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

Çukurova University

Status: Completed

Conditions: Postoperative Pain After Endodontic Treatment

Treatments: Procedure: Root canal treatment with apical patency; Procedure: Root canal treatment without apical patency

Study type: Interventional

Funder types: Other

Identifiers

NCT07233590

10.05.2024/33

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 2 patient groups

Non-Patency Group

Active Comparator group

Description:

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

Treatment:

Procedure: Root canal treatment without apical patency

Patency Group

Experimental group

Description:

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

Treatment:

Procedure: Root canal treatment with apical patency