Bioceramics Pain Control

Not Applicable

Completed

• Conditions: Post Operative Pain; Endodontically Treated Teeth
• Interventions: Procedure: obturation

• Registration Number: NCT05399303
• Lead Sponsor: Misr International University

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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-03-15
• Study Completion: 2022-05-03
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Status Verified: 2022-06
• Study First Posted: 2022-06-01
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bioceramic sealer obturation	obturation	-
resin sealer	obturation	-

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	one week	Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Trial Locations

Locations (1)

MIU; 🇪🇬 Cairo, Egypt