Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain

Effect of Manual Glide Path Versus Mechanical Glide Path Establishment on Endodontic Postoperative Pain. A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Manual glide path; Procedure: Mechanical glide path

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba A ElAsfouri, AssProfessor; Phone Number: +201005276232; Email: heba.elasfouri@dentistry.cu.edu.eg
• Study Contact Backup: Name: Mostafa I Negm; Phone Number: 00201227696110; Email: mostafaibrahim923@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual glide path; manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver	Procedure: Manual glide path; 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.
Experimental: mechanical glide path; glide path will be established using rotary Ni-Ti files in a reciprocating maneuver	Procedure: Mechanical glide path; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	postoperative pain after root canal treatment using VAS	after 4 hours after root canal treatment
postoperative pain	postoperative pain after root canal treatment using VAS	after 6hours after root canal treatment
postoperative pain	postoperative pain after root canal treatment using VAS	after 12hours after root canal treatment
postoperative pain	postoperative pain after root canal treatment using VAS	after 24hours after root canal treatment
postoperative pain	postoperative pain after root canal treatment using VAS	after 48 hours after root canal treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Zagazig University
• Investigators: Study Director: Heba A ElAsfouri, Cairo university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 26-12-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No