Root Perforation at the Bifurcation AreaPhase 4NCT06976411
Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
A Phase 4 study testing MTA and Bioceramic putty in people with Root Perforation at the Bifurcation Area, run by Mohamed Salah Elwakeel at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate healing potentiality of MTA and bioceramics materials as a root perforation repair material. The main questions it aims to answer are: is there is a significant difference in healing potentiality of MTA and bioceramics materials as a root perforation repair material?… Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Perforation at the Bifurcation Area
- What is being tested?
- MTA and Bioceramic putty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with root perforation in lower molars.
- Patients had anon contributory medical history.
- Patients of age categories between 15 to 50 years old.
- No sex restriction.
- Small to medium size perforation.
Who cannot join
- Patients with generalized chronic periodontitis.
- Teeth with difficult isolation.
- Non restorable teeth.
- Medically compromised patients.
- Patients with history of allergies to any of the medications to be used during or after the treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
The goal of this clinical trial is to evaluate healing potentiality of MTA and bioceramics materials as a root perforation repair material.
The main questions it aims to answer are:
is there is a significant difference in healing potentiality of MTA and bioceramics materials as a root perforation repair material?
Participants will:
enrollment will be from out-patients clinic of endodontic department, faculty of dentistry, Ain Shams university with root perforations. perforation repair will be done using either bio-ceramic or MTA repair material and preoperative or immediate postoperative CBCT and postoperative CBCT will be taken to compare healing.
- Conditions
- Root Perforation at the Bifurcation Area
- Being tested
- MTA, Bioceramic putty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTADrug
Perforation repair using MTA repair material
Bioceramic puttyDrug
Perforation repair using Bioceramic repair material
| Study group | Role | What they receive |
|---|---|---|
| MTA | Experimental | Not described Receives: Drug: MTA |
| Bioceramic | Experimental | Not described Receives: Drug: Bioceramic putty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic success in terms of healing
Healing outcome: the presence or absence of lesion and its size were obtained by analyzing CBCT of each case and classified into: Cases with complete resolution of lesion considered as "Healed", reduction of size considered as "Healing", and no size change or increase in lesion size considered as "Failure"
Measured: 1 year
patients with clinical success
A successful clinical outcome was defined as follows: no indication of apical periodontitis, no clinical signs and symptoms, and no loss of function.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Perforation at the Bifurcation AreaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Salah Elwakeel
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Mohamed Salah Elwakeel, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976411
- Sponsor's protocol ID
- FDASU-REC 1117 pro
- Status last verified
- Dec 2024
- First submitted
- 9 May 2025
- Last updated
- 22 May 2025
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
- ClinicalTrials.gov ID
- NCT06976411
- Acronym / sponsor ID
- FDASU-REC 1117 pro
- Conditions
- Root Perforation at the Bifurcation Area
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mohamed Salah ElwakeelUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 May 2025 (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 goal of this clinical trial is to evaluate healing potentiality of MTA and bioceramics materials as a root perforation repair material.
The main questions it aims to answer are:
is there is a significant difference in healing potentiality of MTA and bioceramics materials as a root perforation repair material?
Participants will:
enrollment will be from out-patients clinic of endodontic department, faculty of dentistry, Ain Shams university with root perforations. perforation repair will be done using either bio-ceramic or MTA repair material and preoperative or immediate postoperative CBCT and postoperative CBCT will be taken to compare healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA | Experimental | Drug: MTA |
| Bioceramic | Experimental | Drug: Bioceramic putty |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with root perforation in lower molars.
- Patients had anon contributory medical history.
- Patients of age categories between 15 to 50 years old.
- No sex restriction.
- Small to medium size perforation.
Key exclusion criteria (5 listed)
- Patients with generalized chronic periodontitis.
- Teeth with difficult isolation.
- Non restorable teeth.
- Medically compromised patients.
- Patients with history of allergies to any of the medications to be used during or after the 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 |
|---|---|---|
| MTAPerforation repair using MTA repair material | Drug | MTA |
| Bioceramic puttyPerforation repair using Bioceramic repair material | Drug | Bioceramic |
Primary outcome
Radiographic success in terms of healing
Time frame: 1 year
Healing outcome: the presence or absence of lesion and its size were obtained by analyzing CBCT of each case and classified into: Cases with complete resolution of lesion considered as "Healed", reduction of size considered as "Healing", and no size change or increase in lesion size considered as "Failure"
patients with clinical success
Time frame: 1 year
A successful clinical outcome was defined as follows: no indication of apical periodontitis, no clinical signs and symptoms, and no loss of function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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.
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 Phase 4 study testing MTA and Bioceramic putty in people with Root Perforation at the Bifurcation Area, run by Mohamed Salah Elwakeel 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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 22 May 2025. 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?
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?
This study is still under way. Results are not available in the source record yet.
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?
Radiographic success in terms of healing (time frame: 1 year). The study lists 2 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 22 May 2025.