Endodontically-Treated TeethNCT03029520
Post-Obturation Pain Following the Use of the AH Plus and iRoot SP Sealers
A study testing Root canal obturation with iRoot SP sealer and Root canal obturation with AH Plus Sealer in people with Endodontically-Treated Teeth, run by Cukurova University.
Trial summary
The aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers. In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically-Treated Teeth
- What is being tested?
- Root canal obturation with iRoot SP sealer and Root canal obturation with AH Plus Sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jan 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no systemic diseases
- women were not pregnant or breastfeeding status
- no history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment.
- all selected teeth were mandibular molar or mandibular premolar.
Who cannot join
- systemic and/or periodontal disease;
- allergy to local anesthetic agents and/or history of intolerance to nonsteroidal anti-inflammatory drugs;
- requirement for antibiotic prophylaxis
- open tooth apex
- pacemaker use
About this study
Official title: Termoplastik Kor tekniğini Iki farklı Kanal patı Ile kullanıp Tedavi sonrası Hassasiyet ve kök Ucundan taşma miktarının değerlendirilmesi: Randomize kontrollü Klinik çalışma
The aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers.
In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. Patients with vital and devital teeth were assigned to four groups using a randomized block design with block sizes of 10 patients each. The groups were composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator prepared root canals and filled them with sealer using the carrier-based obturation technique. Radiographs were taken and obturation length was recorded. Patients recorded pain scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6, 6-12, 12-24, and 24-72 h..
Read the detailed description
This randomized controlled clinical study was conducted to compare the incidence and intensity of post-obturation pain, evaluate the overextension of filling material radiographically, and assess the relationship between pain and analgesic intake in patients with vital and devital teeth undergoing carrier-based obturation with two different sealers (iRoot SP, AH Plus)
- Conditions
- Endodontically-Treated Teeth
- Being tested
- Root canal obturation with iRoot SP sealer, Root canal obturation with AH Plus Sealer
- Keywords
- Endodontic Postoperative Pain, iRoot SP Sealer, Randomized Clinical Trial, Herofill carrier-based obturation
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal obturation with iRoot SP sealerOther
Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.
Root canal obturation with AH Plus SealerOther
Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.
| Study group | Role | What they receive |
|---|---|---|
| pain iRoot SP sealer Vital Pulp | Active comparator | Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) vital pulp. Receives: Other: Root canal obturation with iRoot SP sealer |
| pain iRoot SP sealer Devital pulp | Active comparator | Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) devital pulp. Receives: Other: Root canal obturation with iRoot SP sealer |
| pain AHPlus Vital pulp | Active comparator | Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) vital pulp. Receives: Other: Root canal obturation with AH Plus Sealer |
| pain AHPlus Devital Pulp | Active comparator | Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) devital pulp. Receives: Other: Root canal obturation with AH Plus Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative pain by using VAS scale after obturation with different sealers.
Measured: 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically-Treated TeethStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayfer Atav Ateş, Cukurova University
- Investigators
- oguz yoldas, professor, Study chair, vice dean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029520
- Sponsor's protocol ID
- BAPKOM 4949
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The study will be shared at Turkish Council of Higher education thesis center
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Termoplastik Kor tekniğini Iki farklı Kanal patı Ile kullanıp Tedavi sonrası Hassasiyet ve kök Ucundan taşma miktarının değerlendirilmesi: Randomize kontrollü Klinik çalışma
- ClinicalTrials.gov ID
- NCT03029520
- Acronym / sponsor ID
- BAPKOM 4949
- Conditions
- Endodontically-Treated Teeth
- Keywords
- Endodontic Postoperative Pain, iRoot SP Sealer, Randomized Clinical Trial, Herofill carrier-based obturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Jan 2017 (estimated)
- 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.
The aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers.
In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. Patients with vital and devital teeth were assigned to four groups using a randomized block design with block sizes of 10 patients each. The groups were composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator prepared root canals and filled them with sealer using the carrier-based obturation technique. Radiographs were taken and obturation length was recorded. Patients recorded pain scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6, 6-12, 12-24, and 24-72 h..
Detailed description
This randomized controlled clinical study was conducted to compare the incidence and intensity of post-obturation pain, evaluate the overextension of filling material radiographically, and assess the relationship between pain and analgesic intake in patients with vital and devital teeth undergoing carrier-based obturation with two different sealers (iRoot SP, AH Plus)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pain iRoot SP sealer Vital Pulp | Active comparator | Other: Root canal obturation with iRoot SP sealerEvaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) vital pulp. |
| pain iRoot SP sealer Devital pulp | Active comparator | Other: Root canal obturation with iRoot SP sealerEvaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) devital pulp. |
| pain AHPlus Vital pulp | Active comparator | Other: Root canal obturation with AH Plus SealerEvaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) vital pulp. |
| pain AHPlus Devital Pulp | Active comparator | Other: Root canal obturation with AH Plus SealerEvaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) devital pulp. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no systemic diseases
- women were not pregnant or breastfeeding status
- no history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment.
- all selected teeth were mandibular molar or mandibular premolar.
Key exclusion criteria (5 listed)
- systemic and/or periodontal disease;
- allergy to local anesthetic agents and/or history of intolerance to nonsteroidal anti-inflammatory drugs;
- requirement for antibiotic prophylaxis
- open tooth apex
- pacemaker use
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 obturation with iRoot SP sealerPostoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps. | Other | pain iRoot SP sealer Devital pulp, pain iRoot SP sealer Vital Pulp |
| Root canal obturation with AH Plus SealerPostoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps. | Other | pain AHPlus Devital Pulp, pain AHPlus Vital pulp |
Primary outcome
The incidence of postoperative pain by using VAS scale after obturation with different sealers.
Time frame: 72 hour
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 25 Jan 2017.
- Individual participant dataSharing planned: Yes. The study will be shared at Turkish Council of Higher education thesis center
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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.
oguz yoldas, professor study chair
vice dean
Questions about this trial
What is this clinical trial studying?
A study testing Root canal obturation with iRoot SP sealer and Root canal obturation with AH Plus Sealer in people with Endodontically-Treated Teeth, run by Cukurova 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 4 inclusion and 5 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 25 Jan 2017. 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?
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?
The incidence of postoperative pain by using VAS scale after obturation with different sealers. (time frame: 72 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2017.