Bioceramics Pain Control
Primary Purpose
Endodontically Treated Teeth, Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
obturation
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring bio-ceramic postoperative pain sealer
Eligibility Criteria
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.
Sites / Locations
- MIU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
bioceramic sealer obturation
resin sealer
Arm Description
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
Full Information
NCT ID
NCT05399303
First Posted
May 26, 2022
Last Updated
June 1, 2022
Sponsor
Misr International University
1. Study Identification
Unique Protocol Identification Number
NCT05399303
Brief Title
Bioceramics Pain Control
Official Title
Pain Evaluation After Single Visit Nonsurgical Retreatment Using a Bio Ceramic Sealer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Misr International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth, Post Operative Pain
Keywords
bio-ceramic postoperative pain sealer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bioceramic sealer obturation
Arm Type
Experimental
Arm Title
resin sealer
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
obturation
Intervention Description
obturation using different types of sealers
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
MIU
City
Cairo
ZIP/Postal Code
11341
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data other than personal data will be shared
Citations:
PubMed Identifier
15472665
Citation
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.
Results Reference
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PubMed Identifier
28477995
Citation
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.
Results Reference
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PubMed Identifier
15220641
Citation
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.
Results Reference
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PubMed Identifier
1917085
Citation
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.
Results Reference
background
PubMed Identifier
11552152
Citation
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.
Results Reference
background
PubMed Identifier
30397735
Citation
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.
Results Reference
background
PubMed Identifier
29571915
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
background
Citation
Materials used for root canal obturation: technical, biological and clinical testingORSTAVIK DEndodontic Topics (2005) 12(1)
Results Reference
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PubMed Identifier
12075212
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. doi: 10.1067/moe.2002.121900.
Results Reference
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PubMed Identifier
34555421
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.
Results Reference
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Bioceramics Pain Control
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