Bioceramics Pain Control

Post Operative Pain Clinical Trial

Official title:

Pain Evaluation After Single Visit Nonsurgical Retreatment Using a Bio Ceramic Sealer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399303
• Other study ID #: END 10 231
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 3, 2022

Study information

• Verified date: June 2022
• Source: Misr International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Faculty of Dentistry Ain Shams University's Research Ethics Committee reviewed the current proposal for ethical approval. One hundred patients with permanent molar teeth requiring endodontic non-surgical retreatment were treated in this study. Teeth with fractured instruments were excluded. Patient ages ranged from twenty to fifty years, both men and women were treated in the current study. Infants, children, people unable to take decisions, university students, orphans, mentally or physically disabled patients were excluded from the current study. Preoperative assessment of the degree of the patient's pain was done using the visual analog scale. Fifty teeth were obturated with gutta percha using the epoxy resin-based sealer (AH Plus) as the control group, and in the other fifty bioceramic based cement (Endosequence) was used. All teeth were prepared by the protaper next rotary files (Dentsply Sirona) under copious irrigation with 30ml of 2.6 % sodium hypochlorite throughout the procedure. Ethylamine diamine tetracetic acid (EDTA) 17% was used to remove the smear layer before the obturation commenced. Obturation was done using the cold lateral compaction technique in the resin group and single cone technique in the bioceramic group. Postoperative pain assessment was done for each patient after six hours, twenty-four hours, four days and one week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 3, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Pain, Postoperative
• Post Operative Pain
• Tooth, Nonvital

Intervention

Procedure:
• obturation
obturation using different types of sealers

Locations

Country	Name	City	State
Egypt	MIU	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Misr International University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trialAtav Ates A, Dumani A Clinical Oral Investigations (2019) 23(7)

Seltzer S, Naidorf IJ. Flare-ups in endodontics: I. Etiological factors. 1985. J Endod. 2004 Jul;30(7):476-81; discussion 475. — View Citation

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. — View Citation

Trope M. Flare-up rate of single-visit endodontics. Int Endod J. 1991 Jan;24(1):24-6. — View Citation

Yoldas O, Topuz A, Isçi 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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