Asymptomatic Apical PeriodontitisNCT06973135
Non-Surgical Single Visit Endodontic Retreatment in Cases With Asymptomatic Apical Periodontitis Using Bioceramic Sealer
A study testing Bioceramic sealer root canal obturation and resin sealer root canal obturation in people with Asymptomatic Apical Periodontitis and Root Canal Retreatment, run by Saly Nazeer at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if using bioceramic sealers in non surgical single visit endodontic retreatment in patients with endodontic treatment failure and asymptomatic apical periodontitis will work in comparison to other resin sealer which proved efficacy ,and help healing of the periapical lesions… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Apical Periodontitis, Root Canal Retreatment
- What is being tested?
- Bioceramic sealer root canal obturation and resin sealer root canal obturation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mandibular molar teeth with previous unsuccessful endodontic treatment from ≥ 1 year with asymptomatic apical periodontitis.
- Teeth with inadequate obturation.
- Teeth with broken instruments that can be bypassed and/or retrieved and not present in the apical third or passing through the apex.
- Teeth with periapical lesion.
- Patient with the ages of 18-65 years.
- Patient medically healthy and free from systemic diseases or with mild controlled systemic disease. ASA I, II * (52).
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- Patient with no acute pain or extraoral swelling.
- Patients who agreed to participate in the study and attend the control visits.
- -
Who cannot join
- Teeth requiring retreatment with a poor prognosis (root canal morphology altered, large carious cavity, internal or external root resorption, root perforation)
- Teeth with vertical root fracture or open apex.
- Patient with systemic disorders related to bone metabolism and using drugs that may affect bone metabolism.
- Pregnant patients.
- Patient under antibiotics treatment 2 weeks before the treatment.
- Patients who could not attend follow up will be excluded from the study
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry Alexandria university
Alexandria, Alexandria Governorate, 0000
About this study
Official title: Outcome Of Non-Surgical Single Visit Endodontic Retreatment in Teeth With Asymptomatic Apical Periodontitis Using Bioceramic Sealer (A Randomized Controlled Clinical Trial)
The goal of this clinical trial is to learn if using bioceramic sealers in non surgical single visit endodontic retreatment in patients with endodontic treatment failure and asymptomatic apical periodontitis will work in comparison to other resin sealer which proved efficacy ,and help healing of the periapical lesions and reduce the anticipated postoperative pain , Participants will have root canal retreatment done in a single visit and then follow up will be done in 1, 3 and 6 months to check healing and then after 12 months , also postoperative pain will be monitored through communicating the patients after 24, 28 , 72 hours and the 7 days
Read the detailed description
selection of the cases will be done according to the eligibility criteria the a baseline periapical radiograph to record the periapical index and base line CBCT will be done to measure the lesion size and record the CBCTPAI then patients will be divided into two groups (A AND B) randomly to perform single visit non surgical root canal retreatment using bioceramic sealer in obturation in group A and resin sealer in group B then post operative pain assessment will be done using numerical scale after 24, 48, 72 hours and 7 days .for radiographical and clinical measuring of the healing follow up will done after 1, 3, 6 and 12 months by performing periapical radiographs and recording PAI and clinical signs or symptoms and CBCT after 12 months to record CBCTPAI and compare the size differences at baseline
- Being tested
- Bioceramic sealer root canal obturation, resin sealer root canal obturation
- Keywords
- CBCT, secondary root canal treatment, asymptomatic apical periodontitis, bioceramic sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioceramic sealer root canal obturationProcedure or surgery
Mandibular molars root canal obturation with bioceramic sealer after non surgical endodontic retreatment and then immediate periapical radiograph will be done to record PAI
resin sealer root canal obturationProcedure or surgery
non surgical root canal retreatment of mandibular molar teeth will be done using resin based sealer in obturation and periapical radiograph will be taken immediately to record PAI
| Study group | Role | What they receive |
|---|---|---|
| bioceramic sealer group | Active comparator | obturation of mandibular molar root canals using bioceramic sealer after canal shaping and cleaning in single visit Receives: Procedure: Bioceramic sealer root canal obturation |
| resin sealer group | Active comparator | mandibular molar root canal obturation using resin sealer after canal cleaning and shaping in single visit Receives: Procedure: resin sealer root canal obturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the healing of periapical lesions through comparing size of lesion using periapical radiograph and CBCT before and after 1 year follow up
periapical radiograph and cone beam computed tomography will be taken to measure the size of the lesion and record the PAI and CBCTPAI at baseline then root canal retreatment will be done in single visit using bioceramic sealer in obturation in group A and resin sealer in group B and then periapical radiograph will be taken after 1, 3, 6 , 12 months to record PAI and CBCT at 12 months to record CBCTPAI to evaluate healing through measuring the sizes of periapical lesions , together with clinical record of the patients symptoms after 1, 3 ,6 and 12 months
Measured: 21 months
Secondary outcomes (1)
Clinical assessment of post operative pain
The postoperative pain will be recorded using a numeric rating scale (NRS) on a 0-10 scale, with 0 indicating no pain and 10 indicating the worst pain. Patients were required to report their pain level at 4-time intervals after obturation: 24, 48, 72 hours and 7 days. The highest pain score recorded at 3 consecutive time points will be selected
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Jun 2025
- Primary completion28 Jan 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Apical PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saly Nazeer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Saly Nazeer, Alexandria University
- Investigators
- Sybel M Moussa, Phd, Study director, Alexandria UniversityNehal Lehita, Phd, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973135
- Sponsor's protocol ID
- 0966-09/2024
- Status last verified
- Aug 2026
- First submitted
- 4 May 2025
- Last updated
- 6 Aug 2026
- Results posted
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Of Non-Surgical Single Visit Endodontic Retreatment in Teeth With Asymptomatic Apical Periodontitis Using Bioceramic Sealer (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06973135
- Acronym / sponsor ID
- 0966-09/2024
- Keywords
- CBCT, secondary root canal treatment, asymptomatic apical periodontitis, bioceramic sealer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saly NazeerUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 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 learn if using bioceramic sealers in non surgical single visit endodontic retreatment in patients with endodontic treatment failure and asymptomatic apical periodontitis will work in comparison to other resin sealer which proved efficacy ,and help healing of the periapical lesions and reduce the anticipated postoperative pain , Participants will have root canal retreatment done in a single visit and then follow up will be done in 1, 3 and 6 months to check healing and then after 12 months , also postoperative pain will be monitored through communicating the patients after 24, 28 , 72 hours and the 7 days
Detailed description
selection of the cases will be done according to the eligibility criteria the a baseline periapical radiograph to record the periapical index and base line CBCT will be done to measure the lesion size and record the CBCTPAI then patients will be divided into two groups (A AND B) randomly to perform single visit non surgical root canal retreatment using bioceramic sealer in obturation in group A and resin sealer in group B then post operative pain assessment will be done using numerical scale after 24, 48, 72 hours and 7 days .for radiographical and clinical measuring of the healing follow up will done after 1, 3, 6 and 12 months by performing periapical radiographs and recording PAI and clinical signs or symptoms and CBCT after 12 months to record CBCTPAI and compare the size differences at baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bioceramic sealer group | Active comparator | Procedure: Bioceramic sealer root canal obturationobturation of mandibular molar root canals using bioceramic sealer after canal shaping and cleaning in single visit |
| resin sealer group | Active comparator | Procedure: resin sealer root canal obturationmandibular molar root canal obturation using resin sealer after canal cleaning and shaping in single visit |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Mandibular molar teeth with previous unsuccessful endodontic treatment from ≥ 1 year with asymptomatic apical periodontitis.
- Teeth with inadequate obturation.
- Teeth with broken instruments that can be bypassed and/or retrieved and not present in the apical third or passing through the apex.
- Teeth with periapical lesion.
- Patient with the ages of 18-65 years.
Key exclusion criteria (7 listed)
- Teeth requiring retreatment with a poor prognosis (root canal morphology altered, large carious cavity, internal or external root resorption, root perforation)
- Teeth with vertical root fracture or open apex.
- Patient with systemic disorders related to bone metabolism and using drugs that may affect bone metabolism.
- Pregnant patients.
- Patient under antibiotics treatment 2 weeks before 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 |
|---|---|---|
| Bioceramic sealer root canal obturationMandibular molars root canal obturation with bioceramic sealer after non surgical endodontic retreatment and then immediate periapical radiograph will be done to record PAI | Procedure or surgery | bioceramic sealer group |
| resin sealer root canal obturationnon surgical root canal retreatment of mandibular molar teeth will be done using resin based sealer in obturation and periapical radiograph will be taken immediately to record PAI | Procedure or surgery | resin sealer group |
Primary outcome
Measure the healing of periapical lesions through comparing size of lesion using periapical radiograph and CBCT before and after 1 year follow up
Time frame: 21 months
periapical radiograph and cone beam computed tomography will be taken to measure the size of the lesion and record the PAI and CBCTPAI at baseline then root canal retreatment will be done in single visit using bioceramic sealer in obturation in group A and resin sealer in group B and then periapical radiograph will be taken after 1, 3, 6 , 12 months to record PAI and CBCT at 12 months to record CBCTPAI to evaluate healing through measuring the sizes of periapical lesions , together with clinical record of the patients symptoms after 1, 3 ,6 and 12 months
1 secondary outcome
Clinical assessment of post operative pain
Time frame: 21 months
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 6 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sybel M Moussa, Phd study director
Alexandria University
Nehal Lehita, Phd study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioceramic sealer root canal obturation and resin sealer root canal obturation in people with Asymptomatic Apical Periodontitis and Root Canal Retreatment, run by Saly Nazeer 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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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?
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?
Measure the healing of periapical lesions through comparing size of lesion using periapical radiograph and CBCT before and after 1 year follow up (time frame: 21 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 6 Aug 2026.