Regenerative Endodontics in Mature Permanent Teeth

NCT05892536 | Completed

• 1 other identifier: 364
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Regenerative Endodontics

Outcome Measures

Primary Outcomes (2)

• Pulp sensibility

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

  Every 3 months over a period of one year

• Radiographic evaluation of periapical tissues

  Radiographic evaluation using standardized digital radiograph that stored in computer for assessment of periapical tissues status using scoring system: 1. Score 0 - No radiological changes seen compared to preoperative radiograph 2. Score 1 - Slight decrease in radiolucency seen in periapical region 3. Score 2 - Complete reduction or resolution of radiolucency seen in periapical region.

  Every 3 months over a period of one year

Study Arms (2)

blood clot regeneration

EXPERIMENTAL

the regenerative procedures were performed by over-instrumentation the apices and irritating the apical tissues to induce bleeding into the root canal, then orifices plugged with MTA over blood clot and restored with GI.

Procedure: dental regenerative endodontics

photo-biomodulation regeneration

ACTIVE COMPARATOR

photobiomodulation therapy was carried out using diode laser with wavelenght 810 nm and output power 300 mW on the apical root areas of buccal and lingual surfaces at 48 hours intervals for 2 weeks after completion of the regenerative procedures which were performed by over-instrumentation the apices and irritating the apical tissues to induce bleeding into the root canal, then orifices plugged with MTA over blood clot and restored with GI.

Procedure: dental regenerative endodontics

Interventions

dental regenerative endodontics PROCEDURE

regenerative procedures performed in necrotic mature permanent teeth

blood clot regeneration; photo-biomodulation regeneration

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salma fathy: lead

Study Sites (1)

Minia University

Minya, Egypt

Location

Study Officials

• salma khattab, master

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of pedodontics

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: June 7, 2023
• Study Start: January 5, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: June 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)