Post Operative PainNCT06403293
Influence of Sonic Activation of Root Sealers on Post-Operative Pain
A study testing Root canal treatment (AH Plus-NA), Root canal treatment (AH Plus-EA) and Root canal treatment (BC-NA) in people with Post Operative Pain and Apical Periodontitis, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This clinical study aims to compare post-operative pain after single-visit root canal treatment of teeth with asymptomatic apical periodontitis using epoxy-resin based AH Plus and calcium silicate based Endosequence BC sealers with or without sonic activation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Apical Periodontitis
- What is being tested?
- Root canal treatment (AH Plus-NA), Root canal treatment (AH Plus-EA) and Root canal treatment (BC-NA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2023to 28 Nov 2023
- 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
- Mandibular first and second premolar teeth diagnosed with asymptomatic apical periodontitis
- Single rooted teeth with a single canal.
Who cannot join
- Previous root canal treatment
- Use of any analgesic or antibiotics in the last 7 days
- Symptomatic teeth
- Sinus tract
- Presence of advanced periodontal problem (probing depth >4 mm)
- Complications during treatment such as broken file, ledging
- Teeth with extensive coronal destruction.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mustafa Kemal University
Hatay, Antakya, 31000
About this study
Official title: Influence of Sonic Activation of Epoxy Resin and Calcium Silicate Sealer on Post-Operative Pain: A Patient-Blinded, Randomised Clinical Trial
Aim: This clinical study aims to compare post-operative pain after single-visit root canal treatment of teeth with asymptomatic apical periodontitis using epoxy-resin based AH Plus and calcium silicate based Endosequence BC sealers with or without sonic activation.
Materials and Methods: The study included 72 individuals having one first or second mandibular premolar tooth with asymptomatic apical periodontitis. They were randomly divided into 4 groups according to the root canal sealer (AH Plus or Endosequence BC) and activation protocol (sonic activation or non-activation) (n=18). Participants were ask to rate their post-operative pain intensity on a NRS scale as none, minimal, moderate, or severe after 24 h, 48 h, 72 h and 7 days following treatment. Patients were also asked to record the number of prescribed analgesic medication tablets (ibuprofen 400 mg) taken. The collected data were statistically analyzed at 0.05 significance level.
Read the detailed description
Root Canal Treatment After inferior alveolar nervus block anesthesia with 4% Articaine with 1:100,000 adrenaline, the tooth was isolated with a rubber dam. The access cavity was opened using high-speed diamond round burs under water cooling. The working length (WL) was set at 0.5 mm shorter than the 0.0 reading using a 15 K-type file and apex locator (Morita Root ZX, Japan) and checked with radiographs. The root canals were prepared with Resiproc (Resiproc, VDW, Munich, Germany) R25 and R40 files, respectively, at the WL using the crown down technique. A total of 20 mL of 2.5% sodium hypochlorite (NaOCl) was used with a 30-gauge needle (Max-i-Probe; Dentsply Sirona) during preparation. 5 mL of distilled water was left in the canal for 1 min to neutralize the effect of NaOCl, and then the root canals were irrigated with 3 ml of 17% ethylene diamine tetra acetic acid (EDTA). EDTA was activated for 3 × 20s with the EA 25/04 tip 2 mm shorter than the WL. The EA tip was used with 2-4 mm vertical strokes. The root canals were irrigated with 5 mL distilled water and dried with paper points.
The subjects were divided into four groups for root filling. Randomization was performed using online software (www.randomizer.org) with a four-block-sized block randomization technique to ensure even distribution between the groups (allocation ratio 1:1:1:1). A co-investigator managed the allocation and reported the allocated treatment procedure to the operator. The operator could not be blinded due to the different stages of the treatment protocols. The patients were blinded to the chosen root canal sealer and activation protocol.
- Conditions
- Post Operative Pain, Apical Periodontitis
- Being tested
- Root canal treatment (AH Plus-NA), Root canal treatment (AH Plus-EA), Root canal treatment (BC-NA), Root canal treatment (BC-EA)
- Keywords
- apical periodontitis, post operative pain, calcium silicate, endoactivator
- Medical subject headings
- Pain, Postoperative, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment (AH Plus-NA)Procedure or surgery
Root canal treatment procedures explained in arm descriptions.
Root canal treatment (AH Plus-EA)Procedure or surgery
Root canal treatment procedures explained in arm descriptions.
Root canal treatment (BC-NA)Procedure or surgery
Root canal treatment procedures explained in arm descriptions.
Root canal treatment (BC-EA)Procedure or surgery
Root canal treatment procedures explained in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| AH Plus-NA | Experimental | AH Plus was mixed according to the manufacturer's instructions. The R40 gutta-percha (VDW) was coated with the sealer and inserted into the canal, and the root canals were filled using the single cone technique (SCT). The sealer was not activated. Receives: Procedure: Root canal treatment (AH Plus-NA) |
| AH Plus- EA | Experimental | An EA 25/04 tip was coated with AH Plus and activated in the root canals for 10 seconds. Then, the R40 gutta-percha was coated with the sealer and inserted into the canal, and the root canals were filled using SCT. Receives: Procedure: Root canal treatment (AH Plus-EA) |
| BC-NA | Experimental | The ready-to-use EndoSequence BC was injected into the root canals and no activation was performed. Then, the R40 gutta-percha was inserted into the canali and the root canals were filled using SCT. Receives: Procedure: Root canal treatment (BC-NA) |
| BC-EA | Experimental | EndoSequence BC was injected into the root canals. An EA 25/04 tip was inserted 2 mm beyond the WL and activated for 10 s. Then, the R40 gutta-percha was inserted into the canal and the root canals were filled using SCT. Receives: Procedure: Root canal treatment (BC-EA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
All participants were given a questionnaire based on a 0-10 numeric rating scale (NRS), with 0 indicating no pain and 10 indicating the worst pain. Patients recorded their pain on days 1, 2, 3 and 7 after treatment. Pain intensity was rated into 4 categories using the NRS. None: (NRS 0); Mild (NRS 1-3); Moderate (NRS 4-7); Severe (NRS 8-10).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start16 Jan 2023
- Primary completion21 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sari, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403293
- Sponsor's protocol ID
- 280424
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fonseca B, Coelho MS, Bueno CEDS, Fontana CE, Martin AS, Rocha DGP. Assessment of Extrusion and Postoperative Pain of a Bioceramic and Resin-Based Root Canal Sealer. Eur J Dent. 2019 Jul;13(3):343-348. doi: 10.1055/s-0039-3399457. Epub 2019 Dec 3.
PubMed 31794999Gundogar M, Sezgin GP, Kaplan SS, Ozyurek H, Uslu G, Ozyurek T. Postoperative pain after different irrigation activation techniques: a randomized, clinical trial. Odontology. 2021 Apr;109(2):385-392. doi: 10.1007/s10266-020-00553-5. Epub 2020 Sep 11.
PubMed 32915346Aslan 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.
PubMed 32929721Graunaite 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.
PubMed 29571915Wiesse PEB, Silva-Sousa YT, Pereira RD, Estrela C, Domingues LM, Pecora JD, Sousa-Neto MD. Effect of ultrasonic and sonic activation of root canal sealers on the push-out bond strength and interfacial adaptation to root canal dentine. Int Endod J. 2018 Jan;51(1):102-111. doi: 10.1111/iej.12794. Epub 2017 Jun 19.
PubMed 28543092Lopes FC, Zangirolami C, Mazzi-Chaves JF, Silva-Sousa AC, Crozeta BM, Silva-Sousa YTC, Sousa-Neto MD. Effect of sonic and ultrasonic activation on physicochemical properties of root canal sealers. J Appl Oral Sci. 2019 Sep 9;27:e20180556. doi: 10.1590/1678-7757-2018-0556.
PubMed 31508791Yilmaz K, Sari M. Influence of sonic activation of epoxy-resin and calcium silicate sealer on postoperative pain: a patient-blinded, parallel group, randomized clinical trial. BMC Oral Health. 2024 Oct 23;24(1):1268. doi: 10.1186/s12903-024-05049-0.
PubMed 39443924
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sonic Activation of Epoxy Resin and Calcium Silicate Sealer on Post-Operative Pain: A Patient-Blinded, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06403293
- Acronym / sponsor ID
- 280424
- Conditions
- Post Operative Pain, Apical Periodontitis
- Keywords
- apical periodontitis, post operative pain, calcium silicate, endoactivator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 7 May 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.
Aim: This clinical study aims to compare post-operative pain after single-visit root canal treatment of teeth with asymptomatic apical periodontitis using epoxy-resin based AH Plus and calcium silicate based Endosequence BC sealers with or without sonic activation.
Materials and Methods: The study included 72 individuals having one first or second mandibular premolar tooth with asymptomatic apical periodontitis. They were randomly divided into 4 groups according to the root canal sealer (AH Plus or Endosequence BC) and activation protocol (sonic activation or non-activation) (n=18). Participants were ask to rate their post-operative pain intensity on a NRS scale as none, minimal, moderate, or severe after 24 h, 48 h, 72 h and 7 days following treatment. Patients were also asked to record the number of prescribed analgesic medication tablets (ibuprofen 400 mg) taken. The collected data were statistically analyzed at 0.05 significance level.
Detailed description
Root Canal Treatment After inferior alveolar nervus block anesthesia with 4% Articaine with 1:100,000 adrenaline, the tooth was isolated with a rubber dam. The access cavity was opened using high-speed diamond round burs under water cooling. The working length (WL) was set at 0.5 mm shorter than the 0.0 reading using a 15 K-type file and apex locator (Morita Root ZX, Japan) and checked with radiographs. The root canals were prepared with Resiproc (Resiproc, VDW, Munich, Germany) R25 and R40 files, respectively, at the WL using the crown down technique. A total of 20 mL of 2.5% sodium hypochlorite (NaOCl) was used with a 30-gauge needle (Max-i-Probe; Dentsply Sirona) during preparation. 5 mL of distilled water was left in the canal for 1 min to neutralize the effect of NaOCl, and then the root canals were irrigated with 3 ml of 17% ethylene diamine tetra acetic acid (EDTA). EDTA was activated for 3 × 20s with the EA 25/04 tip 2 mm shorter than the WL. The EA tip was used with 2-4 mm vertical strokes. The root canals were irrigated with 5 mL distilled water and dried with paper points.
The subjects were divided into four groups for root filling. Randomization was performed using online software (www.randomizer.org) with a four-block-sized block randomization technique to ensure even distribution between the groups (allocation ratio 1:1:1:1). A co-investigator managed the allocation and reported the allocated treatment procedure to the operator. The operator could not be blinded due to the different stages of the treatment protocols. The patients were blinded to the chosen root canal sealer and activation protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AH Plus-NA | Experimental | Procedure: Root canal treatment (AH Plus-NA)AH Plus was mixed according to the manufacturer's instructions. The R40 gutta-percha (VDW) was coated with the sealer and inserted into the canal, and the root canals were filled using the single cone technique (SCT). The sealer was not activated. |
| AH Plus- EA | Experimental | Procedure: Root canal treatment (AH Plus-EA)An EA 25/04 tip was coated with AH Plus and activated in the root canals for 10 seconds. Then, the R40 gutta-percha was coated with the sealer and inserted into the canal, and the root canals were filled using SCT. |
| BC-NA | Experimental | Procedure: Root canal treatment (BC-NA)The ready-to-use EndoSequence BC was injected into the root canals and no activation was performed. Then, the R40 gutta-percha was inserted into the canali and the root canals were filled using SCT. |
| BC-EA | Experimental | Procedure: Root canal treatment (BC-EA)EndoSequence BC was injected into the root canals. An EA 25/04 tip was inserted 2 mm beyond the WL and activated for 10 s. Then, the R40 gutta-percha was inserted into the canal and the root canals were filled using SCT. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Mandibular first and second premolar teeth diagnosed with asymptomatic apical periodontitis
- Single rooted teeth with a single canal.
Key exclusion criteria (7 listed)
- Previous root canal treatment
- Use of any analgesic or antibiotics in the last 7 days
- Symptomatic teeth
- Sinus tract
- Presence of advanced periodontal problem (probing depth >4 mm)
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 |
|---|---|---|
| Root canal treatment (AH Plus-NA)Root canal treatment procedures explained in arm descriptions. | Procedure or surgery | AH Plus-NA |
| Root canal treatment (AH Plus-EA)Root canal treatment procedures explained in arm descriptions. | Procedure or surgery | AH Plus- EA |
| Root canal treatment (BC-NA)Root canal treatment procedures explained in arm descriptions. | Procedure or surgery | BC-NA |
| Root canal treatment (BC-EA)Root canal treatment procedures explained in arm descriptions. | Procedure or surgery | BC-EA |
Primary outcome
post operative pain
Time frame: 1 week
All participants were given a questionnaire based on a 0-10 numeric rating scale (NRS), with 0 indicating no pain and 10 indicating the worst pain. Patients recorded their pain on days 1, 2, 3 and 7 after treatment. Pain intensity was rated into 4 categories using the NRS. None: (NRS 0); Mild (NRS 1-3); Moderate (NRS 4-7); Severe (NRS 8-10).
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 9 May 2024.
- Results publication: PubMed 31794999Fonseca B, Coelho MS, Bueno CEDS, Fontana CE, Martin AS, Rocha DGP. Assessment of Extrusion and Postoperative Pain of a Bioceramic and Resin-Based Root Canal Sealer. Eur J Dent. 2019 Jul;13(3):343-348. doi: 10.1055/s-0039-3399457. Epub 2019 Dec 3.
- Results publication: PubMed 32915346Gundogar M, Sezgin GP, Kaplan SS, Ozyurek H, Uslu G, Ozyurek T. Postoperative pain after different irrigation activation techniques: a randomized, clinical trial. Odontology. 2021 Apr;109(2):385-392. doi: 10.1007/s10266-020-00553-5. Epub 2020 Sep 11.
- Results publication: PubMed 32929721Aslan 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.
- Results publication: PubMed 29571915Graunaite 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 publication: PubMed 28543092Wiesse PEB, Silva-Sousa YT, Pereira RD, Estrela C, Domingues LM, Pecora JD, Sousa-Neto MD. Effect of ultrasonic and sonic activation of root canal sealers on the push-out bond strength and interfacial adaptation to root canal dentine. Int Endod J. 2018 Jan;51(1):102-111. doi: 10.1111/iej.12794. Epub 2017 Jun 19.
- Results publication: PubMed 31508791Lopes FC, Zangirolami C, Mazzi-Chaves JF, Silva-Sousa AC, Crozeta BM, Silva-Sousa YTC, Sousa-Neto MD. Effect of sonic and ultrasonic activation on physicochemical properties of root canal sealers. J Appl Oral Sci. 2019 Sep 9;27:e20180556. doi: 10.1590/1678-7757-2018-0556.
- Derived from this study: PubMed 39443924Yilmaz K, Sari M. Influence of sonic activation of epoxy-resin and calcium silicate sealer on postoperative pain: a patient-blinded, parallel group, randomized clinical trial. BMC Oral Health. 2024 Oct 23;24(1):1268. doi: 10.1186/s12903-024-05049-0.
- Individual participant dataSharing planned: No
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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 Root canal treatment (AH Plus-NA), Root canal treatment (AH Plus-EA) and Root canal treatment (BC-NA) in people with Post Operative Pain and Apical Periodontitis, run by Mustafa Kemal University at 1 site 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 2 inclusion and 7 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 9 May 2024. 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 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?
post operative pain (time frame: 1 week). 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 NCT06403293, which also lists 7 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 9 May 2024.