Sealers in Chronic Apical Lesions

January 5, 2026 updated by: Aliye Kamalak, Kahramanmaras Sutcu Imam University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • onikişubat
      • Kahramanmaraş, onikişubat, Turkey (Türkiye), 46010
        • Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 65 years
  • Patients diagnosed with apical periodontitis
  • Presence of a single-rooted anterior or premolar tooth with a radiographically visible periapical lesion
  • Systemically healthy individuals classified as ASA I or ASA II
  • Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

  • Teeth with root fractures, external resorption, or open apices
  • Calcified canals or severely curved root canals (>30°)
  • Periodontal pocket depth greater than 3 mm
  • Pregnancy
  • Use of antibiotics or analgesics within the previous 7 days
  • History of previous endodontic treatment or retreatment in the study tooth
  • Presence of systemic conditions that could affect healing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sealapex Group
Participants received standardized single-visit root canal treatment using Sealapex as the root canal sealer during obturation.
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).
Experimental: MTA Fillapex Group
Participants received standardized single-visit root canal treatment using MTA Fillapex as the root canal sealer during obturation.
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).
Experimental: AH Plus Group
Participants received standardized single-visit root canal treatment using AH Plus as the root canal sealer during obturation.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity Assessed by Verbal Rating Scale (VRS)
Time Frame: Immediately after treatment, 24 hours, and 72 hours after root canal treatment

Postoperative pain intensity was evaluated using the Verbal Rating Scale (VRS). Patients were asked to verbally rate their pain according to the following categories:

0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain.
Immediately after treatment, 24 hours, and 72 hours after root canal treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periapical Healing Assessed by Cone-Beam Computed Tomography (CBCT)
Time Frame: Baseline and 6 months after treatment

Periapical healing was evaluated using cone-beam computed tomography (CBCT). CBCT images were analyzed to assess changes in periapical lesion size and bone healing by comparing baseline and follow-up scans.

Healing was determined based on reduction or resolution of periapical radiolucency, assessed in coronal, sagittal, and axial sections, and supported by three-dimensional reconstruction.

Image evaluation was performed by blinded examiners using standardized criteria.
Baseline and 6 months after treatment
Periapical Healing Assessed by Periapical Index (PAI)
Time Frame: Baseline and 6 months after treatment

Periapical healing was assessed using the Periapical Index (PAI) based on standardized periapical radiographs.

Radiographic findings were scored according to the five-point PAI scale as follows:

  1. = normal periapical structures,
  2. = small changes in bone structure,
  3. = changes in bone structure with some mineral loss,
  4. = periodontitis with a well-defined radiolucent area, and
  5. = severe apical periodontitis with exacerbating features.

Changes in periapical status were evaluated by comparing baseline and 6-month follow-up images. Radiographic assessments were performed by blinded examiners using standardized evaluation criteria.
Baseline and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Investigators

  • Principal Investigator: Aliye Kamalak, Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSU-SEALER-AP-2024
  • 51 (22/07/2024) (Other Grant/Funding Number: HRU Ethics Committee Approval)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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