Effect of Material and TechniqueNCT06075550
Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers With Obturation Techniques
A study testing single cone technique using TotalFill BC Sealer and warm vertical compaction technique using TotalFill BC Sealer HiFlow in people with Effect of Material and Technique, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Material and Technique
- What is being tested?
- single cone technique using TotalFill BC Sealer and warm vertical compaction technique using TotalFill BC Sealer HiFlow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2021to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers After Different Obturation Techniques: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Effect of Material and Technique
- Being tested
- single cone technique using TotalFill BC Sealer, warm vertical compaction technique using TotalFill BC Sealer HiFlow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single cone technique using TotalFill BC SealerOther
Gutta percha cone size X5 (Dentsply, Maillefer) TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)
warm vertical compaction technique using TotalFill BC Sealer HiFlowOther
TotalFill BC Sealer HiFlow (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)
| Study group | Role | What they receive |
|---|---|---|
| TotalFill BC Sealer | Experimental | single cone technique with TotalFill BC Sealer Receives: Other: single cone technique using TotalFill BC Sealer; Other: warm vertical compaction technique using TotalFill BC Sealer HiFlow |
| TotalFill BC Sealer HiFlow | Experimental | warm vertical compaction technique with TotalFill BC Sealer HiFlow Receives: Other: single cone technique using TotalFill BC Sealer; Other: warm vertical compaction technique using TotalFill BC Sealer HiFlow |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of postoperative pain (Visual Analog Scale )
numerical (0-10)
Measured: postoperative pain at 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start2 Jun 2021
- Primary completion16 Sep 2021
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Effect of Material and TechniqueStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Amr Youssef Shoukry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075550
- Sponsor's protocol ID
- 439
- Status last verified
- Oct 2023
- First submitted
- 21 Apr 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 21419285Sathorn 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.
PubMed 17956561El 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.
PubMed 20003932
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers After Different Obturation Techniques: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06075550
- Acronym / sponsor ID
- 439
- Conditions
- Effect of Material and Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TotalFill BC Sealer | Experimental | Other: single cone technique using TotalFill BC Sealer, Other: warm vertical compaction technique using TotalFill BC Sealer HiFlowsingle cone technique with TotalFill BC Sealer |
| TotalFill BC Sealer HiFlow | Experimental | Other: single cone technique using TotalFill BC Sealer, Other: warm vertical compaction technique using TotalFill BC Sealer HiFlowwarm vertical compaction technique with TotalFill BC Sealer HiFlow |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single cone technique using TotalFill BC SealerGutta percha cone size X5 (Dentsply, Maillefer) TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) | Other | TotalFill BC Sealer, TotalFill BC Sealer HiFlow |
| warm vertical compaction technique using TotalFill BC Sealer HiFlowTotalFill BC Sealer HiFlow (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) | Other | TotalFill BC Sealer, TotalFill BC Sealer HiFlow |
Primary outcome
change of postoperative pain (Visual Analog Scale )
Time frame: postoperative pain at 6 hours
numerical (0-10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Results publication: PubMed 21419285Pak 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 publication: PubMed 17956561Sathorn 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 publication: PubMed 20003932El 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single cone technique using TotalFill BC Sealer and warm vertical compaction technique using TotalFill BC Sealer HiFlow in people with Effect of Material and Technique, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of postoperative pain (Visual Analog Scale ) (time frame: postoperative pain at 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06075550, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.