Root Perforation at the Bifurcation AreaNCT06991569
Evaluation for Healing of Iatrogenic Perforation After Non Surgical Repair
An observational study of Root Perforation at the Bifurcation Area and Strip Perforation, run by Mohamed Salah Elwakeel at 1 site in Egypt.
Trial summary
The goal of this retrospective study is to evaluate the outcome of nonsurgical root perforation repair treated by specialized endodontist . The null hypothesis is: MTA can be used successfully as perforation repair material with high success rate subjects of the study were identified from patients who had received… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Root Perforation at the Bifurcation Area, Strip Perforation, Lateral Perforation
- What is being tested?
- Non-surgical perforation repair
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Aug 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: subjects were identified from among patients treated by endodontic specialist in his private clinic at Cairo, Egypt
Who may be able to join
- patients who had undergone nonsurgical endodontic perforation repair
Who cannot join
- Teeth that revealed root fracture, inadequate remaining tooth structure, or severe periodontitis
- Teeth that had undergone surgical perforation repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
The goal of this retrospective study is to evaluate the outcome of nonsurgical root perforation repair treated by specialized endodontist . The null hypothesis is:
MTA can be used successfully as perforation repair material with high success rate subjects of the study were identified from patients who had received endodontic treatment with non-surgical root perforation repair by an endodontic specialist in his private practice
- Being tested
- Non-surgical perforation repair
- Keywords
- Root canal perforation, Endodontics, MTA, Perforation repair material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical perforation repairProcedure or surgery
Root perforation repair using MTA or other perforation repair material
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: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jan 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
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
- NCT06991569
- Sponsor's protocol ID
- FDASU-REC 1117 Retrospective
- Status last verified
- Mar 2025
- First submitted
- 9 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
- ClinicalTrials.gov ID
- NCT06991569
- Acronym / sponsor ID
- FDASU-REC 1117 Retrospective
- Keywords
- Root canal perforation, Endodontics, MTA, Perforation repair material
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Mohamed Salah ElwakeelUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 28 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 retrospective study is to evaluate the outcome of nonsurgical root perforation repair treated by specialized endodontist . The null hypothesis is:
MTA can be used successfully as perforation repair material with high success rate subjects of the study were identified from patients who had received endodontic treatment with non-surgical root perforation repair by an endodontic specialist in his private practice
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects were identified from among patients treated by endodontic specialist in his private clinic at Cairo, Egypt
Key inclusion criteria (1 listed)
- patients who had undergone nonsurgical endodontic perforation repair
Key exclusion criteria (2 listed)
- Teeth that revealed root fracture, inadequate remaining tooth structure, or severe periodontitis
- Teeth that had undergone surgical perforation repair
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 |
|---|---|---|
| Non-surgical perforation repairRoot perforation repair using MTA or other perforation repair material | Procedure or surgery | – |
Primary outcome
Radiographic success in terms of Healing
Time frame: 7 years
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"
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 31 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Root Perforation at the Bifurcation Area
Enrolling by invitationPhase 4
Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
Root Perforation at the Bifurcation Area
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?
An observational study of Root Perforation at the Bifurcation Area and Strip Perforation, 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 1 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: finished, as of the sponsor's last update on 31 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.
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?
Radiographic success in terms of Healing (time frame: 7 years). 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 31 May 2025.