Irreversible PulpitisNCT02981693
Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study
A study testing Root canal sealer in people with Irreversible Pulpitis and Apical Periodontitis, run by Hui Chen.
Trial summary
The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Apical Periodontitis
- What is being tested?
- Root canal sealer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects were required to:
- have a mature tooth with closed apices;
- have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
- be prepared to appear for follow-up and
- sign informed consent form.
Who cannot join
- Subjects with:
- moderate or severe marginal periodontitis;
- internal or external root resorption in periapical radiograph;
- active systemic disease;
- physical or mental disability,
- pregnant or lactating
About this study
Official title: 1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study
The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the arms.
- Conditions
- Irreversible Pulpitis, Apical Periodontitis
- Being tested
- Root canal sealer
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal sealerProcedure or surgery
Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm.
| Study group | Role | What they receive |
|---|---|---|
| iRoot SP sealer | Experimental | iRoot SP sealer was used as root canal sealer in root canal obturation. Receives: Procedure: Root canal sealer |
| AH Plus sealer | Active comparator | AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation. Receives: Procedure: Root canal sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographical assessments
The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed".
Measured: 1 year after root canal therapy
Secondary outcomes (2)
Clinical assessments
The root filled tooth was considered clinically successful if there was absence of clinical sign or symptom such as spontaneous pain, sensitivity to percussion or palpation, abnormal mobility, signs of pathology like abscess or sinus tract.
Measured: 1 year after root canal therapy
Postoperative Pain Evaluation
Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.
Measured: 1 week after root canal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Chen, The Dental Hospital of Zhejiang University School of Medicine
- Investigators
- Hui Chen, Study chair, Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981693
- Sponsor's protocol ID
- DHZhejiangU
- Status last verified
- Nov 2016
- First submitted
- 27 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02981693
- Acronym / sponsor ID
- DHZhejiangU
- Conditions
- Irreversible Pulpitis, Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Hui ChenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Dec 2016 (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 purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iRoot SP sealer | Experimental | Procedure: Root canal sealeriRoot SP sealer was used as root canal sealer in root canal obturation. |
| AH Plus sealer | Active comparator | Procedure: Root canal sealerAH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- have a mature tooth with closed apices;
- have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
- be prepared to appear for follow-up and
- sign informed consent form.
Key exclusion criteria (6 listed)
- moderate or severe marginal periodontitis;
- internal or external root resorption in periapical radiograph;
- active systemic disease;
- physical or mental disability,
- pregnant or lactating
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 sealerPatients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm. | Procedure or surgery | AH Plus sealer, iRoot SP sealer |
Primary outcome
Radiographical assessments
Time frame: 1 year after root canal therapy
The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed".
2 secondary outcomes
Clinical assessments
Time frame: 1 year after root canal therapy
Postoperative Pain Evaluation
Time frame: 1 week after root canal therapy
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 5 Dec 2016.
Related trials for Irreversible Pulpitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
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.
Hui Chen study chair
Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing Root canal sealer in people with Irreversible Pulpitis and Apical Periodontitis, run by Hui Chen.
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 5 inclusion and 6 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 5 Dec 2016. 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?
Radiographical assessments (time frame: 1 year after root canal therapy). 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 5 Dec 2016.