Evaluation of the Efficacy of Growth Hormone, EndoSeal MTA Sealer, and Their Combination on Healing of Periapical Pathosis(Non-Surgical Approach)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Post operative CBCT scan
Study Overview
Brief Summary
This study aimed to evaluate the effect of growth hormone, EndoSeal MTA sealer, and their combination on Healing of Periapical Pathosis.
Detailed Description
Out of 100 healthy male patients aged 18 to 40 years, 32 were selected from outpatients attending the Endodontic Clinic of the Faculty of Dental Medicine, Al-Azhar University, Cairo, Egypt, to be included in this study. The selected patients have no medical contraindications for oral surgical procedures (Scores 1-2) according to the classification of the American Society of Anesthesiologists (ASA)(8). Single-rooted permanent teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Necrotic teeth with apical periodontitis.
- •Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility.
- •Teeth with mature apices, root canal curvature between (0-10º) according to Schneider(9) and radii of curvature between 2 to 5 mm according to Pruett would be included in the study(10).
- •Teeth with estimated working length of 20mm(±2mm) from the incisal edge as a reference point provided that the crown/root ratio was not compromised.
- •Non-critical sized periapical lesion related only to one tooth of a 2 to 4mm diameter and score 3 when evaluated using the Cone Beam Computed Tomography Periapical Index Score (CBCTPAI)(11) , Table (1) presents the scoring scale of CBCT-PAI.
- •Teeth located in anatomic areas in which enucleation of the periapical tissues may jeopardize nearby structures, such as the incisive foramen or nasal cavity should be at least 2 mm away from these structures.
Exclusion Criteria
- •Necrotic teeth with related periapical swelling or sinus tract.
- •Teeth with previous root canal fillings and /or indirect coronal restoration.
- •Teeth with abnormal root canal anatomy.
- •Non-restorable teeth due to insufficient coronal tooth structure.
- •Teeth with periodontal disease.
- •Teeth with grade III mobility.
- •Teeth with clinical evidence of a missing buccal bony plate over the periapical defect.
- •Traumatized teeth with suspected root cracks, fractures, intrusive and extrusive injuries, previously avulsed or lateral luxation injuries.
Arms & Interventions
Growth hormone group
Teeth undergo Growth Hormone application before obturation using EndoSeal MTA sealer
Intervention: Growth hormone application (Procedure)
Control group
Teeth undergo conventional root canal obturation using EndoSeal MTA sealer without any additional intervention
Intervention: Root canal treatment (Procedure)
Outcomes
Primary Outcomes
Post operative CBCT scan
Time Frame: 12 months
Evaluation of non surgical root canal tratment healing according to CBCTPAI
Post operative CBCT scan
Time Frame: 6 months
Evaluation of non surgical root canal tratment healing according to CBCTPAI
Secondary Outcomes
- Post operative pain assesment(1 week)
- Post operative pain assesment(6 hours)
- Post operative pain assesment(24 hours)
- Post operative pain assesment(48 hours)
- Post operative pain assesment(72 hours)
Investigators
Mohamed Zakaria Abd El Aziz
Principal investigator
Al-Azhar University