Regenerative Endodontic ProceduresNCT07679152
Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals
A study testing Regenerative Endodontics procedures, Cleaning and Shaping Only and coronal seal and Conventional root canal treatment in people with Regenerative Endodontic Procedures and Irreversible Pulpitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statement of problem: Limitations and drawbacks associated with root canal obturation have the potential to impair periapical healing especially in the absence or delay of a proper coronal seal. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Regenerative Endodontic Procedures, Irreversible Pulpitis
- What is being tested?
- Regenerative Endodontics procedures, Cleaning and Shaping Only and coronal seal and Conventional root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2024to 20 May 2026
- 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 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males.
- Age: 18-50 years.
- Medically free.
- Vital, mature upper first premolars with irreversible pulpitis.
- Adequate coronal tooth structure.
- Compliant patients.
Who cannot join
- Generalized periodontitis.
- Females.
- Vertical root fracture.
- Immature teeth.
- Necrotic teeth.
- Systemic diseases that affect healing process.
- Non restorable teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals in Permanent Mature Vital Teeth
Statement of problem: Limitations and drawbacks associated with root canal obturation have the potential to impair periapical healing especially in the absence or delay of a proper coronal seal.
Aim of the study: Evaluate the endodontic treatment success in terms of resolution of signs and symptoms and periapical status using conventional periapical radiographs following two different treatment modalities, Coronally Sealed Non-obturated Canals, Regeneration-based Non-obturated Canals and comparing them to a control group of gutta percha obturated canals.
Materials and methods: Forty-eight Patients with mature, double canal, vital upper first premolars with irreversible pulpitis. In a single visit, the tooth is to be anesthetized, isolated and an access cavity is to be performed. Mechanical preparation of root canals is to be performed using the standardized technique reaching apical canal preparation to size #35 with taper of 4%. The patients will then be divided into three groups (n=16). Group One (Control group) will be conventionally obturated with gutta percha and resin sealer, and coronally sealed with glass ionomer and composite restoration. Group Two will be left unobturated and will receive a seal of MTA 2-3 mm below the CEJ then coronal restoration of glass ionomer and composite restoration. In Group Three, an induction of bleeding will be performed by apical violation and the tooth will receive a seal of MTA 2-3 mm below the CEJ then coronal seal of glass ionomer and composite restoration.
- Being tested
- Regenerative Endodontics procedures, Cleaning and Shaping Only and coronal seal, Conventional root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontics proceduresProcedure or surgery
The canals were be dried with paper points, and intentional over-instrumentation past the apical foramen into the periapical tissues was performed to induce bleeding inside the canal, to provide the blood clot that will act as a scaffold into which locally residing stem cells can get seeded and the cascade of healing process can initiate.
Cleaning and Shaping Only and coronal sealProcedure or surgery
The canals were dried with paper points, left unobturated and received MTA coronal plug 2-3 mm below CEJ then sealed coronally with Glass ionomer filling and composite restoration.
Conventional root canal treatmentProcedure or surgery
The canals were dried with paper points, obturated using gutta percha and resin sealer utilizing the warm vertical compaction obturation technique. The backfilling of the canal stopped at 3mm below canal orifice. Followed by an MTA coronal plus and glass ionomer and composite restoration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional root canal treatment | Active comparator | Not described Receives: Procedure: Conventional root canal treatment |
| Regeneration group | Active comparator | Not described Receives: Procedure: Regenerative Endodontics procedures |
| Cleaning and Shaping only | Active comparator | Not described Receives: Procedure: Cleaning and Shaping Only and coronal seal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of signs and symptoms. (Clinical Assessment) (VAS)(Visual Analogue Scale) No pain on percussion or palpation, absence of swellings and sinus tracts.
Measured: 12 months
Secondary outcomes (1)
Absence of periapical pathosis. (Periapical status in a conventional 2D periapical radiograph) (Periapical index PAI)
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 posted1 Jul 2026
- Study start8 Oct 2024
- Primary completion14 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative Endodontic ProceduresStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679152
- Sponsor's protocol ID
- FDASU-RECM012384
- Status last verified
- Feb 2023
- First submitted
- 17 Jun 2026
- Last updated
- 1 Jul 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals in Permanent Mature Vital Teeth
- ClinicalTrials.gov ID
- NCT07679152
- Acronym / sponsor ID
- FDASU-RECM012384
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 1 Jul 2026 (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.
Statement of problem: Limitations and drawbacks associated with root canal obturation have the potential to impair periapical healing especially in the absence or delay of a proper coronal seal.
Aim of the study: Evaluate the endodontic treatment success in terms of resolution of signs and symptoms and periapical status using conventional periapical radiographs following two different treatment modalities, Coronally Sealed Non-obturated Canals, Regeneration-based Non-obturated Canals and comparing them to a control group of gutta percha obturated canals.
Materials and methods: Forty-eight Patients with mature, double canal, vital upper first premolars with irreversible pulpitis. In a single visit, the tooth is to be anesthetized, isolated and an access cavity is to be performed. Mechanical preparation of root canals is to be performed using the standardized technique reaching apical canal preparation to size #35 with taper of 4%. The patients will then be divided into three groups (n=16). Group One (Control group) will be conventionally obturated with gutta percha and resin sealer, and coronally sealed with glass ionomer and composite restoration. Group Two will be left unobturated and will receive a seal of MTA 2-3 mm below the CEJ then coronal restoration of glass ionomer and composite restoration. In Group Three, an induction of bleeding will be performed by apical violation and the tooth will receive a seal of MTA 2-3 mm below the CEJ then coronal seal of glass ionomer and composite restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional root canal treatment | Active comparator | Procedure: Conventional root canal treatment |
| Regeneration group | Active comparator | Procedure: Regenerative Endodontics procedures |
| Cleaning and Shaping only | Active comparator | Procedure: Cleaning and Shaping Only and coronal seal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males.
- Age: 18-50 years.
- Medically free.
- Vital, mature upper first premolars with irreversible pulpitis.
- Adequate coronal tooth structure.
Key exclusion criteria (7 listed)
- Generalized periodontitis.
- Females.
- Vertical root fracture.
- Immature teeth.
- Necrotic 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 proceduresThe canals were be dried with paper points, and intentional over-instrumentation past the apical foramen into the periapical tissues was performed to induce bleeding inside the canal, to provide the blood clot that will act as a scaffold into which locally residing stem cells can get seeded and the cascade of healing process can initiate. | Procedure or surgery | Regeneration group |
| Cleaning and Shaping Only and coronal sealThe canals were dried with paper points, left unobturated and received MTA coronal plug 2-3 mm below CEJ then sealed coronally with Glass ionomer filling and composite restoration. | Procedure or surgery | Cleaning and Shaping only |
| Conventional root canal treatmentThe canals were dried with paper points, obturated using gutta percha and resin sealer utilizing the warm vertical compaction obturation technique. The backfilling of the canal stopped at 3mm below canal orifice. Followed by an MTA coronal plus and glass ionomer and composite restoration. | Procedure or surgery | Conventional root canal treatment |
Primary outcome
Resolution of signs and symptoms. (Clinical Assessment) (VAS)(Visual Analogue Scale) No pain on percussion or palpation, absence of swellings and sinus tracts.
Time frame: 12 months
1 secondary outcome
Absence of periapical pathosis. (Periapical status in a conventional 2D periapical radiograph) (Periapical index PAI)
Time frame: 12 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 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Regenerative Endodontic Procedures
Not yet recruitingObservational study
The Effect of Using Different Scaffolds in Retreated Teeth on The Clinical and Radiological Success of Regenerative Endodontic Treatment
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Active, not recruiting
Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
Immature Permanent Teeth With Open Apex, Pulp Necrosis
Enrolling by invitation
Maximum Occlusal Bite Force of Necrotic Permanent Teeth Treated by Regenerative Technique: Randomized Clinical Trial
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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 study testing Regenerative Endodontics procedures, Cleaning and Shaping Only and coronal seal and Conventional root canal treatment in people with Regenerative Endodontic Procedures and Irreversible Pulpitis, run by Ain Shams 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 6 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: finished, as of the sponsor's last update on 1 Jul 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?
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?
Resolution of signs and symptoms. (Clinical Assessment) (VAS)(Visual Analogue Scale) No pain on percussion or palpation, absence of swellings and sinus tracts. (time frame: 12 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 1 Jul 2026.