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Outcomes of Conventional Root Canal Treatment Compared to Regenerative Endodontics, and Cleaning and Shaping Only in Mature Upper First Premolars

The Effect of Regenerative Endodontic Procedures and Only Cleaning and Shaping on The Outcome of Adult Mature Permanent Necrotic Teeth: A Randomized Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07609732
Enrollment
54
Registered
2026-05-27
Start date
2024-08-03
Completion date
2026-04-11
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleaning and Shaping Only With Proper Coronal Seal, Necrotic Mature First Premolar, Regenerative Endodontic Treatment

Keywords

Regenerative endodontic treatment, Regeneration in mature teeth, cleaning and shaping only concept

Brief 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

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

Interventions

OTHERcell homing

it is done by bleeding induction into the canals

PROCEDURECleaning and shaping only

proper canal disinfection and mechanical instrumentation followed by proper coronal seal

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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…

Design outcomes

Primary

MeasureTime frameDescription
Resolution of the clinical and radiographic sign and symptomsfollow ups 3, 6 12 monthsClinically, 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= ..%

Secondary

MeasureTime frameDescription
restoring of the pulp vitality which will be recorded by electric pulp tester3,6,12 monthsThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026