None listed
Conditions
Brief summary
Modern bio-compatible materials which used after cleaning, disinfecting and bleeding of the mature roots can obtain predictable results, and this study is intended to compare the success of Regenerative endodontic procedures REPs on non vital mature teeth (which contains absence of signs and symptoms in addition to periapical healing, while the positive response to vitality is favorable but not imperative requirement), using Biphasic Calcium Phosphate (BCP) scaffold / blood clot scaffold and Bioceramic root repair material (BC-RRM) / Mineral Trioxide Aggregate (MTA) as coronal sealing material.
Interventions
A clinical study will conduct on a sample of 40 adult patients in each patient with a non vital mature tooth. The sample will divide into 4 subgroups (10 in each group):
Biphasic Calcium Phosphate (BCP) scaffold and Bioceramic RRM, arm 1
Biphasic Calcium Phosphate (BCP) scaffold and MTA, arm 2
Blood clot scaffold and Bioceramic RRM, arm 3
Blood clot scaffold and MTA, arm 4
The canals will be prepared and the apical foramen will be enlarged to 0.60 mm, after that: Double Antimicrobial Paste (DAP)
A clinical study will conduct on a sample of 40 adult patients in each patient with a non vital mature tooth. The sample will divide into 4 subgroups (10 in each group): Biphasic Calcium Phosphate (BCP) scaffold and Bioceramic RRM, arm 1 Biphasic Calcium Phosphate (BCP) scaffold and MTA, arm 2 Blood clot scaffold and Bioceramic RRM, arm 3 Blood clot scaffold and MTA, arm 4 The canals will be prepared and the apical foramen will be enlarged to 0.60 mm, after that: Double Antimicrobial Paste (DAP) will be applied for a period of 3 weeks then it will be removed, then the induction of bleeding by bypassing the apex will be confirmed using 15 k-file and waiting for blood clot formation in the half of the sample while Biphasic Calcium Phosphate (BCP) scaffold will be applied in other half of the sample with two types of coronal sealing materials (Bioceramic root repair material BC RRM & Mineral Trioxide Aggregate MTA) will be used with both scaffolds. Participants will be informed of the need to have a dental check-up periodically, and if any adverse event is observed, they will proceed to Plan B (conventional Root Canal Treatment RCT), with periodic reminder by short message service. The application of all topical agents will be done by an experienced investigator and the intervention will be delivered at the clinics of the College of Dentistry. Neutral investigators (Practitioners who don't know the applied materials) will monitor the cases clinically and radiologically during additional 5 successive visits prolong on periods 3-6-9-12-15 months; (each visit will last about 15 minutes, after two primary visits of about one hour each) and the results will be compared, where the absence of symptoms and clinical signs and the periapical healing will be considered as the main criterion of success.
Sponsors
Damascus University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
-Non-vital pulp teeth caused by trauma, penetrating caries, or improper medical interventions. -Single-canal teeth (single-canal anterior teeth and single-canal premolars). -Periapical lesion is classified from 3 to 5 according to a scale (Orstavik, 1996).
Exclusion criteria
-Lesions exceeding the size of a 5 mm. -Significant expansion of the ligamentous distance with intense movement. -The possibility of radical cysts. -Anomalies. -Curvature. -Absorption.
Outcome results
None listed