Regenerative Endodontics in Mature Permanent Teeth

Study Overview
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Brief Summary
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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

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

Conditions
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Regenerative Endodontics

Intervention / Treatment
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* Procedure: dental regenerative endodontics


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |