Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment (patency)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
apical patency
Non-apical surgery
Sponsored by

About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
•1. Patient age between 18-60 years old.
- 2. Both males and females will be included.
- 3. All patients are in a good health without systemic condition.
- 4. The offending tooth is a molar.
- 5. The offending molar is indicated for root canal treatment.
- 6. One molar for every patient.
- 7. All patients will sign an informed consent.
Exclusion Criteria:
1. The offending tooth has previous attempt of pulp therapy or root canal treatment.
- 2. The patient showing any clinical or radiographic evidence of periapical pathosis.
- 3. Patients received analgesics or systemic antibiotic prior to treatment.
- 4. Immunocompromised patients.
- 5. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
- 6. History of cancer with radio or chemotherapy.
- 7. Offending molar with mobility score ≥2.
- 8. Offending molar with pocket depth ≥6mm.
- 9. Immature molars.
- 10. Nonodontogenic pain.
- 11. Patients with more than one tooth requiring endodontic intervention.
Sites / Locations
- Heba ahmed ElAsfouri
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Apical aptency
Non-apical patency
Arm Description
In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically
in Gp B apical patency will not be maintained
Outcomes
Primary Outcome Measures
postoperative pain intensity using numerical rating scale
postoperative pain after root canal treatment
postoperative pain intensity using numerical rating scale
postoperative pain after root canal treatment
postoperative pain intensity using numerical rating scale
postoperative pain after root canal treatment
postoperative pain intensity using numerical rating scale
postoperative pain after root canal treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05170477
First Posted
November 27, 2021
Last Updated
March 14, 2022
Sponsor
Cairo University
Collaborators
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT05170477
Brief Title
Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment
Acronym
patency
Official Title
Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment in Molars With Pulpal Disease. A Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this clinical study is to evaluate the influence of apical patency concept implementation upon postoperative pain following root canal treatment in a single visit approach in molars with pulpal disease.
Detailed Description
All patients will be treated in a single session approach regardless of the group. All molars will be anesthetized either through infiltration in case of maxillary molars or inferior alveolar nerve block in case of mandibular molars using Octocaine 2% with epinephrine 1: 100,000 (Lidocaine HCl, Novocol Pharmaceutical, Ontario, Canada.). Rubber dam will be applied; and access will be opened using Endo access bur.
Canals will be scouted using manual patency file in a watch winding maneuver and then coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. Root canals will be copiously irrigated using 10 ml 2.5% sodium hypochlorite NaOCl (Clorox; Egyptian Company for household bleach, Egypt) delivered using 28 Gauge safety Steri Irrigation Tip (DiaDent Group International, Burnaby, BC, Canada) inserted 3 mm below cementoenamel junction. Working length will be determined using electronic apex locator Root ZX II (J. Morita Mfg. Corp, Kyoto, Japan) and confirmed radiographically using parallel technique with receptor holding device. Canals will be irrigated again with 10ml 1.5% NaOCl, which will be delivered 2mm coronal to apical canal terminus. Irrigation will be hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using yellow tips #20/06 inserted 2mm short of working length for 60 seconds. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland). In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically while in Gp B apical patency will not be maintained. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apical aptency
Arm Type
Experimental
Arm Description
In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically
Arm Title
Non-apical patency
Arm Type
Active Comparator
Arm Description
in Gp B apical patency will not be maintained
Intervention Type
Procedure
Intervention Name(s)
apical patency
Intervention Description
In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.
Intervention Type
Procedure
Intervention Name(s)
Non-apical surgery
Intervention Description
in Gp B apical patency will not be maintained. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration
Primary Outcome Measure Information:
Title
postoperative pain intensity using numerical rating scale
Description
postoperative pain after root canal treatment
Time Frame
after 6 hours after root canal treatment
Title
postoperative pain intensity using numerical rating scale
Description
postoperative pain after root canal treatment
Time Frame
after12 hours after root canal treatment
Title
postoperative pain intensity using numerical rating scale
Description
postoperative pain after root canal treatment
Time Frame
after 24 hours after root canal treatment
Title
postoperative pain intensity using numerical rating scale
Description
postoperative pain after root canal treatment
Time Frame
after 48 hours after root canal treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
•1. Patient age between 18-60 years old.
2. Both males and females will be included.
3. All patients are in a good health without systemic condition.
4. The offending tooth is a molar.
5. The offending molar is indicated for root canal treatment.
6. One molar for every patient.
7. All patients will sign an informed consent.
Exclusion Criteria:
1. The offending tooth has previous attempt of pulp therapy or root canal treatment.
2. The patient showing any clinical or radiographic evidence of periapical pathosis.
3. Patients received analgesics or systemic antibiotic prior to treatment.
4. Immunocompromised patients.
5. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
6. History of cancer with radio or chemotherapy.
7. Offending molar with mobility score ≥2.
8. Offending molar with pocket depth ≥6mm.
9. Immature molars.
10. Nonodontogenic pain.
11. Patients with more than one tooth requiring endodontic intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba A ElAsfouri, AssProfessor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Heba ahmed ElAsfouri
City
Giza
State/Province
Dokki
ZIP/Postal Code
12611
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7561660
Citation
al-Omari MA, Dummer PM. Canal blockage and debris extrusion with eight preparation techniques. J Endod. 1995 Mar;21(3):154-8. doi: 10.1016/s0099-2399(06)80443-7.
Results Reference
background
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Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment
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