Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth

NCT07868315 | Recruiting

• 1 other identifier: E-10840098-202.3.02-3256
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the postoperative pain and long-term clinical and radiographic success of single-visit primary root canal treatment in asymptomatic teeth with periapical lesions.

Conditions

Single-visit; Periapical Periodontitis

Keywords

treatment outcome; periapical health; post operative pain; periapical index; Chronic apical periodontitis

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain

  Postoperative pain following single-session primary root canal treatment, assessed using a 10-point visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. higher scores indicate greater pain intensity.

  6 hours, 24 hours, 48 hours, 72 hours, 1 week, 1 month after root canal treatment.

• Clinical Success and Radiographic Radiographic Changes in Periapical Lesion Size Following Root Canal Treatment

  Radiographic assessment of periapical lesion size following single-session primary root canal treatment. Periapical lesion size will be measured on digital periapical radiographs using image analysis software. A coin of known diameter will be used as a radiographic calibration reference to standardize measurements. The maximum diameter of the periapical radiolucency will be measured in millimeters (mm) at each follow-up examination (1, 3, 6, and 12 months). Changes in lesion size will be calculated by comparing measurements obtained at baseline and subsequent follow-up examinations.

  1 months / 3 months /6 months / 12 months

Study Arms (4)

One Fill

EXPERIMENTAL

Root canal obturation using One Fill root canal sealer according to the manufacturer's instructions.

Other: One-Fill

TotalFill

EXPERIMENTAL

Root canal obturation using TotalFill root canal sealer according to the manufacturer's instructions.

Other: TotalFill

AH Plus + Single Cone

EXPERIMENTAL

Root canal obturation using AH Plus root canal sealer in combination with a single-cone obturation technique.

Other: AH Plus + Single Cone

AH Plus + Continuous Wave

EXPERIMENTAL

Root canal obturation using AH Plus root canal sealer in combination with a continuous-wave obturation technique.

Other: AH Plus + Continuous Wave

Interventions

One-Fill OTHER

Root canal obturation using One-Fill bioceramic sealer with a single-cone technique. The prepared root canal is filled with a fitted gutta-percha cone coated with One-Fill sealer according to the manufacturer's instructions.

One Fill

TotalFill OTHER

Root canal obturation using TotalFill BC Sealer with a single-cone technique. The prepared root canal is filled with a fitted gutta-percha cone coated with TotalFill BC Sealer according to the manufacturer's instructions.

TotalFill

AH Plus + Single Cone OTHER

Root canal obturation using AH Plus epoxy resin-based sealer with a single-cone technique. A fitted gutta-percha cone is coated with AH Plus sealer and placed to the working length according to the study protocol.

AH Plus + Single Cone

AH Plus + Continuous Wave OTHER

Root canal obturation using AH Plus epoxy resin-based sealer with the continuous wave of condensation technique. The master gutta-percha cone is fitted to the working length, followed by down-pack and backfill procedures using heated gutta-percha according to the study protocol.

AH Plus + Continuous Wave

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-65 years.
• Patients classified as ASA Physical Status I or II according to the American Society of Anesthesiologists (ASA) classification:
• Teeth that have not previously undergone root canal retreatment or surgical intervention.
• Patients who are able to read and sign the informed consent form.
• Patients who are physically and mentally able to tolerate the planned dental treatment.
• Teeth treated in a single treatment session.

You may not qualify if:

• Pregnant or lactating women.
• Patients with chronic periodontal disease and/or a periodontal probing depth \>4 mm.
• Symptomatic patients.
• Patients who are unable to comply with the scheduled follow-up periods.
• Patients who have used analgesics within 1 week or antibiotics within 1 month prior to treatment.
• Teeth with root resorption.
• Teeth with a vertical root fracture or a risk of vertical root fracture.
• Teeth with incomplete root development.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

RECRUITING

Related Publications (12)

• Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.

  PMID: 3457698 RESULT

• Schilder H. Filling root canals in three dimensions. 1967. J Endod. 2006 Apr;32(4):281-90. doi: 10.1016/j.joen.2006.02.007. No abstract available.

  PMID: 16554195 RESULT

• Wu MK, Bud MG, Wesselink PR. The quality of single cone and laterally compacted gutta-percha fillings in small and curved root canals as evidenced by bidirectional radiographs and fluid transport measurements. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):946-51. doi: 10.1016/j.tripleo.2009.07.046. Epub 2009 Oct 28.

  PMID: 19875314 RESULT

• Raman V, Camilleri J. Characterization and Assessment of Physical Properties of 3 Single Syringe Hydraulic Cement-based Sealers. J Endod. 2024 Mar;50(3):381-388. doi: 10.1016/j.joen.2024.01.001. Epub 2024 Jan 14.

  PMID: 38219956 RESULT

• Candeiro GT, Correia FC, Duarte MA, Ribeiro-Siqueira DC, Gavini G. Evaluation of radiopacity, pH, release of calcium ions, and flow of a bioceramic root canal sealer. J Endod. 2012 Jun;38(6):842-5. doi: 10.1016/j.joen.2012.02.029. Epub 2012 Apr 4.

  PMID: 22595123 RESULT

• Guven EP, Tasli PN, Yalvac ME, Sofiev N, Kayahan MB, Sahin F. In vitro comparison of induction capacity and biomineralization ability of mineral trioxide aggregate and a bioceramic root canal sealer. Int Endod J. 2013 Dec;46(12):1173-82. doi: 10.1111/iej.12115. Epub 2013 Apr 26.

  PMID: 23617276 RESULT

• Veljovic D, Colic M, Kojic V, Bogdanovic G, Kojic Z, Banjac A, Palcevskis E, Petrovic R, Janackovic D. The effect of grain size on the biocompatibility, cell-materials interface, and mechanical properties of microwave-sintered bioceramics. J Biomed Mater Res A. 2012 Nov;100(11):3059-70. doi: 10.1002/jbm.a.34225. Epub 2012 Jun 26.

  PMID: 22733649 RESULT

• Jo SB, Kim HK, Lee HN, Kim YJ, Dev Patel K, Campbell Knowles J, Lee JH, Song M. Physical Properties and Biofunctionalities of Bioactive Root Canal Sealers In Vitro. Nanomaterials (Basel). 2020 Sep 4;10(9):1750. doi: 10.3390/nano10091750.

  PMID: 32899641 RESULT

• Camargo RV, Silva-Sousa YTC, Rosa RPFD, Mazzi-Chaves JF, Lopes FC, Steier L, Sousa-Neto MD. Evaluation of the physicochemical properties of silicone- and epoxy resin-based root canal sealers. Braz Oral Res. 2017 Aug 21;31:e72. doi: 10.1590/1807-3107BOR-2017.vol31.0072.

  PMID: 28832718 RESULT

• Sathorn C, Parashos P, Messer HH. Effectiveness of single- versus multiple-visit endodontic treatment of teeth with apical periodontitis: a systematic review and meta-analysis. Int Endod J. 2005 Jun;38(6):347-55. doi: 10.1111/j.1365-2591.2005.00955.x.

  PMID: 15910469 RESULT

• Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.

  PMID: 17931388 RESULT

• Karamifar K, Tondari A, Saghiri MA. Endodontic Periapical Lesion: An Overview on the Etiology, Diagnosis and Current Treatment Modalities. Eur Endod J. 2020 Jul 14;5(2):54-67. doi: 10.14744/eej.2020.42714. eCollection 2020.

  PMID: 32766513 RESULT

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

• Tan Firat eyuboglu, Prof

  STUDY DIRECTOR

Central Study Contacts

omer albanki, DDS

CONTACT

00905365927496; omaralbanki1997@gmail.com

Yelda Erdem Hepsenoglu, PhD

CONTACT

00905054104563; yelda_erdem89@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 9, 2026
• Study Start: April 22, 2025
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After its publication in a journal, the investigators want to share their data.
• Access Criteria: Postoperative pain scores, radiographic and clinical findings.

Locations

TU (1)