Postoperative PainNCT05033093
Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain
A study testing Root Canal Sealants in people with Postoperative Pain, run by Yuzuncu Yil University.
Trial summary
After endodontic procedures, depending on the individual and many variables, postoperative pain can be occur within hours and continue for days following the treatment. It is thought that acute inflammation that develops due to chemical, mechanical or microbial injuries in the periapical tissue after endodontic… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Root Canal Sealants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Dec 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Who cannot join
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain: A Randomized Controlled Clinical Study
After endodontic procedures, depending on the individual and many variables, postoperative pain can be occur within hours and continue for days following the treatment. It is thought that acute inflammation that develops due to chemical, mechanical or microbial injuries in the periapical tissue after endodontic treatment causes postoperative pain. Materials used for root canal obturation can reach periodontal tissues through the apical foramen, lateral canals or leakage and may affect the healing process in the periodontium. For this reason, knowing the properties of root canal obturation materials is important in terms of preventing postoperative pain.
Calcium silicate-based root canal sealer are recommended to be used as they enhance healing after endodontic treatment by promoting differentiation of odontoblasts and the release of bioactive compounds. At the same time, it has been reported that it has less cytotoxic effect compared to the resin-based AH Plus, which is widely used for root canal). Silicone-based root canal sealers have good biological properties on human ligament periodontal fibroblasts. It has been reported that GuttaFlow Bioseal root canal sealer, which has been used in recent years, has less cytotoxic effect than GuttaFlow2, MTA Fillapex and AH Plus sealers. Ateş et al.(2019) evaluated that the effects of different root canal sealers on postoperative pain and reported that the use of iRoot SP or AH Plus did not significantly affect pain levels, but iRoot SP sealer required less analgesic intake than AH Plus sealer. Aslan et al. (2020) concluded in their study that calcium silicate and resin-based root canal sealers are similar in terms of postoperative pain and need for analgesic intake. Ferreira et al.(2020) compared the effects of AH Plus, Endofill and MTA Fillapex root canal sealers on postoperative pain and stated that all three root canal sealers cause similar pain levels.
When reviewing the studies on postoperative pain, it is seen that mostly resin and calcium silicate based root canal sealers are evaluated. Studies on calcium silicate and silicone-based root canal sealers seem to focus more on cytotoxicity. However, no study has been found in the literature on the effect of GuttaFlow Bioseal sealer on postoperative pain, which has been popularity in recent years and has low cytotoxicity. Acoording to this information, it is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain.
Read the detailed description
The study is planned to be carried out on 84 patients who were diagnosed and followed up in Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Endodontics, aged between 18-50 years, without any systemic disease. Patients diagnosed with irreversible pulpitis will be included in the study group. Patients with periapical lesions and open apex teeth will not be included in the study group. Before the treatment, pain levels of patients will be record according to the VAS scale.
Dental anesthesia will be achieved using local anesthetic solution (Maxicaine DS fort, Vem, Istanbul, Turkey) for inferior alveolar nerve blockade. After rubber dam isolation, endodontic access cavity will be prepared using high-speed burs. The working length will be determined with using apex locator (Propex Pixi, Dentsply Maillefer) and periapical radiographs with placing a #15 K-file (VDW GmbH, Munich, Germany) into the root canals at the end of the apical narrowing. The root canals will be mechanically prepared using ProTaperNext (DentsplyMaillefer,Baillagues,Switzerland) up to the X3 numbered instrument as standard in each patient. During instrumentation, irrigation will be performed with 2 mL 5.25% NaOCl (Microvem AF, İstanbul, Türkey) at each file change. A dental injector and a 27 gauge dental needle tip will be used for irrigation. The tip of the cannulas will be adjusted to reach two-thirds of the working size. According to the final irrigation procedure, all canals will be irrigated with 5 mL of 17% EDTA solution (Imicryl, Konya, Turkey), 5 mL of 5.25% NaOCI solution and 5 mL of saline, respectively.
After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer (G1: AH Plus; G2: iRoot SP; G3: GuttaFlow Bioseal) to be used in the obturation process (n: 28). All groups will be filled with sterile gutta-percha and root canal sealers in the same session using the single-cone technique. Teeth with completed root canal treatment will be restored with coronal sealing. After the treatment, patients in all three groups will be asked to report their pain levels according to the VAS scale at certain intervals (6th hour - 24th hour - 48. hour - 72. hour - 1st week) and their need of analgesic use. According to the questionnaires collected with patient feedback, pain levels will be evaluated after root canal treatment completed in a single session.
Descriptive statistics in terms of the features emphasized; It will be expressed as Average, Standard Deviation, Minimum and Maximum value. In order to compare the groups and Times (6, 24, 48, 72nd Hour and 1st Week) in terms of these characteristics, directional analysis of variance with two factors and one factor repeated, will be used. Duncan test will be used to identify different groups following analysis of variance. In determining the relationship between these variables, Pearson correlation coefficients will be calculated separately for the groups. Statistical significance level will be taken as 5% in calculations and SPSS statistical package program will be used for calculations.
- Conditions
- Postoperative Pain
- Being tested
- Root Canal Sealants
- Keywords
- root canal, root canal sealer, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Canal SealantsDrug
it is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| Ah Plus | Active comparator | All samples will be filled with Ah Plus root canal sealer and gutta percha Receives: Drug: Root Canal Sealants |
| I Root SP | Active comparator | All samples will be filled with I Root SP root canal sealer and gutta percha Receives: Drug: Root Canal Sealants |
| GuttaFlow Bioseal | Active comparator | All samples will be filled with GuttaFlow Bioseal canal sealer and gutta percha Receives: Drug: Root Canal Sealants |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Scala
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
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 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
- Model description
- After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer ; G1: AH Plus G2: iRoot SP G3: GuttaFlow Bioseal to be used in the obturation process (n: 28).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Özlek, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033093
- Sponsor's protocol ID
- 19/29.04.2021
- Status last verified
- Aug 2021
- First submitted
- 26 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer (G1: AH Plus; G2: iRoot SP; G3: GuttaFlow Bioseal) to be used in the obturation process (n: 28). All groups will be filled with sterile gutta-percha and root canal sealers in the same session using the single-cone technique. Teeth with completed root canal treatment will be restored with coronal sealing. After the treatment, patients in all three groups will be asked to report their pain levels according to the VAS scale at certain intervals (6th hour - 24th hour - 48. hour - 72. hour - 1st week) and their need of analgesic use. According to the questionnaires collected with patient feedback, pain levels will be evaluated after root canal treatment completed in a single session.
Publications
Graunaite 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 29571915
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05033093
- Acronym / sponsor ID
- 19/29.04.2021
- Conditions
- Postoperative Pain
- Keywords
- root canal, root canal sealer, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 2 Sep 2021 (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.
After endodontic procedures, depending on the individual and many variables, postoperative pain can be occur within hours and continue for days following the treatment. It is thought that acute inflammation that develops due to chemical, mechanical or microbial injuries in the periapical tissue after endodontic treatment causes postoperative pain. Materials used for root canal obturation can reach periodontal tissues through the apical foramen, lateral canals or leakage and may affect the healing process in the periodontium. For this reason, knowing the properties of root canal obturation materials is important in terms of preventing postoperative pain.
Calcium silicate-based root canal sealer are recommended to be used as they enhance healing after endodontic treatment by promoting differentiation of odontoblasts and the release of bioactive compounds. At the same time, it has been reported that it has less cytotoxic effect compared to the resin-based AH Plus, which is widely used for root canal). Silicone-based root canal sealers have good biological properties on human ligament periodontal fibroblasts. It has been reported that GuttaFlow Bioseal root canal sealer, which has been used in recent years, has less cytotoxic effect than GuttaFlow2, MTA Fillapex and AH Plus sealers. Ateş et al.(2019) evaluated that the effects of different root canal sealers on postoperative pain and reported that the use of iRoot SP or AH Plus did not significantly affect pain levels, but iRoot SP sealer required less analgesic intake than AH Plus sealer. Aslan et al. (2020) concluded in their study that calcium silicate and resin-based root canal sealers are similar in terms of postoperative pain and need for analgesic intake. Ferreira et al.(2020) compared the effects of AH Plus, Endofill and MTA Fillapex root canal sealers on postoperative pain and stated that all three root canal sealers cause similar pain levels.
When reviewing the studies on postoperative pain, it is seen that mostly resin and calcium silicate based root canal sealers are evaluated. Studies on calcium silicate and silicone-based root canal sealers seem to focus more on cytotoxicity. However, no study has been found in the literature on the effect of GuttaFlow Bioseal sealer on postoperative pain, which has been popularity in recent years and has low cytotoxicity. Acoording to this information, it is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain.
Detailed description
The study is planned to be carried out on 84 patients who were diagnosed and followed up in Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Endodontics, aged between 18-50 years, without any systemic disease. Patients diagnosed with irreversible pulpitis will be included in the study group. Patients with periapical lesions and open apex teeth will not be included in the study group. Before the treatment, pain levels of patients will be record according to the VAS scale.
Dental anesthesia will be achieved using local anesthetic solution (Maxicaine DS fort, Vem, Istanbul, Turkey) for inferior alveolar nerve blockade. After rubber dam isolation, endodontic access cavity will be prepared using high-speed burs. The working length will be determined with using apex locator (Propex Pixi, Dentsply Maillefer) and periapical radiographs with placing a #15 K-file (VDW GmbH, Munich, Germany) into the root canals at the end of the apical narrowing. The root canals will be mechanically prepared using ProTaperNext (DentsplyMaillefer,Baillagues,Switzerland) up to the X3 numbered instrument as standard in each patient. During instrumentation, irrigation will be performed with 2 mL 5.25% NaOCl (Microvem AF, İstanbul, Türkey) at each file change. A dental injector and a 27 gauge dental needle tip will be used for irrigation. The tip of the cannulas will be adjusted to reach two-thirds of the working size. According to the final irrigation procedure, all canals will be irrigated with 5 mL of 17% EDTA solution (Imicryl, Konya, Turkey), 5 mL of 5.25% NaOCI solution and 5 mL of saline, respectively.
After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer (G1: AH Plus; G2: iRoot SP; G3: GuttaFlow Bioseal) to be used in the obturation process (n: 28). All groups will be filled with sterile gutta-percha and root canal sealers in the same session using the single-cone technique. Teeth with completed root canal treatment will be restored with coronal sealing. After the treatment, patients in all three groups will be asked to report their pain levels according to the VAS scale at certain intervals (6th hour - 24th hour - 48. hour - 72. hour - 1st week) and their need of analgesic use. According to the questionnaires collected with patient feedback, pain levels will be evaluated after root canal treatment completed in a single session.
Descriptive statistics in terms of the features emphasized; It will be expressed as Average, Standard Deviation, Minimum and Maximum value. In order to compare the groups and Times (6, 24, 48, 72nd Hour and 1st Week) in terms of these characteristics, directional analysis of variance with two factors and one factor repeated, will be used. Duncan test will be used to identify different groups following analysis of variance. In determining the relationship between these variables, Pearson correlation coefficients will be calculated separately for the groups. Statistical significance level will be taken as 5% in calculations and SPSS statistical package program will be used for calculations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer ; G1: AH Plus G2: iRoot SP G3: GuttaFlow Bioseal to be used in the obturation process (n: 28).
| Arm | Type | Receives |
|---|---|---|
| Ah Plus | Active comparator | Drug: Root Canal SealantsAll samples will be filled with Ah Plus root canal sealer and gutta percha |
| I Root SP | Active comparator | Drug: Root Canal SealantsAll samples will be filled with I Root SP root canal sealer and gutta percha |
| GuttaFlow Bioseal | Active comparator | Drug: Root Canal SealantsAll samples will be filled with GuttaFlow Bioseal canal sealer and gutta percha |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Key exclusion criteria (7 listed)
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
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 Sealantsit is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain | Drug | Ah Plus, GuttaFlow Bioseal, I Root SP |
Primary outcome
VAS Scala
Time frame: up to 7 days
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Background: 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.
- Individual participant dataSharing planned: No. After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer (G1: AH Plus; G2: iRoot SP; G3: GuttaFlow Bioseal) to be used in the obturation process (n: 28). All groups will be filled with sterile gutta-percha and root canal sealers in the same session using the single-cone technique. Teeth with completed root canal treatment will be restored with coronal sealing. After the treatment, patients in all three groups will be asked to report their pain levels according to the VAS scale at certain intervals (6th hour - 24th hour - 48. hour - 72. hour - 1st week) and their need of analgesic use. According to the questionnaires collected with patient feedback, pain levels will be evaluated after root canal treatment completed in a single session.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Root Canal Sealants in people with Postoperative Pain, run by Yuzuncu Yil University.
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: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacer Şahin Aydınyurt, PhdD (905304589710, hacersahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Scala (time frame: up to 7 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 NCT05033093, 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 2 Sep 2021.