Influence of Sonic Activation of Root Sealers on Post-Operative Pain

NCT06403293 | Completed

• 1 other identifier: 280424
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: This clinical study aims to compare post-operative pain after single-visit root canal treatment of teeth with asymptomatic apical periodontitis using epoxy-resin based AH Plus and calcium silicate based Endosequence BC sealers with or without sonic activation. Materials and Methods: The study included 72 individuals having one first or second mandibular premolar tooth with asymptomatic apical periodontitis. They were randomly divided into 4 groups according to the root canal sealer (AH Plus or Endosequence BC) and activation protocol (sonic activation or non-activation) (n=18). Participants were ask to rate their post-operative pain intensity on a NRS scale as none, minimal, moderate, or severe after 24 h, 48 h, 72 h and 7 days following treatment. Patients were also asked to record the number of prescribed analgesic medication tablets (ibuprofen 400 mg) taken. The collected data were statistically analyzed at 0.05 significance level.

Conditions

Post Operative Pain; Apical Periodontitis

Keywords

apical periodontitis; post operative pain; calcium silicate; endoactivator

Outcome Measures

Primary Outcomes (1)

• post operative pain

  All participants were given a questionnaire based on a 0-10 numeric rating scale (NRS), with 0 indicating no pain and 10 indicating the worst pain. Patients recorded their pain on days 1, 2, 3 and 7 after treatment. Pain intensity was rated into 4 categories using the NRS. None: (NRS 0); Mild (NRS 1-3); Moderate (NRS 4-7); Severe (NRS 8-10).

  1 week

Study Arms (4)

AH Plus-NA

EXPERIMENTAL

AH Plus was mixed according to the manufacturer's instructions. The R40 gutta-percha (VDW) was coated with the sealer and inserted into the canal, and the root canals were filled using the single cone technique (SCT). The sealer was not activated.

Procedure: Root canal treatment (AH Plus-NA)

AH Plus- EA

EXPERIMENTAL

An EA 25/04 tip was coated with AH Plus and activated in the root canals for 10 seconds. Then, the R40 gutta-percha was coated with the sealer and inserted into the canal, and the root canals were filled using SCT.

Procedure: Root canal treatment (AH Plus-EA)

BC-NA

EXPERIMENTAL

The ready-to-use EndoSequence BC was injected into the root canals and no activation was performed. Then, the R40 gutta-percha was inserted into the canali and the root canals were filled using SCT.

Procedure: Root canal treatment (BC-NA)

BC-EA

EXPERIMENTAL

EndoSequence BC was injected into the root canals. An EA 25/04 tip was inserted 2 mm beyond the WL and activated for 10 s. Then, the R40 gutta-percha was inserted into the canal and the root canals were filled using SCT.

Procedure: Root canal treatment (BC-EA)

Interventions

Root canal treatment (AH Plus-NA) PROCEDURE

Root canal treatment procedures explained in arm descriptions.

AH Plus-NA

Root canal treatment (AH Plus-EA) PROCEDURE

Root canal treatment procedures explained in arm descriptions.

AH Plus- EA

Root canal treatment (BC-NA) PROCEDURE

Root canal treatment procedures explained in arm descriptions.

BC-NA

Root canal treatment (BC-EA) PROCEDURE

Root canal treatment procedures explained in arm descriptions.

BC-EA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mandibular first and second premolar teeth diagnosed with asymptomatic apical periodontitis
• Single rooted teeth with a single canal.

You may not qualify if:

• Previous root canal treatment
• Use of any analgesic or antibiotics in the last 7 days
• Symptomatic teeth
• Sinus tract
• Presence of advanced periodontal problem (probing depth \>4 mm)
• Complications during treatment such as broken file, ledging
• Teeth with extensive coronal destruction.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Mustafa Kemal University

Hatay, Antakya, 31000, Turkey (Türkiye)

Location

Related Publications (7)

• 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

• Gundogar M, Sezgin GP, Kaplan SS, Ozyurek H, Uslu G, Ozyurek T. Postoperative pain after different irrigation activation techniques: a randomized, clinical trial. Odontology. 2021 Apr;109(2):385-392. doi: 10.1007/s10266-020-00553-5. Epub 2020 Sep 11.

  PMID: 32915346 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

• Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.

  PMID: 29571915 RESULT

• Wiesse PEB, Silva-Sousa YT, Pereira RD, Estrela C, Domingues LM, Pecora JD, Sousa-Neto MD. Effect of ultrasonic and sonic activation of root canal sealers on the push-out bond strength and interfacial adaptation to root canal dentine. Int Endod J. 2018 Jan;51(1):102-111. doi: 10.1111/iej.12794. Epub 2017 Jun 19.

  PMID: 28543092 RESULT

• Lopes FC, Zangirolami C, Mazzi-Chaves JF, Silva-Sousa AC, Crozeta BM, Silva-Sousa YTC, Sousa-Neto MD. Effect of sonic and ultrasonic activation on physicochemical properties of root canal sealers. J Appl Oral Sci. 2019 Sep 9;27:e20180556. doi: 10.1590/1678-7757-2018-0556.

  PMID: 31508791 RESULT

• Yilmaz K, Sari M. Influence of sonic activation of epoxy-resin and calcium silicate sealer on postoperative pain: a patient-blinded, parallel group, randomized clinical trial. BMC Oral Health. 2024 Oct 23;24(1):1268. doi: 10.1186/s12903-024-05049-0.

  PMID: 39443924 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients were blinded to the chosen root canal sealer and activation protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: January 16, 2023
• Primary Completion: November 21, 2023
• Study Completion: November 28, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)