Necrotic PulpEarly Phase 1NCT04646538
Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography
A Early Phase 1 study testing Regenerative Endodontics Procedures (REPs) in people with Necrotic Pulp and Periapical; Infection, run by Alexandria University at 1 site in Egypt.
Trial summary
3D volume assessment was done to evaluate the periapical healing following REPs in mature teeth. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp, Periapical; Infection
- What is being tested?
- Regenerative Endodontics Procedures (REPs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2017to 30 Dec 2018
- Phase
- Early Phase 1
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Necrotic Mature Maxillary anterior teeth with periapical lesions.
Who cannot join
- Patients with mobile and fractured teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3 D Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography
3D volume assessment was done to evaluate the periapical healing following REPs in mature teeth.
Read the detailed description
REPs were done for 10 mature maxillary necrotic teeth with periapical lesions confirmed by digital periapical radiographs. Instrumentation was done using Protaper Next till size X3 (size 30). Pre-operative radiographs also included CBCT scans to measure the 3D volume and area of the periapical lesion to be used as baseline data. The postoperative radiographic examination included: a) digital periapical radiographs taken at 3,6,9, and 12 months to monitor the lesion through out the follow-up period. b)CBCT scan to measure quantitatively the volume and area of the periapical lesion after 12 months follow up
- Conditions
- Necrotic Pulp, Periapical; Infection
- Being tested
- Regenerative Endodontics Procedures (REPs)
- Keywords
- REPs, CBCT, volume, Mature teeth
- Medical subject headings
- Dental Pulp Necrosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontics Procedures (REPs)Other
REPs was done for 10 mature maxillary necrotic teeth with periapical lesions. Instrumentation was done using Protaper Next system till size X3. Irrigation with 1.5 % NaOCl was done in the first visit. in the second visit, bleeding was induced in the canal by irritating the periapical area followed by the application of Biodentine as cervical plug then completion of the coronal restoration.
| Study group | Role | What they receive |
|---|---|---|
| X3 group | Experimental | Not described Receives: Other: Regenerative Endodontics Procedures (REPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement the volume of periapical lesion preoperatively and comparing it with the new volume after REPs using cone-beam computed tomography.
Measuring the volume in mm3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start5 Jun 2017
- Primary completion20 Aug 2018
- Study completion30 Dec 2018
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 Necrotic PulpStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mohamed El Kateb, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646538
- Sponsor's protocol ID
- 19832009
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kateb NME, Fata MM. Influence of periapical lesion size on healing outcome following regenerative endodontic procedures: a clinical investigation. Oral Radiol. 2022 Oct;38(4):480-489. doi: 10.1007/s11282-021-00578-8. Epub 2021 Nov 26.
PubMed 34826060
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3 D Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography
- ClinicalTrials.gov ID
- NCT04646538
- Acronym / sponsor ID
- 19832009
- Conditions
- Necrotic Pulp, Periapical; Infection
- Keywords
- REPs, CBCT, volume, Mature teeth
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 30 Nov 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.
3D volume assessment was done to evaluate the periapical healing following REPs in mature teeth.
Detailed description
REPs were done for 10 mature maxillary necrotic teeth with periapical lesions confirmed by digital periapical radiographs. Instrumentation was done using Protaper Next till size X3 (size 30). Pre-operative radiographs also included CBCT scans to measure the 3D volume and area of the periapical lesion to be used as baseline data. The postoperative radiographic examination included: a) digital periapical radiographs taken at 3,6,9, and 12 months to monitor the lesion through out the follow-up period. b)CBCT scan to measure quantitatively the volume and area of the periapical lesion after 12 months follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X3 group | Experimental | Other: Regenerative Endodontics Procedures (REPs) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Necrotic Mature Maxillary anterior teeth with periapical lesions.
Key exclusion criteria (1 listed)
- Patients with mobile and fractured teeth
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 |
|---|---|---|
| Regenerative Endodontics Procedures (REPs)REPs was done for 10 mature maxillary necrotic teeth with periapical lesions. Instrumentation was done using Protaper Next system till size X3. Irrigation with 1.5 % NaOCl was done in the first visit. in the second visit, bleeding was induced in the canal by irritating the periapical area followed by the application of Biodentine as cervical plug then completion of the coronal restoration. | Other | X3 group |
Primary outcome
Measurement the volume of periapical lesion preoperatively and comparing it with the new volume after REPs using cone-beam computed tomography.
Time frame: 12 months
Measuring the volume in mm3
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 30 Nov 2020.
- Derived from this study: PubMed 34826060Kateb NME, Fata MM. Influence of periapical lesion size on healing outcome following regenerative endodontic procedures: a clinical investigation. Oral Radiol. 2022 Oct;38(4):480-489. doi: 10.1007/s11282-021-00578-8. Epub 2021 Nov 26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Regenerative Endodontics Procedures (REPs) in people with Necrotic Pulp and Periapical; Infection, run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 1 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 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Measurement the volume of periapical lesion preoperatively and comparing it with the new volume after REPs using cone-beam computed tomography. (time frame: 12 months). 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 NCT04646538, 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 Nov 2020.