Regenerative Endodontics in Mature Permanent Teeth

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

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

Study Overview

• Status: Completed
• Conditions: Regenerative Endodontics
• Intervention / Treatment: Procedure: dental regenerative endodontics

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: blood clot regeneration; 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; regenerative procedures performed in necrotic mature permanent teeth
Active Comparator: photo-biomodulation regeneration; 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; regenerative procedures performed in necrotic mature permanent teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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.	Every 3 months over a period of one year

Collaborators and Investigators

• Sponsor: Salma fathy
• Investigators: Principal Investigator: salma khattab, master, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No