Sealers in Chronic Apical Lesions

NCT07339579 | Completed

• 2 other identifiers: KSU-SEALER-AP-202451 (22/07/2024)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apical Periodontitis; Postoperative Pain; Periapical Healing

Keywords

Root Canal Sealer; AH Plus; MTA Fillapex; Sealapex; Root Canal Treatment; Periapical Index; Cone-Beam Computed Tomography; Postoperative Pain; Endodontics

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity Assessed by Verbal Rating Scale (VRS)

  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 Outcomes (2)

• Periapical Healing Assessed by Cone-Beam Computed Tomography (CBCT)

  Baseline and 6 months after treatment

• Periapical Healing Assessed by Periapical Index (PAI)

  Baseline and 6 months after treatment

Study Arms (3)

Sealapex Group

EXPERIMENTAL

Participants received standardized single-visit root canal treatment using Sealapex as the root canal sealer during obturation.

Procedure: Root Canal Treatment With Sealapex

MTA Fillapex Group

EXPERIMENTAL

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

AH Plus Group

EXPERIMENTAL

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

Interventions

Root Canal Treatment With MTA Fillapex PROCEDURE

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).

MTA Fillapex Group

Root Canal Treatment With Sealapex PROCEDURE

Root canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with Sealapex (calcium hydroxide-based sealer).

Sealapex Group

Root Canal Treatment With AH Plus PROCEDURE

Root canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with AH Plus (epoxy resin-based sealer).

AH Plus Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sutcu İmam University, Faculty of Dentistry

Kahramanmaraş, onikişubat, 46010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Interventions

Sealapex; TheraCal

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Aliye Kamalak

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiographic and CBCT images were anonymized and evaluated by independent examiners who were blinded to the intervention groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomly assigned to one of three parallel intervention groups according to the root canal sealer used during treatment.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)