The Effect of Two Different Root Canal Sealers on Postobturation Pain and Clinical and Radiographical Outcome After Two-year Follow-up

NCT05266599 | Completed DMC

• 1 other identifier: 19-11/6
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Post-obturation pain evaluation(Part 1): One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal preparations in both groups. Root canals were obturated with the manufacturer advised own gutta-percha points of preparation technique and MTA Fillapex was used in the first group and AH Plus was used in the second group as a root canal sealer. Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal treatment was measured with the Numerical Rating Scale (NRS), and patients were informed to record the number of analgesics they used during these time periods. Clinical and radiological outcome evaluation(Part 2): Patients were recalled for clinical and radiographic examinations at 12 and 24 months postoperatively. The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination at follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria. Teeth with a normal contour, width, and structure of the periodontal ligament were considered as"successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered as "failed". Additionally, the other parameters (age, gender, tooth number, apical gutta level) on treatment success were examined.

Conditions

Asymptomatic Vital Mandibular Molar Teeth

Keywords

asymptomatic irreversible pulpitis; bioceramic sealer; post-obturation pain; resin-based sealer; treatment outcome

Outcome Measures

Primary Outcomes (1)

• The incidence and intensity of post-obturation pain

  Post-obturation pain up to 30 days after root canal treatment was measured with Numerical Rating Scale. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.

  up to 30-day

Secondary Outcomes (1)

• Clinical and radiographical success with resin-based and MTA-based bioceramic sealer

  1 year and 2 year follow-up

Study Arms (2)

MTA Fillapex group

ACTIVE COMPARATOR

Root canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. MTA Fillapex sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals.

Other: MTA Fillapex root canal sealer

AH Plus group

ACTIVE COMPARATOR

Root canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. AH Plus sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals.

Other: AH Plus root canal sealer

Interventions

MTA Fillapex root canal sealer OTHER

Root canal treatments were performed with MTA Fillapex

MTA Fillapex group

AH Plus root canal sealer OTHER

Root canal treatments were performed with AH plus

AH Plus group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years
• Good oral hygiene
• Patients with mature mandibular first or second molars diagnosed with asymptomatic irreversible pulpitis due to deep caries
• Teeth that have not been treated endodontically and restoratively before
• A delayed positive response to cold test and electric pulp tests in the vitality test of the teeth
• Large pulpal perforation during caries removal
• Presence of thick and profuse pulpal bleeding could not be controlled within 5 minutes
• Absence of periapical pathology of teeth when confirmed with periapical radiographically

You may not qualify if:

• Patients who refused to participate in the study
• The patients are not systemically healthy, allergic to the materials and agents used during root canal treatment
• Having a history of sensitivity to local anesthetics.
• Patients who used antibiotics and analgesics in the 7 days prior to the beginning of treatment.
• Symptomatic or non-vital teeth
• Patients have more than one tooth requiring endodontic treatment
• Teeth with material loss that cannot be restored, or teeth that require a post or that will be used as a supporting tooth for a prosthesis
• The presence of advanced periodontal disease (probing depth \>3 mm)
• Presence of calcified root canal, presence of internal or external root resorption
• Second molars with C-shaped root canal anatomy

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Gözde Kandemir Demirci

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (6)

• Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.

  PMID: 32183124 BACKGROUND

• Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.

  PMID: 30397735 RESULT

• Aslan T, Donmez Ozkan H. The effect of two calcium silicate-based and one epoxy resin-based root canal sealer on postoperative pain: a randomized controlled trial. Int Endod J. 2021 Feb;54(2):190-197. doi: 10.1111/iej.13411. Epub 2020 Oct 17.

  PMID: 32929721 RESULT

• Fonseca B, Coelho MS, Bueno CEDS, Fontana CE, Martin AS, Rocha DGP. Assessment of Extrusion and Postoperative Pain of a Bioceramic and Resin-Based Root Canal Sealer. Eur J Dent. 2019 Jul;13(3):343-348. doi: 10.1055/s-0039-3399457. Epub 2019 Dec 3.

  PMID: 31794999 RESULT

• Chybowski EA, Glickman GN, Patel Y, Fleury A, Solomon E, He J. Clinical Outcome of Non-Surgical Root Canal Treatment Using a Single-cone Technique with Endosequence Bioceramic Sealer: A Retrospective Analysis. J Endod. 2018 Jun;44(6):941-945. doi: 10.1016/j.joen.2018.02.019. Epub 2018 Mar 29.

  PMID: 29606401 RESULT

• Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.

  PMID: 29061359 RESULT

MeSH Terms

Interventions

epoxy resin-based root canal sealer

Study Officials

• Gözde K Demirci, Dr

  Ege University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Melis Coşar

  Ege University Faculty of Dentistry

  STUDY CHAIR

• Mehmet Kemal Çalışkan, Prof.Dr

  Ege University Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 4, 2022
• Study Start: November 20, 2019
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)