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

NCT ID: NCT05170477

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2021-12-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Apical aptency

In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically

Group Type: EXPERIMENTAL

apical patency

Intervention Type: PROCEDURE

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 patency

in Gp B apical patency will not be maintained

Group Type: ACTIVE_COMPARATOR

Non-apical surgery

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Elasfouri

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba A ElAsfouri, AssProfessor

Role: STUDY_DIRECTOR

Cairo University

Locations

Heba ahmed ElAsfouri

Giza, Dokki, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 7561660 (View on PubMed)

Other Identifiers

Endo 27-11-2021

Identifier Type: -

Identifier Source: org_study_id