Apical PeriodontitisPhase 4NCT04249206
Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer
A Phase 4 study testing Root Canal Treatment in people with Apical Periodontitis, run by Cittadella Universitaria.
Trial summary
The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Root Canal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to Dec 2021
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a permanent, single or multi-rooted mature tooth
- clinical diagnosis of irreversible pulpitis
- diagnosis of apical periodontitis
Who cannot join
- subjects with immune-compromised status
- subjects with an overall poor prognosis for their treatment
About this study
The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.
- Conditions
- Apical Periodontitis
- Being tested
- Root Canal Treatment
- Keywords
- root canal obturation, hydraulic sealer, single cone, endodontic outcome
- 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 TreatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hydraulic Sealer Group | Experimental | The single-cone obturation technique is based on a master cone of gutta-percha in conjunction with a hydraulic sealer.
Hydraulic endodontic cements exhibit excellent hydraulic properties, biocompatibility and bioactivity. Receives: Procedure: Root Canal Treatment |
| Zinc oxide-eugenol Sealer Group | Active comparator | The continuous wave of condensation of gutta-percha and a zinc oxide-eugenol (ZOE) sealer is a gold standard in endodontic obturation. Receives: Procedure: Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical Healing
Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score <2)
Measured: 4 year
Secondary outcomes (1)
tooth survival
Success was defined if the tooth was asymptomatic and considered to be functional regardless of its PAI score
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 May 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 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 Apical PeriodontitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cittadella Universitaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Bardini, Cittadella Universitaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249206
- Sponsor's protocol ID
- ETEBCB
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bardini G, Casula L, Ambu E, Musu D, Mercade M, Cotti E. A 12-month follow-up of primary and secondary root canal treatment in teeth obturated with a hydraulic sealer. Clin Oral Investig. 2021 May;25(5):2757-2764. doi: 10.1007/s00784-020-03590-0. Epub 2020 Sep 28.
PubMed 32989597
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer
- ClinicalTrials.gov ID
- NCT04249206
- Acronym / sponsor ID
- ETEBCB
- Conditions
- Apical Periodontitis
- Keywords
- root canal obturation, hydraulic sealer, single cone, endodontic outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cittadella UniversitariaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Jan 2020 (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.
The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydraulic Sealer Group | Experimental | Procedure: Root Canal TreatmentThe single-cone obturation technique is based on a master cone of gutta-percha in conjunction with a hydraulic sealer. Hydraulic endodontic cements exhibit excellent hydraulic properties, biocompatibility and bioactivity. |
| Zinc oxide-eugenol Sealer Group | Active comparator | Procedure: Root Canal TreatmentThe continuous wave of condensation of gutta-percha and a zinc oxide-eugenol (ZOE) sealer is a gold standard in endodontic obturation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a permanent, single or multi-rooted mature tooth
- clinical diagnosis of irreversible pulpitis
- diagnosis of apical periodontitis
Key exclusion criteria (2 listed)
- subjects with immune-compromised status
- subjects with an overall poor prognosis for their treatment
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 | Procedure or surgery | Hydraulic Sealer Group, Zinc oxide-eugenol Sealer Group |
Primary outcome
Periapical Healing
Time frame: 4 year
Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score <2)
1 secondary outcome
tooth survival
Time frame: 4 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 32989597Bardini G, Casula L, Ambu E, Musu D, Mercade M, Cotti E. A 12-month follow-up of primary and secondary root canal treatment in teeth obturated with a hydraulic sealer. Clin Oral Investig. 2021 May;25(5):2757-2764. doi: 10.1007/s00784-020-03590-0. Epub 2020 Sep 28.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Root Canal Treatment in people with Apical Periodontitis, run by Cittadella Universitaria.
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 3 inclusion and 2 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 30 Jan 2020. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Periapical Healing (time frame: 4 year). 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 NCT04249206, 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 30 Jan 2020.