Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain

NCT ID: NCT05206214

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2022-09-30

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.

Conditions

Postoperative Pain

Study Design

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

Study Groups

Manual glide path

manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver

Group Type: EXPERIMENTAL

Manual glide path

Intervention Type: PROCEDURE

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.

mechanical glide path

glide path will be established using rotary Ni-Ti files in a reciprocating maneuver

Group Type: EXPERIMENTAL

Mechanical glide path

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Heba A ElAsfouri, AssProfessor

Role: CONTACT

heba.elasfouri@dentistry.cu.edu.eg

+201005276232

Mostafa I Negm

Role: CONTACT

mostafaibrahim923@gmail.com

00201227696110

References

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.

Reference Type: BACKGROUND

PMID: 25886847 (View on PubMed)

Other Identifiers

26-12-2021

Identifier Type: -

Identifier Source: org_study_id