the frequency rate of the analgesic intake
Statistical analysis - The collected data will be tabulated and statistically analyzed using SPSS program Statistical Package for Social Sciences software version 230 Descriptive statistics will be done for numerical parametric data as meanSD standard deviation and minimum maximum of the range and for numerical non parametric data as median and 1st 3rd inter-quartile range while they will be done for categorical data as number and percentage Inferential analyses will be done for quantitative variables using independent t-test in cases of two independent groups with parametric data and Mann Whitney U in cases of two independent groups with non-parametric data
Inferential analyses will be done for qualitative data using Chi square test for independent groups The level of significance will be taken at P value 0050 is significant otherwise is non-significant The p-value is a statistical measure for the probability that the results observed in a study could have occurred by chance
A total number of sixty-four patients in the 18-40 age range will be enrolled for the study from the outpatient clinic of restorative department of Sinai university Kantara branch The selected patients will have a carious pulp exposure that will be selected according to the inclusion and exclusion criteria to participate in this study the procedure possible discomfort and benefits will be explained to the patients Informed consent will be obtained from the patients prior to study which includes root canal treatment in a single visit of single rooted mandibular premolar teeth with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis and both verbal and written consent is advisable Before initiation of treatment the whole procedural steps will be explained to the patients Then the patients will sign an informed consent form
Sample size
Sample size calculation was performed using GPower version 3197 based on the results of a previous study 13 A power analysis was designed to have adequate power to apply a two-sided statistical test to reject the null hypothesis that there is no difference between groups By adopting an alpha level of 005 and a beta of 02 ie power 80 and an effect size d of 055 calculated based on the results of a previous study The predicted sample size n will be 64 ie 16 samples per group To detect for different postoperative pain between groups Patient Selection Criteria Systemically healthy patients with single rooted mandibular premolar teeth with oval canals diagnosed with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis will be included in the study The diagnosis will be based on clinical findings including pain level and its characteristics intensity duration frequency and provoking and relieving factors An intraoral clinical examination will be carried out using a diagnostic mirror and probe The presence of extensive caries or recurrent caries with large restoration will be identified Radiographic examination will be performed with a periapical film Dental film speed D size 2 Kodak Co NY USA using the parallel technique to evaluate tooth structure deep caries proximity number of canals previous defective restorations periapical status and periodontal support Restorable teeth with normal periodontal scoring index 2 Absence of mobility tenderness on percussion associated with normal periapical radiograph or slight widening of periodontal membrane space will be considered as inclusion criteria14 The exclusion criteria will be included patients suffering from any significant systemic disorder patients incapable of providing informed self-consent or below the age of 18 patients over the age of 45 patients having a mandibular premolar with periapical involvement or more than one canal Teeth with pulp necrosis open apices no tenderness to percussion periodontal involvement palpation of adjacent soft tissues Presence of sinus tract Retreated cases Pregnant women patients who will be allergic to local anesthetic agents and patients who will take medications antibiotics analgesics or anti-inflammatory drugs seven days before the procedure13
All participants will be informed about the study and their consent will be obtained before treatment A list for random participant assignment will be generated by a randomization software This randomization will be performed by an operator not involved in the study An ethyl chloride cold pulp tester will be used to detect the affected tooths response and the adjacent and contralateral teeth used as control to ensure that the tester will work properly and that the participants responds adequately The preoperative pain level will be assessed by giving each participant a pain scale chart VRS to record the pain level before any intervention Clinical and radiographic data of each patient will be attached to their clinical notes and analyzed by 2 experienced endodontists
Preparation of the patient - Before the preparation and restoration visit all patients will be subjected to full mouth scaling and will be given proper oral hygiene instruction
Clinical Steps
All root canal procedures will be performed in a single visit by an experienced clinician An inferior alveolar nerve block 4 Mepivicaine HCl 1100000 Adrenaline will be used to anaesthetize the tooth After the removal of decay and restoration buildup a rubber dam Sanctuary Dental Dam Systems Ipoh Malaysia will be applied and an access cavity will be performed using a size 2 round bur Dentsply Maillefer Ballaigues Switzerland and an Endo-Z bur Dentsply Maillefer Canal patency will be confirmed with a 15 K file Dentsply Maillefer The working length set at 1 mm short of the radiographic apex will be determined using an electronic apex locator Root ZX J Morita Tokyo Japan and then will be confirmed radiographically The Protaper Next PTN rotary system Dentsply Maillefer will be used to mechanically prepare the root canals in a crown-down technique using an endodontic motor XSmart Dentsply Maillefer Ballaigues Switzerland with an adjusted torque of 2 Ncm and speed of 300 rpm according to the manufacturers instructions PTN rotary system Dentsply Maillefer will be used as follows X1 X2 X3 followed by X4 as the master apical file All files will be used in a pecking motion to the full working length Irrigation of the root canals will be performed using 3 ml of 25 NaOCl solution delivered by a plastic disposable syringe S-S disposable syringe Sung Shim Medical Bucheon Korea with a 30-gauge needle NaviTip Ultradent UT USA after each file for 1 minute Then it will be introduced passively without forcefully dispensing the irrigant and placed 2 mm from the working length Participants will be divided into four groups 16 participants for each group according to the final irrigation protocol as follow
Group 1 XP-endo Finisher Group 2 Passive Ultrasonic Irrigation Group 3 Fanta AF max file Group 4 Manual dynamic agitation Irrigant replenishment will be performed in all groups to remove loose debris Afterwards agitation and replenishment cycles will be repeated twice The canals will be finally flushed with 3 ml of saline for 1 minute Sterile paper points Meta Biomed Cheongju City Korea that correspond to the master cone size will be used to dry the canals The canals will be obturated using lateral compaction technique Then the access cavity will be sealed with temporary filling material of sufficient thickness A postoperative radiograph will be taken and each patient will be instructed to take 400 mg of ibuprofen every 6 hours in case of severe pain 14-15 post operative evaluation
Patients will be informed about the possible development of pain Postoperative pain will be assessed using a VRS 6 12 24 48 72 hours and I week after completion of root canal treatment The VRS consisted of a four-step pain scale using a continuous 0-3 point scale 16-17 No pain 0 the treated tooth felt normal Patients did not have any pain or discomfort mild 1 recognizable not discomforting moderate 2 discomforting but bearable and severe 3 considerable discomfort difficult to bear Each participant will be given a chart to record the level of postoperative pain and the frequency rate of the analgesic intake
Statistical analysis - The collected data will be tabulated and statistically analyzed using SPSS program Statistical Package for Social Sciences software version 230 Descriptive statistics will be done for numerical parametric data as meanSD standard deviation and minimum maximum of the range and for numerical non parametric data as median and 1st 3rd inter-quartile range while they will be done for categorical data as number and percentage Inferential analyses will be done for quantitative variables using independent t-test in cases of two independent groups with parametric data and Mann Whitney U in cases of two independent groups with non-parametric data
Inferential analyses will be done for qualitative data using Chi square test for independent groups The level of significance will be taken at P value 0050 is significant otherwise is non-significant The p-value is a statistical measure for the probability that the results observed in a study could have occurred by chance
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