Evaluation of Postoperative Pain and Lesion Healing in Periapical Lesion-Affected Teeth Obturated With Different Root Canal Sealers

NCT07307807 | Active Not Recruiting

• 1 other identifier: 2025/14-03(KA-25010)
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The root canal treatment of volunteers with asymptomatic apical periodontitis will be completed using TotalFill BC and AH Plus root canal sealers, and postoperative pain as well as healing will be comparatively evaluated through radiographic follow-ups at predetermined time intervals.

Conditions

Root Canal Obturation; Apical Periodontitis

Keywords

AH Plus; TotalFill BC Sealer; Postoperative pain; Fractal analysis; Visual Analog Scale (VAS)

Outcome Measures

Primary Outcomes (2)

• Fractal analysis

  In this study, fractal analysis of each sample will be performed using the box-counting method.

  6. month

• VAS scala

  Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, on a form using the Visual Analog Scale (VAS). One week after treatment, volunteers will be contacted by telephone, and the pain scores indicated on the pain assessment forms will be obtained and recorded in the patient files.

  6.,12.,24.,36.,48.,72. hours and 1 week

Study Arms (4)

AH Plus and PAI 2-3

EXPERIMENTAL

Teeth with PAI scores of 2 and 3 that were obturated with AH Plus and completed in a single visit.

Procedure: AH Plus and PAI 2-3

AH Plus and PAI 4

EXPERIMENTAL

Teeth with a PAI score of 4 that were obturated with AH Plus and completed in a single visit.

Procedure: AH Plus and PAI 4

TotalFill BC Sealer and PAI 2-3

EXPERIMENTAL

Teeth with PAI scores of 2 and 3 obturated with TotalFill BC and completed in a single visit.

Procedure: TotalFill BC Sealer and PAI 2-3

TotalFill BC Sealer and PAI 4

EXPERIMENTAL

Teeth with a PAI score of 4 obturated with TotalFill BC and completed in a single visit.

Procedure: TotalFill BC Sealer and PAI 4

Interventions

AH Plus and PAI 2-3 PROCEDURE

The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings. Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

AH Plus and PAI 2-3

AH Plus and PAI 4 PROCEDURE

The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings. Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated

AH Plus and PAI 4

TotalFill BC Sealer and PAI 2-3 PROCEDURE

The TotalFill BC root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings. Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

TotalFill BC Sealer and PAI 2-3

TotalFill BC Sealer and PAI 4 PROCEDURE

The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings. Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

TotalFill BC Sealer and PAI 4

Eligibility Criteria

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

You may qualify if:

• Healthy individuals aged between 18 and 60 years with no systemic diseases
• Teeth with periapical lesions (apical periodontitis) that have not undergone previous root canal treatment
• Single-rooted maxillary and mandibular teeth
• Teeth with PAI scores of 2, 3, and 4 according to the PAI classification
• Teeth without a sinus tract or acute apical abscess
• Patients who voluntarily agree to participate in the study and attend follow-up visits
• Teeth with sufficient remaining tooth structure to allow restoration with a direct restoration after root canal treatment -

You may not qualify if:

• Patients who have used antibiotics, analgesics, or anti-inflammatory drugs within the last 7 days
• Pregnant or breastfeeding patients
• Patients with traumatic malocclusion
• Patients without occlusal contact
• Teeth with root resorption, open apices, or calcification
• Teeth presenting gingival recession greater than 3 mm, deep periodontal pockets, or mobility
• Teeth with root fractures or cracks
• Presence of an adjacent tooth requiring endodontic treatment that may cause referred pain
• Multirooted teeth
• Teeth with a PAI score of 5
• Teeth requiring restorations such as endocrowns, onlays, overlays, or full crowns due to excessive loss of tooth structure after root canal treatment
• Teeth with structural loss severe enough to require post-core application
• Cases in which adequate anesthesia cannot be achieved with local anesthesia alone (requiring additional intrapulpal or intraligamentary anesthesia)
• Teeth requiring active periodontal treatment
• Individuals with severe systemic diseases

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Keçiören, 06490, Turkey (Türkiye)

Location

Related Publications (5)

• Hegde VR, Hegde SR, Fanibunda UE, Vartak MA. Comparative evaluation of postoperative pain and healing following root canal obturation with calcium silicate and bioactive glass-based sealers to epoxy resin-based sealers: A systematic review and meta-analysis. J Conserv Dent Endod. 2025 Mar;28(3):211-221. doi: 10.4103/JCDE.JCDE_8_25. Epub 2025 Mar 3.

  PMID: 40256693 BACKGROUND

• Gotler M, Bar-Gil B, Ashkenazi M. Postoperative pain after root canal treatment: a prospective cohort study. Int J Dent. 2012;2012:310467. doi: 10.1155/2012/310467. Epub 2012 Mar 15.

  PMID: 22505897 BACKGROUND

• de Oliveira CB, Rocha TG, Pintor AVB, Magno MB, Abrahao AC, Maia LC, Romanach MJ, Visconti MA. Using fractal analysis to assess periapical bone formation after endodontic treatment: A systematic review and meta-analysis. Imaging Sci Dent. 2025 Jun;55(2):126-138. doi: 10.5624/isd.20240221. Epub 2025 Apr 10.

  PMID: 40607066 BACKGROUND

• Cosar M, Kandemir Demirci G, Caliskan MK. The effect of two different root canal sealers on treatment outcome and post-obturation pain in single-visit root canal treatment: A prospective randomized clinical trial. Int Endod J. 2023 Mar;56(3):318-330. doi: 10.1111/iej.13870. Epub 2022 Nov 22.

  PMID: 36385378 BACKGROUND

• Tan HSG, Lim KC, Lui JN, Lai WMC, Yu VSH. Postobturation Pain Associated with Tricalcium Silicate and Resin-based Sealer Techniques: A Randomized Clinical Trial. J Endod. 2021 Feb;47(2):169-177. doi: 10.1016/j.joen.2020.10.013. Epub 2020 Oct 22.

  PMID: 33098889 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

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

• Neslihan Büşra KESKİN KESKİN

  Ankara Yıldırım Beyazıt University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The bioistatician performing the data analysis will be blinded to group allocation. The clinician performing the treatments will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)