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

Postoperative Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170477
• Other study ID #: Endo 27-11-2021
• Status: Completed
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Heba ahmed ElAsfouri	Giza	Dokki

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

al-Omari MA, Dummer PM. Canal blockage and debris extrusion with eight preparation techniques. J Endod. 1995 Mar;21(3):154-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain intensity using numerical rating scale	postoperative pain after root canal treatment	after 6 hours after root canal treatment
Primary	postoperative pain intensity using numerical rating scale	postoperative pain after root canal treatment	after12 hours after root canal treatment
Primary	postoperative pain intensity using numerical rating scale	postoperative pain after root canal treatment	after 24 hours after root canal treatment
Primary	postoperative pain intensity using numerical rating scale	postoperative pain after root canal treatment	after 48 hours after root canal treatment