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Completed

NCT Number: NCT07609732

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

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

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Of Dentistry Ain Shams University

Cairo, Cairo Governorate, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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…

Treatment and study plan

cell homing

Other

it is done by bleeding induction into the canals

Cleaning and shaping only

Procedure

proper canal disinfection and mechanical instrumentation followed by proper coronal seal

Primary outcomes

  1. 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.

    • 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= ..%

Secondary outcomes

  1. restoring of the pulp vitality which will be recorded by electric pulp tester

    Time frame: 3,6,12 months

    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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 27, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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