Study Results
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Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2024-01-01
2025-09-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sealapex Group
Participants received standardized single-visit root canal treatment using Sealapex as the root canal sealer during obturation.
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).
MTA Fillapex Group
Participants received standardized single-visit root canal treatment using MTA Fillapex as the root canal sealer during obturation.
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).
AH Plus Group
Participants received standardized single-visit root canal treatment using AH Plus as the root canal sealer during obturation.
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).
Interventions
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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).
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).
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Kahramanmaras Sutcu Imam University
OTHER
Responsible Party
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Aliye Kamalak
Associate Professor
Principal Investigators
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Aliye Kamalak
Role: PRINCIPAL_INVESTIGATOR
Kahramanmaras Sutcu Imam University
Locations
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Kahramanmaraş Sutcu İmam University, Faculty of Dentistry
Kahramanmaraş, onikişubat, Turkey (Türkiye)
Countries
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Other Identifiers
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51 (22/07/2024)
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KSU-SEALER-AP-2024
Identifier Type: -
Identifier Source: org_study_id
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