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Completed

NCT Number: NCT05170477

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heba ahmed ElAsfouri

Giza, Dokki, 12611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APICAL PATENCY

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 surgery

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

Primary outcomes

  1. postoperative pain intensity using numerical rating scale

    Time frame: after 6 hours after root canal treatment

    postoperative pain after root canal treatment

  2. postoperative pain intensity using numerical rating scale

    Time frame: after12 hours after root canal treatment

    postoperative pain after root canal treatment

  3. postoperative pain intensity using numerical rating scale

    Time frame: after 24 hours after root canal treatment

    postoperative pain after root canal treatment

  4. postoperative pain intensity using numerical rating scale

    Time frame: after 48 hours after root canal treatment

    postoperative pain after root canal treatment

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Zagazig University

Registry information

Official study title

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

Acronym: patency

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2021
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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