The Effect of Apical Patency on Postoperative Pain Following Root Canal Treatment

NCT ID: NCT07233590

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-05
• Study Completion Date: 2025-02-10

Brief Summary

The goal of this randomized controlled clinical trial was to evaluate whether implementing apical patency affects the intensity of postoperative pain after single-visit root canal treatment in asymptomatic, vital, single-rooted teeth.

The main question it aims to answer is:

Does maintaining apical patency by gently extending a #10 K-file 1 mm beyond the working length during canal shaping influence postoperative pain compared with instrumentation confined within the working length?

In the patency group, the working length was determined with an electronic apex locator and radiograph, and then apical patency was maintained by passively extending a #10 K-file 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus.

In the non-patency group, the working length was likewise established with an electronic apex locator and radiograph, but all subsequent instrumentation was confined within the working length and no file was advanced beyond the apical foramen.

In both groups, all other clinical procedures-including anesthesia, rubber dam isolation, access cavity preparation, rotary canal shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation with gutta-percha and epoxy resin-based sealer, and definitive composite restoration-were performed in a single visit using the same protocol. Postoperative pain was recorded on a Numerical Rating Scale (NRS) at 0-6, 6-12, 12-24, 24-36, and 36-48 hours, and analgesic intake within 48 hours was documented.

Conditions

Postoperative Pain After Endodontic Treatment

Study Design

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

Study Groups

Non-Patency Group

Preoperative pain was recorded using a Numerical Rating Scale (NRS) before treatment. All procedures were performed in a single visit by one operator under 3× magnification. Local anesthesia was achieved with 4% articaine containing 1:100,000 epinephrine. After rubber dam isolation, caries and existing restorations were removed and an endodontic access cavity was prepared under copious water cooling using high-speed sterile diamond burs.

The working length was established with an electronic apex locator (Root ZX Mini) and confirmed radiographically. In this group, apical patency was not maintained: after working length determination, all subsequent instrumentation was confined within the working length, and no file was advanced beyond the apical foramen.

Root canals were shaped using the One Curve NiTi rotary system (25/.06 or 35/.04) with a crown-down technique. During shaping, canals were irrigated with a total of 10 mL of 2.5% sodium hypochlorite (2 mL after each shaping step) de

Group Type: ACTIVE_COMPARATOR

Root canal treatment without apical patency

Intervention Type: PROCEDURE

Single-visit root canal treatment of asymptomatic vital single-rooted teeth in which apical patency is not maintained. After working length determination with an electronic apex locator and radiographic confirmation, all subsequent instrumentation is confined within the working length and no file is advanced beyond the apical foramen. All other steps, including anesthesia, rubber dam isolation, access cavity preparation, rotary shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation, and definitive composite restoration, follow the same standardized protocol as in the patency group.

Patency Group

Preoperative pain was recorded using a Numerical Rating Scale (NRS) before treatment. All procedures were performed in a single visit by one operator under 3× magnification. Local anesthesia was achieved with 4% articaine containing 1:100,000 epinephrine. After rubber dam isolation, caries and existing restorations were removed and an endodontic access cavity was prepared under copious water cooling using high-speed sterile diamond burs.

The working length was established with an electronic apex locator (Root ZX Mini) and confirmed radiographically. In this group, apical patency was maintained: a #10 K-file was gently advanced 1 mm beyond the working length at each instrument change to prevent apical blockage, remove accumulated debris, and facilitate irrigant delivery to the apical terminus.

Root canals were shaped using the One Curve NiTi rotary system (25/.06 or 35/.04) with a crown-down technique. During shaping, canals were irrigated with a total of 10 mL of 2.5% sodium hypochl

Group Type: EXPERIMENTAL

Root canal treatment with apical patency

Intervention Type: PROCEDURE

Single-visit root canal treatment of asymptomatic vital single-rooted teeth in which apical patency is maintained. After working length determination with an electronic apex locator and radiographic confirmation, a #10 K-file is gently extended 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus. All other steps, including anesthesia, rubber dam isolation, access cavity preparation, rotary shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation, and definitive composite restoration, follow a standardized protocol.

Interventions

Root canal treatment with apical patency

Single-visit root canal treatment of asymptomatic vital single-rooted teeth in which apical patency is maintained. After working length determination with an electronic apex locator and radiographic confirmation, a #10 K-file is gently extended 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus. All other steps, including anesthesia, rubber dam isolation, access cavity preparation, rotary shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation, and definitive composite restoration, follow a standardized protocol.

Intervention Type: PROCEDURE

Root canal treatment without apical patency

Single-visit root canal treatment of asymptomatic vital single-rooted teeth in which apical patency is not maintained. After working length determination with an electronic apex locator and radiographic confirmation, all subsequent instrumentation is confined within the working length and no file is advanced beyond the apical foramen. All other steps, including anesthesia, rubber dam isolation, access cavity preparation, rotary shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation, and definitive composite restoration, follow the same standardized protocol as in the patency group.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Individuals aged 18-65 years, classified as ASA I or ASA II according to the American Society of Anesthesiologists (ASA), who had not taken analgesics for at least 6 hours prior to treatment.
• Asymptomatic, single-rooted vital teeth without spontaneous pain (including teeth perforated during prosthetic preparation or teeth adjacent to a cyst in an area scheduled for cyst surgery).
• Radiographic evidence of mature apices with no periapical pathology; periodontal probing depth ≤ 3 mm; and gingival health meeting Glickman's criteria.
• Individuals who are literate, able to provide written informed consent, and capable of understanding and using the pain scale.

Exclusion Criteria

• Patients who are pregnant or have a cardiac pacemaker.
• Patients who used antibiotics within the past month or who required antibiotic prophylaxis.
• Presence of extensive restorations in the tooth of interest.
• Patients reporting concurrent pain in adjacent teeth.
• Dental or orofacial pain of non-endodontic origin.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Kübra Gürler

Pricipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adile Şehnaz Yılmaz, DDS, Phd, Professor

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

Cukurova University

Adana, Sarıçam, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Yaylali IE, Demirci GK, Kurnaz S, Celik G, Kaya BU, Tunca YM. Does Maintaining Apical Patency during Instrumentation Increase Postoperative Pain or Flare-up Rate after Nonsurgical Root Canal Treatment? A Systematic Review of Randomized Controlled Trials. J Endod. 2018 Aug;44(8):1228-1236. doi: 10.1016/j.joen.2018.05.002. Epub 2018 Jun 20.

Reference Type: BACKGROUND

PMID: 29935875 (View on PubMed)

Other Identifiers

10.05.2024/33

Identifier Type: -

Identifier Source: org_study_id