Postoperative Pain, AcuteNCT06515756
Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers
A study testing Post operative pain assessment after root canal treatment in people with Postoperative Pain, Acute, run by Kırıkkale University at 2 sites in Turkey (Türkiye).
Trial summary
Brief Summary: The purpose of this study was to evaluate the effect of MTA-Bioseal, GuttaFlow bioseal, and NeoSealer Flo calcium-silicate based root canal sealers on postobturation pain in teeth with asymptomatic irreversible pulpitis or chronic apical periodontitis undergoing single-visit root canal treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Post operative pain assessment after root canal treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Jul 2023to 2 Feb 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral hygiene,
- Not reporting pain before the appointment
- Asymptomatic irreversible pulpitis caused by deep carious lesions (vital cases),
- Asymptomatic primary apical periodontitis (non-vital cases).
Who cannot join
- Pregnancy,
- Autoimmune diseases,
- Uncontrolled diabetes,
- Smokers,
- Advanced periodontal disease (with 5 mm or more probing depth),
- Patients requiring endodontic treatment for more than one tooth,
Show all 11Show fewer
- Unrestorable coronal destruction,
- Incomplete root formation, systemic,
- Allergic sensitivity to local anesthetic or NSAIDs.
- ASA II patient
- An analgesic or antibiotic intake the 7 days before the beginning of treatment
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ali Turkyilmaz
Kirikkale, 71400
Ali Turkyilmaz
Yahşihan, Kırıkkale, 71400
About this study
Official title: The Effect of Three Different Bioceramic-Based Root Canal Sealers on Post-Operative Pain
Brief Summary: The purpose of this study was to evaluate the effect of MTA-Bioseal, GuttaFlow bioseal, and NeoSealer Flo calcium-silicate based root canal sealers on postobturation pain in teeth with asymptomatic irreversible pulpitis or chronic apical periodontitis undergoing single-visit root canal treatment.
The study tried to answer whether the type of sealer used altered the incidence and intensity of postobturation endodontic pain, whether pulp status affected the incidence and intensity of postobturation endodontic pain and whether there was no difference in analgesic intake by patients after a single-visit root canal treatment between the experimental groups.
Read the detailed description
This prospective clinical study was reported pain levels experienced after obturation were similar for the different pulp statuses and root canal sealers tested. The participants with single-rooted teeth were included and divided into four groups according to the root canal sealer used. Then, the patients were divided into two subgroups according to pulp vitality. The postobturation pain scores were recorded after obturation on a visual analog scale (VAS) at 6, 12, 24, and 48 hours, and at 7 and 30 days. The level of pain experienced after obturation was similar for all root canal sealers in different pulp statuses. The results of the study showed that the bioceramic-based sealers tested can be used safely in clinical practice in terms of postobturation pain.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Post operative pain assessment after root canal treatment
- Keywords
- Calcium-silicate,, Pain, Postobturation, Root canal sealer, Visual analog scale
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post operative pain assessment after root canal treatmentOther
the sealer was administered to the root canal using the initial paper point and then uniformly distributed using a second paper point before removing any excess sealer with a third paper point. Once the sealer was applied, a single tapered gutta-percha cone was adjusted to fit the root canal. The coronal access cavities were restored with a composite resin material
| Study group | Role | What they receive |
|---|---|---|
| All participates were divided into four experimantal groups according to the root canal sealers | Experimental | Participates were divided into four experimantal groups. Receives: Other: Post operative pain assessment after root canal treatment |
| Groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis | Experimental | Four different root canal sealer groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis. Although sealers were different, they was applied with the same technique. Receives: Other: Post operative pain assessment after root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain from 6 th hours to 30 days between root canal sealers
All participants were asked to rate their perceived pain on the scale, with 0 indicating no pain and 10 indicating the highest possible pain. Pain levels were classified as none, mild (1 to 3), moderate (4 to 7), or severe (8 to 10).
Measured: 6, 24, and 72 hours and at 7 and 30 days
Secondary outcomes (1)
Change in pain from 6 th hours to 30 days between diffrernt pulp status
All participants were asked to rate their perceived pain on the scale, with 0 indicating no pain and 10 indicating the highest possible pain. Pain levels were classified as none, mild (1 to 3), moderate (4 to 7), or severe (8 to 10).
Measured: 6, 24, and 72 hours and at 7 and 30 days,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start4 Jul 2023
- Primary completion23 Nov 2023
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Turkyilmaz, Kırıkkale University
- Investigators
- Ali Turkyilmaz, PhD, Study director, Kirikkale University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515756
- Sponsor's protocol ID
- 01.06.2023-07/06
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors of the article could not reach a consensus on this issue.
Publications
Turkyilmaz A, Baris SD, Hancerliogullari D, Erdemir A. Postobturation Pain of three Novel Calcium Silicate-based sealers with asymptomatic irreversible pulpitis or necrotic pulp with chronic apical periodontitis: prospective clinical trial. BMC Oral Health. 2024 Nov 10;24(1):1366. doi: 10.1186/s12903-024-05161-1.
PubMed 39523312
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Bioceramic-Based Root Canal Sealers on Post-Operative Pain
- ClinicalTrials.gov ID
- NCT06515756
- Acronym / sponsor ID
- 01.06.2023-07/06
- Conditions
- Postoperative Pain, Acute
- Keywords
- Calcium-silicate,, Pain, Postobturation, Root canal sealer, Visual analog scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 23 Jul 2024 (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.
Brief Summary: The purpose of this study was to evaluate the effect of MTA-Bioseal, GuttaFlow bioseal, and NeoSealer Flo calcium-silicate based root canal sealers on postobturation pain in teeth with asymptomatic irreversible pulpitis or chronic apical periodontitis undergoing single-visit root canal treatment.
The study tried to answer whether the type of sealer used altered the incidence and intensity of postobturation endodontic pain, whether pulp status affected the incidence and intensity of postobturation endodontic pain and whether there was no difference in analgesic intake by patients after a single-visit root canal treatment between the experimental groups.
Detailed description
This prospective clinical study was reported pain levels experienced after obturation were similar for the different pulp statuses and root canal sealers tested. The participants with single-rooted teeth were included and divided into four groups according to the root canal sealer used. Then, the patients were divided into two subgroups according to pulp vitality. The postobturation pain scores were recorded after obturation on a visual analog scale (VAS) at 6, 12, 24, and 48 hours, and at 7 and 30 days. The level of pain experienced after obturation was similar for all root canal sealers in different pulp statuses. The results of the study showed that the bioceramic-based sealers tested can be used safely in clinical practice in terms of postobturation pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All participates were divided into four experimantal groups according to the root canal sealers | Experimental | Other: Post operative pain assessment after root canal treatmentParticipates were divided into four experimantal groups. |
| Groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis | Experimental | Other: Post operative pain assessment after root canal treatmentFour different root canal sealer groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis. Although sealers were different, they was applied with the same technique. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good oral hygiene,
- Not reporting pain before the appointment
- Asymptomatic irreversible pulpitis caused by deep carious lesions (vital cases),
- Asymptomatic primary apical periodontitis (non-vital cases).
Key exclusion criteria (11 listed)
- Pregnancy,
- Autoimmune diseases,
- Uncontrolled diabetes,
- Smokers,
- Advanced periodontal disease (with 5 mm or more probing depth),
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 |
|---|---|---|
| Post operative pain assessment after root canal treatmentthe sealer was administered to the root canal using the initial paper point and then uniformly distributed using a second paper point before removing any excess sealer with a third paper point. Once the sealer was applied, a single tapered gutta-percha cone was adjusted to fit the root canal. The coronal access cavities were restored with a composite resin material | Other | All participates were divided into four experimantal groups according to the root canal sealers, Groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis |
Primary outcome
Change in pain from 6 th hours to 30 days between root canal sealers
Time frame: 6, 24, and 72 hours and at 7 and 30 days
All participants were asked to rate their perceived pain on the scale, with 0 indicating no pain and 10 indicating the highest possible pain. Pain levels were classified as none, mild (1 to 3), moderate (4 to 7), or severe (8 to 10).
1 secondary outcome
Change in pain from 6 th hours to 30 days between diffrernt pulp status
Time frame: 6, 24, and 72 hours and at 7 and 30 days,
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 1 Aug 2024.
- Derived from this study: PubMed 39523312Turkyilmaz A, Baris SD, Hancerliogullari D, Erdemir A. Postobturation Pain of three Novel Calcium Silicate-based sealers with asymptomatic irreversible pulpitis or necrotic pulp with chronic apical periodontitis: prospective clinical trial. BMC Oral Health. 2024 Nov 10;24(1):1366. doi: 10.1186/s12903-024-05161-1.
- Individual participant dataSharing planned: No. The authors of the article could not reach a consensus on this issue.
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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.
Ali Turkyilmaz, PhD study director
Kirikkale University, Faculty of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post operative pain assessment after root canal treatment in people with Postoperative Pain, Acute, run by Kırıkkale University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 11 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 in pain from 6 th hours to 30 days between root canal sealers (time frame: 6, 24, and 72 hours and at 7 and 30 days). 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 NCT06515756, which also lists 1 linked publication.
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 1 Aug 2024.