Bioceramics Pain Control

NCT05399303 | Completed

• 1 other identifier: END 10 231
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain in endodontic retreatment cases presents a challenge to any endodontist. Tricalcium silicate materials as mineral trioxide aggregate (MTA) and bioceramics have shown favorable periapical tissue reactions and healing when used as part of the root canal filling material. This study was conducted to compare the difference in the postoperative pain when resin cements are used versus bioceramic cements in the obturation of root canals.

Conditions

Endodontically Treated Teeth; Post Operative Pain

Keywords

bio-ceramic postoperative pain sealer

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS)

  Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  one week

Study Arms (2)

bioceramic sealer obturation

EXPERIMENTAL

Procedure: obturation

resin sealer

EXPERIMENTAL

Procedure: obturation

Interventions

obturation PROCEDURE

obturation using different types of sealers

bioceramic sealer obturation; resin sealer

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mandibular molars with fully formed roots that need retreatment.
• Age range 20 - 50 years.
• Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root.

You may not qualify if:

• Patients with separated files that need to be retrieved or bypassed.
• Pregnant females.
• Patients suffering from a systemic disease.
• Teeth with lesions connected to adjacent teeth.
• Teeth with root fractures or perforations.
• Teeth with lesions communicating with the alveolar crest.
• Patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
• Teeth with damaged or resorbed peri- apex
• Teeth that were treated with a fiber post and teeth with canal curvature more than 30 degrees.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

MIU

Cairo, 11341, Egypt

Location

Related Publications (11)

• Yoldas O, Topuz A, Isci AS, Oztunc H. Postoperative pain after endodontic retreatment: single- versus two-visit treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Oct;98(4):483-7. doi: 10.1016/j.tripleo.2004.03.009.

  PMID: 15472665 BACKGROUND

• Comparin D, Moreira EJL, Souza EM, De-Deus G, Arias A, Silva EJNL. Postoperative Pain after Endodontic Retreatment Using Rotary or Reciprocating Instruments: A Randomized Clinical Trial. J Endod. 2017 Jul;43(7):1084-1088. doi: 10.1016/j.joen.2017.02.010. Epub 2017 May 3.

  PMID: 28477995 BACKGROUND

• Seltzer S, Naidorf IJ. Flare-ups in endodontics: I. Etiological factors. 1985. J Endod. 2004 Jul;30(7):476-81; discussion 475. doi: 10.1097/00004770-200407000-00005.

  PMID: 15220641 BACKGROUND

• Trope M. Flare-up rate of single-visit endodontics. Int Endod J. 1991 Jan;24(1):24-6. doi: 10.1111/j.1365-2591.1991.tb00866.x.

  PMID: 1917085 BACKGROUND

• Mattscheck DJ, Law AS, Noblett WC. Retreatment versus initial root canal treatment: factors affecting posttreatment pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Sep;92(3):321-4. doi: 10.1067/moe.2001.115135.

  PMID: 11552152 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 BACKGROUND

• 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 BACKGROUND

• Drumond JPSC, Maeda W, Nascimento WM, Campos DL, Prado MC, de-Jesus-Soares A, Frozoni M. Comparison of Postobturation Pain Experience after Apical Extrusion of Calcium Silicate- and Resin-Based Root Canal Sealers. J Endod. 2021 Aug;47(8):1278-1284. doi: 10.1016/j.joen.2021.05.008. Epub 2021 May 29.

  PMID: 34058249 BACKGROUND

• Materials used for root canal obturation: technical, biological and clinical testingORSTAVIK DEndodontic Topics (2005) 12(1)

  BACKGROUND

• DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.

  PMID: 12075212 BACKGROUND

• Toia CC, Khoury RD, Corazza BJM, Orozco EIF, Valera MC. Effectiveness of 1-Visit and 2-Visit Endodontic Retreatment of Teeth with Persistent/Secondary Endodontic Infection: A Randomized Clinical Trial with 18 Months of Follow-up. J Endod. 2022 Jan;48(1):4-14. doi: 10.1016/j.joen.2021.09.004. Epub 2021 Sep 20.

  PMID: 34555421 BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital; Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: January 1, 2022
• Primary Completion: March 15, 2022
• Study Completion: May 3, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)