Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual glide path
Mechanical glide path
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patient age above 18-70 years old.
- Both males and females will be included.
- All patients are in a good health without systemic condition.
- The offending tooth is a molar.
- The offending molar is indicated for root canal treatment.
- One molar for every patient.
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Manual glide path
mechanical glide path
Arm Description
manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver
glide path will be established using rotary Ni-Ti files in a reciprocating maneuver
Outcomes
Primary Outcome Measures
postoperative pain
postoperative pain after root canal treatment using VAS
postoperative pain
postoperative pain after root canal treatment using VAS
postoperative pain
postoperative pain after root canal treatment using VAS
postoperative pain
postoperative pain after root canal treatment using VAS
postoperative pain
postoperative pain after root canal treatment using VAS
Secondary Outcome Measures
Full Information
NCT ID
NCT05206214
First Posted
December 26, 2021
Last Updated
January 11, 2022
Sponsor
Cairo University
Collaborators
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT05206214
Brief Title
Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain
Official Title
Effect of Manual Glide Path Versus Mechanical Glide Path Establishment on Endodontic Postoperative Pain. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
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
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.
In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. 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 were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds.
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.
In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. 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 were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 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). 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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual glide path
Arm Type
Experimental
Arm Description
manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver
Arm Title
mechanical glide path
Arm Type
Experimental
Arm Description
glide path will be established using rotary Ni-Ti files in a reciprocating maneuver
Intervention Type
Procedure
Intervention Name(s)
Manual glide path
Intervention Description
manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. . Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone.
Intervention Type
Procedure
Intervention Name(s)
Mechanical glide path
Intervention Description
glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone.
Primary Outcome Measure Information:
Title
postoperative pain
Description
postoperative pain after root canal treatment using VAS
Time Frame
after 4 hours after root canal treatment
Title
postoperative pain
Description
postoperative pain after root canal treatment using VAS
Time Frame
after 6hours after root canal treatment
Title
postoperative pain
Description
postoperative pain after root canal treatment using VAS
Time Frame
after 12hours after root canal treatment
Title
postoperative pain
Description
postoperative pain after root canal treatment using VAS
Time Frame
after 24hours after root canal treatment
Title
postoperative pain
Description
postoperative pain after root canal treatment using VAS
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
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient age above 18-70 years old.
Both males and females will be included.
All patients are in a good health without systemic condition.
The offending tooth is a molar.
The offending molar is indicated for root canal treatment.
One molar for every patient.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba A ElAsfouri, AssProfessor
Phone
+201005276232
Email
heba.elasfouri@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa I Negm
Phone
00201227696110
Email
mostafaibrahim923@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba A ElAsfouri
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25886847
Citation
Wu H, Peng C, Bai Y, Hu X, Wang L, Li C. Shaping ability of ProTaper Universal, WaveOne and ProTaper Next in simulated L-shaped and S-shaped root canals. BMC Oral Health. 2015 Mar 1;15:27. doi: 10.1186/s12903-015-0012-z.
Results Reference
background
Learn more about this trial
Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain
We'll reach out to this number within 24 hrs