Necrotic PulpPhase 2/3NCT05419752
Clinical Assessment of 3 Differant Obturation Sealers on Postoprative Pain and Swelling
A Phase 2/3 study testing bioceramic sealer, MTA and resin sealer in people with Necrotic Pulp and Single Root Teeth, run by Cairo University.
Trial summary
aim of the study will be conducted to compare the effect of MTA fill apex sealer and endo sequence bioceramic sealer in obturation on the intenisty of postoperative pain and the incidence of post operative swelling in patient with necrotic teeth . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp, Single Root Teeth
- What is being tested?
- bioceramic sealer, MTA and resin sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2022to 30 Aug 2022
- Phase
- Phase 2/3
- 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
- Patients requiring root canal treatment of single canal necrotic teeth.
- Patient from 18 to 60 years old
- Patients with Asymptomatic apical periodontitis.
- Teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al
Who cannot join
- Teeth with incompletely formed apex
- Teeth requiring retreatment
- Patients having complicating systemic disease such as diabetes, malignancy, pregnancy, central nervous system disorders, Cardiovascular system disorders, respiratory disorders, asthma patients, psychiatric disorders, immunocompromised patients
- Patients taking anti-inflammatory or antibiotics
- Patients giving history of analgesic or antibiotic intake 1 week before treatment
- Patients below 18 years of age
Show all 9Show fewer
- Patients above 65 years of age
- Patients having history of peptic ulcer or gastrointestinal bleeding
- Teeth affected with periodontal disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of 3 Different Root Canal Obturating Sealers on Postoperative Pain and Swelling in Single Canal Necrotic Teeth With a Single Visit .a Randomized Controlled Trial
aim of the study will be conducted to compare the effect of MTA fill apex sealer and endo sequence bioceramic sealer in obturation on the intenisty of postoperative pain and the incidence of post operative swelling in patient with necrotic teeth .
- Conditions
- Necrotic Pulp, Single Root Teeth
- Being tested
- bioceramic sealer, MTA, resin sealer
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioceramic sealerDrug
Also called endosequence
bioceramic based obturating sealer
MTADrug
Also called MTA fill apex
MTA based obturating sealer
resin sealerDrug
Also called AH Plus resin sealer
resin based obturating sealer
| Study group | Role | What they receive |
|---|---|---|
| endo sequence bioceramic sealer | Experimental | obturation using Endo-sequence BC sealer Receives: Drug: bioceramic sealer |
| MTA fill apex calcium silicate base sealer | Experimental | obturation using calcium-silicates based MTA fill-apex sealer Receives: Drug: MTA |
| AH plus resin sealer | Experimental | obturation using AH Plus sealer Receives: Drug: resin sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of post-operative pain
Measurement of post-operative pain by Visual analogue scale
Measured: 6 hours
Intensity of post-operative pain
Measurement of post-operative pain by Visual analogue scale
Measured: 12 hours
Intensity of post-operative pain
Measurement of post-operative pain by Visual analogue scale
Measured: 24 hours
Intensity of post-operative pain
Measurement of post-operative pain by Visual analogue scale
Measured: 48 hours
Intensity of post-operative pain
Measurement of post-operative pain by Visual analogue scale
Measured: 72 hours
Secondary outcomes (1)
post operative swelling
Yes or no yes or no
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start30 Jul 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies of the same condition, open and under way.
- More trials run by Cairo 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Hany Elsayed Attia Elmasry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419752
- Sponsor's protocol ID
- ENDO 23/5/2022
- Status last verified
- Jun 2022
- First submitted
- 27 May 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of 3 Different Root Canal Obturating Sealers on Postoperative Pain and Swelling in Single Canal Necrotic Teeth With a Single Visit .a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05419752
- Acronym / sponsor ID
- ENDO 23/5/2022
- Conditions
- Necrotic Pulp, Single Root Teeth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 15 Jun 2022 (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 of the study will be conducted to compare the effect of MTA fill apex sealer and endo sequence bioceramic sealer in obturation on the intenisty of postoperative pain and the incidence of post operative swelling in patient with necrotic teeth .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| endo sequence bioceramic sealer | Experimental | Drug: bioceramic sealerobturation using Endo-sequence BC sealer |
| MTA fill apex calcium silicate base sealer | Experimental | Drug: MTAobturation using calcium-silicates based MTA fill-apex sealer |
| AH plus resin sealer | Experimental | Drug: resin sealerobturation using AH Plus sealer |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients requiring root canal treatment of single canal necrotic teeth.
- Patient from 18 to 60 years old
- Patients with Asymptomatic apical periodontitis.
- Teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al
Key exclusion criteria (9 listed)
- Teeth with incompletely formed apex
- Patients above 65 years of age
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 |
|---|---|---|
| bioceramic sealerAlso: endosequencebioceramic based obturating sealer | Drug | endo sequence bioceramic sealer |
| MTAAlso: MTA fill apexMTA based obturating sealer | Drug | MTA fill apex calcium silicate base sealer |
| resin sealerAlso: AH Plus resin sealerresin based obturating sealer | Drug | AH plus resin sealer |
Primary outcome
Intensity of post-operative pain
Time frame: 6 hours
Measurement of post-operative pain by Visual analogue scale
Intensity of post-operative pain
Time frame: 12 hours
Measurement of post-operative pain by Visual analogue scale
Intensity of post-operative pain
Time frame: 24 hours
Measurement of post-operative pain by Visual analogue scale
Intensity of post-operative pain
Time frame: 48 hours
Measurement of post-operative pain by Visual analogue scale
Intensity of post-operative pain
Time frame: 72 hours
Measurement of post-operative pain by Visual analogue scale
1 secondary outcome
post operative swelling
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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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 Phase 2/3 study testing bioceramic sealer, MTA and resin sealer in people with Necrotic Pulp and Single Root Teeth, run by Cairo 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 9 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 15 Jun 2022. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Elsayed Hany Elmasry, bsc (00201159536873, elsayed.hany@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of post-operative pain (time frame: 6 hours). The study lists 5 primary outcomes in all. 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 15 Jun 2022.