Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment (patency)

Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment in Molars With Pulpal Disease. A Randomized Controlled Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: apical patency; Procedure: Non-apical surgery

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.

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

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 12611
      • Heba ahmed ElAsfouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apical aptency; In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically	Procedure: apical patency; 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.
Active Comparator: Non-apical patency; in Gp B apical patency will not be maintained	Procedure: Non-apical surgery; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain intensity using numerical rating scale	postoperative pain after root canal treatment	after 6 hours after root canal treatment
postoperative pain intensity using numerical rating scale	postoperative pain after root canal treatment	after12 hours after root canal treatment
postoperative pain intensity using numerical rating scale	postoperative pain after root canal treatment	after 24 hours after root canal treatment
postoperative pain intensity using numerical rating scale	postoperative pain after root canal treatment	after 48 hours after root canal treatment

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: November 27, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 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: Endo 27-11-2021

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