NCT07339579

Sealers in Chronic Apical Lesions

Evaluation of the Effects of Root Canal Sealers on Postoperative Pain and Radiographic Healing in Patients With Apical Periodontitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Kahramanmaras Sutcu Imam University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical study evaluated whether different root canal sealers influence postoperative pain and early periapical healing in patients with apical periodontitis. A total of 72 adult patients with single-rooted teeth diagnosed with chronic apical periodontitis received standardized root canal treatment and were randomly assigned to one of three commonly used sealers: AH Plus, MTA Fillapex, or Sealapex. Postoperative pain was recorded using a verbal pain rating scale immediately after treatment and at 24 and 72 hours. Periapical healing was assessed at baseline and after six months using periapical radiographs and cone-beam computed tomography (CBCT). The purpose of this study was to determine whether the type of root canal sealer affects patient comfort after treatment and the early healing of periapical tissues. Understanding these outcomes may help clinicians choose appropriate materials and better inform patients about expected pain and healing after root canal therapy.

Detailed description

This study was designed as a single-center, randomized, controlled clinical trial to compare the effects of three different root canal sealers on postoperative pain and radiographic periapical healing in patients with apical periodontitis. A total of 72 patients aged 18-65 years with single-rooted anterior or premolar teeth diagnosed with chronic apical periodontitis were enrolled. Patients with systemic diseases beyond ASA I-II status, previous endodontic treatment, root fractures, severe canal curvature, open apices, or recent use of antibiotics or analgesics were excluded to ensure standardization. After obtaining informed consent, participants were randomly allocated into three equal groups according to the sealer used for root canal obturation: Sealapex (calcium hydroxide-based sealer), MTA Fillapex (MTA-containing salicylate resin-based sealer), or AH Plus (epoxy resin-based sealer). All root canal treatments were performed in a single visit under rubber dam isolation by the same experienced endodontist to eliminate inter-operator variability. Root canals were prepared using a standardized nickel-titanium instrumentation system and irrigated with sodium hypochlorite and EDTA according to a uniform protocol. Obturation was completed using the lateral condensation technique with gutta-percha and the assigned sealer. Permanent composite restorations were placed after obturation. Postoperative pain was assessed using the Verbal Rating Scale (VRS) immediately after treatment and at 24 and 72 hours. Patients were instructed not to use analgesics unless severe pain occurred. Radiographic evaluation of periapical healing was performed using periapical radiographs and cone-beam computed tomography (CBCT) at baseline and at the 6-month follow-up. Healing was assessed using the Periapical Index (PAI) and three-dimensional CBCT evaluation to detect early changes in lesion size and bone repair. The primary objective of the study was to compare postoperative pain levels among the three sealer groups. Secondary objectives included evaluation of early periapical healing using both two-dimensional and three-dimensional imaging methods. This study aimed to clarify whether sealer composition influences short-term clinical outcomes when root canal treatment is performed under standardized conditions. The findings may contribute to evidence-based material selection and improved patient counseling regarding postoperative pain and healing expectations.

Conditions

• Apical Periodontitis
• Postoperative Pain
• Periapical Healing

Interventions

Type	Name	Description
PROCEDURE	Root Canal Treatment With Sealapex	Root canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with Sealapex (calcium hydroxide-based sealer).
PROCEDURE	Root Canal Treatment With MTA Fillapex	Root canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with MTA Fillapex (MTA-containing salicylate resin-based sealer).
PROCEDURE	Root Canal Treatment With AH Plus	Root canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with AH Plus (epoxy resin-based sealer).

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: Turkey (Türkiye)