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Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers With Obturation Techniques

Primary Purpose

Effect of Material and Technique

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
single cone technique using TotalFill BC Sealer
warm vertical compaction technique using TotalFill BC Sealer HiFlow
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effect of Material and Technique

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Medically free patients Patients age between 20-50 years Vital pulp as indicated by thermal or electric pulp test No history of previously initiated root canal treatment among the treated tooth Sufficient tooth structure for isolation Teeth with mature apices Exclusion Criteria: Pregnancy or lactation Medically compromised patients Previous endodontic therapy of the tooth to be treated. Teeth diagnosed with non-vital pulp. Periodontally compromised teeth (teeth with periodontal probing depth more than 3mm). Teeth with abnormal anatomy or calcified canals. Teeth with caries below the bony level (non-restorable tooth). Immature teeth with open apices. Complications during treatment (file separation, ledges, perforation, etc.) Overfilling (overextended beyond the radiographic apex) or short filling (more than 2mm of the radiographic apex) Radiographic evidence of root resorption Patients who could not follow the instructions to record the visual analog scale

Sites / Locations

  • Faculty of Oral and dental medicine, Minia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TotalFill BC Sealer

TotalFill BC Sealer HiFlow

Arm Description

single cone technique with TotalFill BC Sealer

warm vertical compaction technique with TotalFill BC Sealer HiFlow

Outcomes

Primary Outcome Measures

change of postoperative pain (Visual Analog Scale )
numerical (0-10)

Secondary Outcome Measures

Full Information

First Posted
April 21, 2023
Last Updated
October 4, 2023
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT06075550
Brief Title
Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers With Obturation Techniques
Official Title
Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers After Different Obturation Techniques: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
September 16, 2021 (Actual)
Study Completion Date
March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
60 patients were divided into 2 groups, 30 patient in each group Group I: Obturation with TotalFill BC Sealer using the single cone technique Group II: Obturation with TotalFill BC Sealer HiFlow using the warm vertical compaction technique. Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.
Detailed Description
Endodontic treatment will be performed in a single visit Root canal preparation After anesthesia a rubber dam will be placed then disinfection of the working field will be done using sodium hypochlorite swab. All caries will be removed then an endodontic access cavity will be established using high speed carbide burs under coolant. Cleaning and shaping of the canal will be performed using rotary ProTaper Next files (Dentsply, Maillefer) connected to an endodontic motor according to the manufacturer's instructions and recommendations. Irrigation with sodium hypochlorite will be always performed during instrumentation. After instrumentation a final flush with sodium hypochlorite followed by distilled water will be performed and the canals will be dried using sterile paper points. Master cone radiograph will be taken for confirmation and obturation will be done according to the mentioned groups. Root canal obturation This study will be a double blind randomized study. Group I: Using TotalFill BC Sealer, the tip of the syringe will be inserted into the canal and the sealer will be dispensed into the root canal as recommended by the manufacturer. A ProTaper Next gutta percha cone (Dentsply, Maillefer) of the same size of the prepared canal will be used for single cone obturation technique and the excess gutta percha will be removed by a heated condenser. Group II: TotalFill BC Sealer HiFlow will be inserted into the canal as in Group I and the master gutta percha cone will be placed and warm vertical compaction technique will be done. The depth of the heated plugger will be 5 mm less than the WL followed by back filling. After obturation, the access cavity will be cleaned and a sterile cotton pellet is placed and the cavity will be sealed with temporary filling. A postoperative radiograph will be taken Assessment of postoperative pain Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Material and Technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TotalFill BC Sealer
Arm Type
Experimental
Arm Description
single cone technique with TotalFill BC Sealer
Arm Title
TotalFill BC Sealer HiFlow
Arm Type
Experimental
Arm Description
warm vertical compaction technique with TotalFill BC Sealer HiFlow
Intervention Type
Other
Intervention Name(s)
single cone technique using TotalFill BC Sealer
Intervention Description
Gutta percha cone size X5 (Dentsply, Maillefer) TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)
Intervention Type
Other
Intervention Name(s)
warm vertical compaction technique using TotalFill BC Sealer HiFlow
Intervention Description
TotalFill BC Sealer HiFlow (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)
Primary Outcome Measure Information:
Title
change of postoperative pain (Visual Analog Scale )
Description
numerical (0-10)
Time Frame
postoperative pain at 6 hours

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: Medically free patients Patients age between 20-50 years Vital pulp as indicated by thermal or electric pulp test No history of previously initiated root canal treatment among the treated tooth Sufficient tooth structure for isolation Teeth with mature apices Exclusion Criteria: Pregnancy or lactation Medically compromised patients Previous endodontic therapy of the tooth to be treated. Teeth diagnosed with non-vital pulp. Periodontally compromised teeth (teeth with periodontal probing depth more than 3mm). Teeth with abnormal anatomy or calcified canals. Teeth with caries below the bony level (non-restorable tooth). Immature teeth with open apices. Complications during treatment (file separation, ledges, perforation, etc.) Overfilling (overextended beyond the radiographic apex) or short filling (more than 2mm of the radiographic apex) Radiographic evidence of root resorption Patients who could not follow the instructions to record the visual analog scale
Facility Information:
Facility Name
Faculty of Oral and dental medicine, Minia University
City
Minya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
21419285
Citation
Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
Results Reference
result
PubMed Identifier
17956561
Citation
Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
Results Reference
result
PubMed Identifier
20003932
Citation
El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003.
Results Reference
result

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Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers With Obturation Techniques

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