Regenerative Endodontic TreatmentNCT07609732
Outcomes of Conventional Root Canal Treatment Compared to Regenerative Endodontics, and Cleaning and Shaping Only in Mature Upper First Premolars
A study testing cell homing and Cleaning and shaping only in people with Regenerative Endodontic Treatment and Cleaning and Shaping Only With Proper Coronal Seal, run by Ain Shams University at 1 site in Egypt.
Trial summary
It was to compare clinically between the success of the primary endodontic treatment, regeneration, and only cleaning and shaping in necrotic mature first premolars with apical periodontitis Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Regenerative Endodontic Treatment, Cleaning and Shaping Only With Proper Coronal Seal, Necrotic Mature First Premolar
- What is being tested?
- cell homing and Cleaning and shaping only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2024to 11 Apr 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-50 years
- Medically free
- The patient should have the upper first premolar that needs endodontic treatment with apical periodontitis
- Necrotic teeth
- Participants were willing to commit to the entire period of the trial and agreed to sign the written consent after a full explanation of the study.
Who cannot join
- Symptomatic irreversible pulpitis
- If the premolar is non restorable
- If the premolar will need a post and core
- Vertical root fracture
- Open apex
- Presence of any systemic disease or allergic reactions.
- Vulnerable group; prisoners, pregnant females, mentally ill, etc…
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Regenerative Endodontic Procedures and Only Cleaning and Shaping on The Outcome of Adult Mature Permanent Necrotic Teeth: A Randomized Clinical Trial
It was to compare clinically between the success of the primary endodontic treatment, regeneration, and only cleaning and shaping in necrotic mature first premolars with apical periodontitis
Read the detailed description
a- Fifty four patients were enrolled and screened for eligibility b- Participants were randomly assigned to three groups (n=18 per group) i- Group [CRCT]: Conventional root canal treatment (n=18) ii- Group [REP] : Regenerative endodontic treatment (REP) (n=18), cell homing technique was used , and MTA was placed 3mm into the canals , the access was sealed by light cured glass ionomer then composite iii- Group [C.S]: Only cleaning and shaping (n=18) the same steps of REP but without bleeding induction and MTA was placed 3mm into the canals , the access was sealed by light cured glass ionomer then composite
- Conditions
- Regenerative Endodontic Treatment, Cleaning and Shaping Only With Proper Coronal Seal, Necrotic Mature First Premolar
- Being tested
- cell homing, Cleaning and shaping only
- Keywords
- Regenerative endodontic treatment, Regeneration in mature teeth, cleaning and shaping only concept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell homingOther
it is done by bleeding induction into the canals
Cleaning and shaping onlyProcedure or surgery
proper canal disinfection and mechanical instrumentation followed by proper coronal seal
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | conventional endodontic treatment, the canals were filled by conventional gutta percha with proper coronal seal |
| Regeneration group | Active comparator | Cell homing via bleeding induction was done, MTA was applied into the canals at a depth of 3mm, and the access was sealed by light-cured glass ionomer, then composite restorations were placed Receives: Other: cell homing |
| Cleaning and shaping only group | Experimental | Aseptic techniques were used while using the irrigation activation technique to enhance the irrigation effects, after then MTA was applied into the canals at a depth of 3mm, and the access was sealed by light-cured glass ionomer then composite restorations were placed to ensure proper coronal seal Receives: Procedure: Cleaning and shaping only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of the clinical and radiographic sign and symptoms
Clinically, no pain upon percussion or palpation, and no sinus tracts. Signs of radiographic bone healing it is going to be recorded as a yes/ no answer. No sign and symptoms= no pain upon percussion, palpation, and no sinus tract was observed Yes, there are signs and symptoms= that one or more of these criteria will be present [ pain upon percussion, presence of a bulge upon palpation, sinus tract exists] Radiographic healing will be assessed by 2 ways.
- Qualitative test by using the Periapical Index Score; score 1 indicates bone healing, and score 5 indicates Severe apical periodontitis, with exacerbating features
- Quantitative assessment measured the percent of lesion reduction using ImageJ software to measure the area of the lesion preoperatively and at follow-ups. This rule will be used: [preoperative area - postoperative area] / preoperative area = ... X100= ..%
Measured: follow ups 3, 6 12 months
Secondary outcomes (1)
restoring of the pulp vitality which will be recorded by electric pulp tester
The reading at each follow-up will be a yes/ no answer Yes, there is sensation if the patient feels tingling while using the electric pulp tester No, no sensation if the patient didn't feel the tingling
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start3 Aug 2024
- Primary completion7 Apr 2026
- Study completion11 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative Endodontic TreatmentStudies 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
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Reda Afifi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609732
- Sponsor's protocol ID
- 28/2/1993
- Status last verified
- Aug 2026
- First submitted
- 13 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regenerative Endodontic Procedures and Only Cleaning and Shaping on The Outcome of Adult Mature Permanent Necrotic Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07609732
- Acronym / sponsor ID
- 28/2/1993
- Conditions
- Regenerative Endodontic Treatment, Cleaning and Shaping Only With Proper Coronal Seal, Necrotic Mature First Premolar
- Keywords
- Regenerative endodontic treatment, Regeneration in mature teeth, cleaning and shaping only concept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 11 Apr 2026 (actual)
- First posted
- 27 May 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.
It was to compare clinically between the success of the primary endodontic treatment, regeneration, and only cleaning and shaping in necrotic mature first premolars with apical periodontitis
Detailed description
a- Fifty four patients were enrolled and screened for eligibility b- Participants were randomly assigned to three groups (n=18 per group) i- Group [CRCT]: Conventional root canal treatment (n=18) ii- Group [REP] : Regenerative endodontic treatment (REP) (n=18), cell homing technique was used , and MTA was placed 3mm into the canals , the access was sealed by light cured glass ionomer then composite iii- Group [C.S]: Only cleaning and shaping (n=18) the same steps of REP but without bleeding induction and MTA was placed 3mm into the canals , the access was sealed by light cured glass ionomer then composite
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –conventional endodontic treatment, the canals were filled by conventional gutta percha with proper coronal seal |
| Regeneration group | Active comparator | Other: cell homingCell homing via bleeding induction was done, MTA was applied into the canals at a depth of 3mm, and the access was sealed by light-cured glass ionomer, then composite restorations were placed |
| Cleaning and shaping only group | Experimental | Procedure: Cleaning and shaping onlyAseptic techniques were used while using the irrigation activation technique to enhance the irrigation effects, after then MTA was applied into the canals at a depth of 3mm, and the access was sealed by light-cured glass ionomer then composite restorations were placed to ensure proper coronal seal |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 20-50 years
- Medically free
- The patient should have the upper first premolar that needs endodontic treatment with apical periodontitis
- Necrotic teeth
- Participants were willing to commit to the entire period of the trial and agreed to sign the written consent after a full explanation of the study.
Key exclusion criteria (7 listed)
- Symptomatic irreversible pulpitis
- If the premolar is non restorable
- If the premolar will need a post and core
- Vertical root fracture
- Open apex
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 |
|---|---|---|
| cell homingit is done by bleeding induction into the canals | Other | Regeneration group |
| Cleaning and shaping onlyproper canal disinfection and mechanical instrumentation followed by proper coronal seal | Procedure or surgery | Cleaning and shaping only group |
Primary outcome
Resolution of the clinical and radiographic sign and symptoms
Time frame: follow ups 3, 6 12 months
Clinically, no pain upon percussion or palpation, and no sinus tracts. Signs of radiographic bone healing it is going to be recorded as a yes/ no answer. No sign and symptoms= no pain upon percussion, palpation, and no sinus tract was observed Yes, there are signs and symptoms= that one or more of these criteria will be present [ pain upon percussion, presence of a bulge upon palpation, sinus tract exists] Radiographic healing will be assessed by 2 ways. 1. Qualitative test by using the Periapical Index Score; score 1 indicates bone healing, and score 5 indicates Severe apical periodontitis, with exacerbating features 2. Quantitative assessment measured the percent of lesion reduction using ImageJ software to measure the area of the lesion preoperatively and at follow-ups. This rule will be used: [preoperative area - postoperative area] / preoperative area = ... X100= ..%
1 secondary outcome
restoring of the pulp vitality which will be recorded by electric pulp tester
Time frame: 3,6,12 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 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Regenerative Endodontic Treatment
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Not yet recruitingObservational study
The Effect of Using Different Scaffolds in Retreated Teeth on The Clinical and Radiological Success of Regenerative Endodontic Treatment
Endodontics, Regenerative Endodontic Procedures
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Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment
Apical Periodontitis, Periapical Diseases
Active, not recruiting
Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
Immature Permanent Teeth With Open Apex, Pulp Necrosis
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 cell homing and Cleaning and shaping only in people with Regenerative Endodontic Treatment and Cleaning and Shaping Only With Proper Coronal Seal, 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 5 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 21 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?
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 the clinical and radiographic sign and symptoms (time frame: follow ups 3, 6 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 21 Aug 2026.