Endodontic Re-treatment FailureNCT07184151
Evaluation of Guided Endodontic Microsurgery and Two Different Retrograde Filling Materials
A study testing well root putty ( premixed bioceramic putty) retrograde filling and MTA retrograde filling in people with Endodontic Re-treatment Failure, run by Suez Canal University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the effect of guided endodontic microsurgical root end resection on bone healing compared to nonguided microsurgery using two different retrograde filling material (Well root putty, MTA) by cone-beam computed tomography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endodontic Re-treatment Failure
- What is being tested?
- well root putty ( premixed bioceramic putty) retrograde filling and MTA retrograde filling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2022to 15 Apr 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tooth is restorable pocket depth is less than 4mm and mobility in its normal limit ( less than 1mm)
- Persisting or emerging disease following root-canal treatment when root canal re-treatment is inappropriate.
- Tooth with acceptable endodontic treatment and have a new post and crown restoration, but have a persistent or enlarging periapical lesion ( size less than 10 mm)
- Obstructed canal (the obstruction proved not to be removable, by passed and the risk of damage was too great).
- Extruded material or instrument with clinical or radiological findings of apical periodontitis and/or symptoms are present.
Who cannot join
- Non restorable tooth
- Contraindicating medical condition ( severe systemic condition and psychological condition)
- Anatomical contra indication
- Poor general oral status and supporting periodontal tissue.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Guided Endodontic Microsurgery and Two Different Retrograde Filling Materials:A Randomized Clinical Trial
The aim of this study was to evaluate the effect of guided endodontic microsurgical root end resection on bone healing compared to nonguided microsurgery using two different retrograde filling material (Well root putty, MTA) by cone-beam computed tomography.
- Conditions
- Endodontic Re-treatment Failure
- Being tested
- well root putty ( premixed bioceramic putty) retrograde filling, MTA retrograde filling
- Keywords
- MTA, Well root putty, guided endodontic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
well root putty ( premixed bioceramic putty) retrograde fillingDrug
well root putty ( premixed bioceramic putty) retrograde filling
MTA retrograde fillingDrug
MTA retrograde filling
| Study group | Role | What they receive |
|---|---|---|
| microsurgical apicoectomy without guide+MTA | Active comparator | Not described Receives: Drug: MTA retrograde filling |
| microsurgical apicoectomy without guide+well root putty ( premixed bioceramic putty) retrograde fil | Experimental | Not described Receives: Drug: well root putty ( premixed bioceramic putty) retrograde filling |
| microsurgical apicoectomy with guide+MTA | Experimental | Not described Receives: Drug: MTA retrograde filling |
| microsurgical apicoectomy with guide+well root putty ( premixed bioceramic putty) retrograde fil | Experimental | Not described Receives: Drug: well root putty ( premixed bioceramic putty) retrograde filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating time
The operating time was measured from the beginning of osteotomy to the end of retrograde filling procedure
Measured: perioperative
Secondary outcomes (5)
Change in bone density measurement over time
Measured: 1 week, 6 months
Pain "Numerical Rating Scale (NRS)"
Pain was categorized into four categorical scores: (1) none [score 0], (2) mild [score from 1-3], (3) moderate [score from 4-6], (4) severe [score from 7-10
Measured: first day , 1 week
Change in Linear measurements over time
The evaluator located the slice on CBCT that will appear to demonstrate the largest size of the lesion and made a measurement of the lesion at what appeared to be the widest dimension. A second measurement of the widest dimension will be then made at 90 degrees to this initial measurement. These measurements will be made from a bone landmark to another bone landmark. These measurements will be performed in two planes for each lesion.
Measured: baseline and 6 months
Bone healing assessment
For analysis of periapical radiographic healing, CBCT scans were oriented in the buccolingual plane along the longitudinal axis of the treated roots. The observers rated the radiographic healing based on the parameters described recently by von Arx et al. (2016) in. Healing was categorized and scored as follows: 1. Fully healed (score 2) , Partially healed (score 1) and Not healed (score 0)
Measured: baseline and at 6 months
Change in volumetric measurement over time
Measured: 1 week, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start20 Jan 2022
- Primary completion12 Aug 2023
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic Re-treatment FailureStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed fouad el marakby, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184151
- Sponsor's protocol ID
- (REC) (379/ 2021)
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Guided Endodontic Microsurgery and Two Different Retrograde Filling Materials:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07184151
- Acronym / sponsor ID
- (REC) (379/ 2021)
- Conditions
- Endodontic Re-treatment Failure
- Keywords
- MTA, Well root putty, guided endodontic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 12 Aug 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 19 Sep 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 aim of this study was to evaluate the effect of guided endodontic microsurgical root end resection on bone healing compared to nonguided microsurgery using two different retrograde filling material (Well root putty, MTA) by cone-beam computed tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| microsurgical apicoectomy without guide+MTA | Active comparator | Drug: MTA retrograde filling |
| microsurgical apicoectomy without guide+well root putty ( premixed bioceramic putty) retrograde fil | Experimental | Drug: well root putty ( premixed bioceramic putty) retrograde filling |
| microsurgical apicoectomy with guide+MTA | Experimental | Drug: MTA retrograde filling |
| microsurgical apicoectomy with guide+well root putty ( premixed bioceramic putty) retrograde fil | Experimental | Drug: well root putty ( premixed bioceramic putty) retrograde filling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Tooth is restorable pocket depth is less than 4mm and mobility in its normal limit ( less than 1mm)
- Persisting or emerging disease following root-canal treatment when root canal re-treatment is inappropriate.
- Tooth with acceptable endodontic treatment and have a new post and crown restoration, but have a persistent or enlarging periapical lesion ( size less than 10 mm)
- Obstructed canal (the obstruction proved not to be removable, by passed and the risk of damage was too great).
- Extruded material or instrument with clinical or radiological findings of apical periodontitis and/or symptoms are present.
Key exclusion criteria (4 listed)
- Non restorable tooth
- Contraindicating medical condition ( severe systemic condition and psychological condition)
- Anatomical contra indication
- Poor general oral status and supporting periodontal tissue.
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 |
|---|---|---|
| well root putty ( premixed bioceramic putty) retrograde fillingwell root putty ( premixed bioceramic putty) retrograde filling | Drug | microsurgical apicoectomy with guide+well root putty ( premixed bioceramic putty) retrograde fil, microsurgical apicoectomy without guide+well root putty ( premixed bioceramic putty) retrograde fil |
| MTA retrograde fillingMTA retrograde filling | Drug | microsurgical apicoectomy with guide+MTA, microsurgical apicoectomy without guide+MTA |
Primary outcome
Operating time
Time frame: perioperative
The operating time was measured from the beginning of osteotomy to the end of retrograde filling procedure
5 secondary outcomes
Change in bone density measurement over time
Time frame: 1 week, 6 months
Pain "Numerical Rating Scale (NRS)"
Time frame: first day , 1 week
Change in Linear measurements over time
Time frame: baseline and 6 months
Bone healing assessment
Time frame: baseline and at 6 months
Change in volumetric measurement over time
Time frame: 1 week, 6 months
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 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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 study testing well root putty ( premixed bioceramic putty) retrograde filling and MTA retrograde filling in people with Endodontic Re-treatment Failure, run by Suez Canal 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 5 inclusion and 4 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 1 Oct 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?
Operating time (time frame: perioperative). 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 1 Oct 2025.