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Completed

NCT Number: NCT05892536

Regenerative Endodontics in Mature Permanent Teeth

this study was designed to compare the clinical and radiographic success of REPs after using blood clot scaffold in non-vital mature permanent teeth with or without photobiomodultion therapy

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Key information

Conditions

Regenerative Endodontics

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients free from any systemic diseases or genetic disorders.
  • Children aged 9-13 years old of both sexes.
  • Traumatically or cariously exposed single rooted mature permanent teeth which may be asymptomatic or manifested with dull ache pain, or spontaneous unprovoked toothache.
  • Non-vital single rooted mature permanent teeth that indicated for endodontic treatment
  • Swelling close to involved tooth accompanied with or without fistula.
  • Negative response to cold & electrical pulp test.
  • Informed Consent.

Exclusion criteria

  • Unrestorable teeth, or that need post and core for the final restoration.
  • Immature permanent teeth.
  • Known allergy, sensitivity to ciprofloxacin, metronidazol.
  • Uncooperativeness of child and/or parents or caregiver's behavior.
  • Presence of calcific metamorphosis inside root canals.

Treatment and study plan

dental regenerative endodontics

Procedure

regenerative procedures performed in necrotic mature permanent teeth

Primary outcomes

  1. Pulp sensibility

    Time frame: Every 3 months over a period of one year

    clinical evaluation of pulp sensibility using electric pulp tester as a measurement tool

  2. Radiographic evaluation of periapical tissues

    Time frame: Every 3 months over a period of one year

    Radiographic evaluation using standardized digital radiograph that stored in computer for assessment of periapical tissues status using scoring system:

    • Score 0 - No radiological changes seen compared to preoperative radiograph
    • Score 1 - Slight decrease in radiolucency seen in periapical region
    • Score 2 - Complete reduction or resolution of radiolucency seen in periapical region.

Sponsors and collaborators

Lead sponsor

Salma fathy

Other

Registry information

Official study title

Evaluation of the Effect of Photobiomodulation on Revascularization of Mature Non-vital Permanent Teeth Using Blood Clot as Scaffold

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2023
Registry last updated
Jun 7, 2023

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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