Comparison of the Effects of Bio Ceramic and Epoxy Resin-based Sealers on Postoperative Pain After Root Canal Treatment
1 other identifier
interventional
40
1 country
1
Brief Summary
This study aims to compare the effect of bio ceramic sealer and resin-based sealer on the intensity and occurrence of post operative pain in single rooted teeth with asymptomatic apical periodontitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedStudy Start
First participant enrolled
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 25, 2024
November 1, 2024
12 months
July 31, 2024
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post operative pain questionnaire
The participants of the study groups will be given a questionnaire to record whether they experienced pain following the root canal treatment after applying each type of the study sealers or no, during the Time frame.
assessed at 24 hours, 48 hours, and 7 days post-treatment.
Secondary Outcomes (2)
Intensity of postoperative pain
assessed at 24 hours, 48 hours, and 7 days post-treatment.
Analgesic
assessed at 24 hours, 48 hours, and 7 days post-treatment.
Study Arms (2)
Control Group
ACTIVE COMPARATORThe control group will be treated by using Resin based sealer during obturation which will be selected at random.
Intervention
ACTIVE COMPARATORThe comparator group will receive Bioceramic sealer during obturation as intervention which will be selected at random.
Interventions
Root canal sealer will be placed inside the root canals during obturation procedure to seal dentine wall and reinforce the remaining tooth tissue.It will be selected randomly to the study samples.
Root canal sealer will be placed inside the root canals during obturation procedure to seal dentine wall and reinforce the remaining tooth tissue.It will be selected randomly to the study samples.
Eligibility Criteria
You may qualify if:
- Permanent single rooted tooth 1-1 configuration and complete root development.
- Requiring root canal treatment.
- Diagnosed with Asymptomatic apical periodontitis, teeth asymptomatic, periapical index will exhibit an apical radiolucency.
- Willing to Participate.
You may not qualify if:
- Medically compromised patients.
- Inability to reach working length, complication during treatment.
- Retreatment teeth, multi rooted teeth.
- Periodontological compromised teeth.
- Uncooperative patients.
- Pregnant patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Primary Health Corporation
Doha, Qatar
Related Publications (4)
Tan HSG, Lim KC, Lui JN, Lai WMC, Yu VSH. Postobturation Pain Associated with Tricalcium Silicate and Resin-based Sealer Techniques: A Randomized Clinical Trial. J Endod. 2021 Feb;47(2):169-177. doi: 10.1016/j.joen.2020.10.013. Epub 2020 Oct 22.
PMID: 33098889BACKGROUNDZamparini F, Lenzi J, Duncan HF, Spinelli A, Gandolfi MG, Prati C. The efficacy of premixed bioceramic sealers versus standard sealers on root canal treatment outcome, extrusion rate and post-obturation pain: A systematic review and meta-analysis. Int Endod J. 2024 Aug;57(8):1021-1042. doi: 10.1111/iej.14069. Epub 2024 Apr 12.
PMID: 38606520BACKGROUNDKhandelwal A, Jose J, Teja KV, Palanivelu A. Comparative evaluation of postoperative pain and periapical healing after root canal treatment using three different base endodontic sealers - A randomized control clinical trial. J Clin Exp Dent. 2022 Feb 1;14(2):e144-e152. doi: 10.4317/jced.59034. eCollection 2022 Feb.
PMID: 35173897RESULTAslan 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: 32929721RESULT
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Dareen Azzouz
Primary Health care corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Endodontist
Study Record Dates
First Submitted
July 31, 2024
First Posted
August 7, 2024
Study Start
October 28, 2024
Primary Completion
October 27, 2025
Study Completion
December 31, 2025
Last Updated
November 25, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
A password protected computer system is used to assure secure data storage.Only encrypted systems are used for storing research data on laptops. A locked file cabinet is used to store research related paper forms.Access to study data is limited to only a few members of the study team.Plans are set to destroy all research generated data after 3 years according to PHCC regulations.The study report / publication will show only aggregate results with no identifiers. Only deidentified study data is stored. A code number is used instead of the participant's real name on study data and blood/tissue samples.