Periapical AbscessPhase 4NCT04198298
Prospective Clinical Trial of Three Apical Sealing Materials
A Phase 4 study testing EndoSequence, ProRoot MTA and Biodentine in people with Periapical Abscess, run by University of the Pacific.
Trial summary
This prospective comparative randomized clinical trial compares healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periapical Abscess
- What is being tested?
- EndoSequence, ProRoot MTA and Biodentine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2014to 31 May 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients, American Society of Anesthesiologists (ASA) classification I and II
- Any tooth with a single chronic periapical lesion requiring apical microsurgery
- Informed consent signed prior to surgery
Who cannot join
- Background of drug/alcohol abuse
- Adjacent periapical lesion
- Periodontal disease
About this study
Official title: Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials
This prospective comparative randomized clinical trial compares healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.
Read the detailed description
A prospective comparative randomized clinical trial was designed to evaluate the healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials (EndoSequence®, ProRoot® MTA, or Biodentine®) following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.
- Conditions
- Periapical Abscess
- Being tested
- EndoSequence, ProRoot MTA, Biodentine
- Keywords
- Cone-Beam Computed Tomography, Microsurgery, Bone Regeneration, Biocompatible Materials
- Medical subject headings
- Periapical Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoSequenceDrug
Also called EndoSequence®
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
ProRoot MTADrug
Also called ProRoot® MTA
The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
BiodentineDrug
Also called Biodentine®
The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 EndoSequence | Active comparator | The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex. Receives: Drug: EndoSequence |
| Group 2 ProRoot MTA | Active comparator | The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex. Receives: Drug: ProRoot MTA |
| Group 3 Biodentine | Active comparator | The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex. Receives: Drug: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of remineralization
The pace at which new bone is redeposited
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start2 Nov 2014
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical AbscessStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198298
- Sponsor's protocol ID
- 20-60
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials
- ClinicalTrials.gov ID
- NCT04198298
- Acronym / sponsor ID
- 20-60
- Conditions
- Periapical Abscess
- Keywords
- Cone-Beam Computed Tomography, Microsurgery, Bone Regeneration, Biocompatible Materials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 2 Nov 2014 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 13 Dec 2019 (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.
This prospective comparative randomized clinical trial compares healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.
Detailed description
A prospective comparative randomized clinical trial was designed to evaluate the healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials (EndoSequence®, ProRoot® MTA, or Biodentine®) following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 EndoSequence | Active comparator | Drug: EndoSequenceThe EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex. |
| Group 2 ProRoot MTA | Active comparator | Drug: ProRoot MTAThe ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex. |
| Group 3 Biodentine | Active comparator | Drug: BiodentineThe Biodentine® retrograde sealing material was used to provide a biologic seal at the apex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients, American Society of Anesthesiologists (ASA) classification I and II
- Any tooth with a single chronic periapical lesion requiring apical microsurgery
- Informed consent signed prior to surgery
Key exclusion criteria (3 listed)
- Background of drug/alcohol abuse
- Adjacent periapical lesion
- Periodontal disease
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 |
|---|---|---|
| EndoSequenceAlso: EndoSequence®The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex. | Drug | Group 1 EndoSequence |
| ProRoot MTAAlso: ProRoot® MTAThe ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex. | Drug | Group 2 ProRoot MTA |
| BiodentineAlso: Biodentine®The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex. | Drug | Group 3 Biodentine |
Primary outcome
Rate of remineralization
Time frame: 6 months
The pace at which new bone is redeposited
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 13 Dec 2019.
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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 EndoSequence, ProRoot MTA and Biodentine in people with Periapical Abscess, run by University of the Pacific.
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 3 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 13 Dec 2019. 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?
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?
Rate of remineralization (time frame: 6 months). 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 13 Dec 2019.