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Sealers in Chronic Apical Lesions

K

Kahramanmaraş Sütçü İmam University (KSU)

Status

Completed

Conditions

Postoperative Pain
Apical Periodontitis
Periapical Healing

Treatments

Procedure: Root Canal Treatment With Sealapex
Procedure: Root Canal Treatment With AH Plus
Procedure: Root Canal Treatment With MTA Fillapex

Study type

Interventional

Funder types

Other

Identifiers

NCT07339579
KSU-SEALER-AP-2024
51 (22/07/2024) (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 3 patient groups

Sealapex Group
Experimental group
Description:
Participants received standardized single-visit root canal treatment using Sealapex as the root canal sealer during obturation.
Treatment:
Procedure: Root Canal Treatment With Sealapex
MTA Fillapex Group
Experimental group
Description:
Participants received standardized single-visit root canal treatment using MTA Fillapex as the root canal sealer during obturation.
Treatment:
Procedure: Root Canal Treatment With MTA Fillapex
AH Plus Group
Experimental group
Description:
Participants received standardized single-visit root canal treatment using AH Plus as the root canal sealer during obturation.
Treatment:
Procedure: Root Canal Treatment With AH Plus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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