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Evaluation of the Efficacy of Growth Hormone, EndoSeal MTA Sealer, and Their Combination on Healing of Periapical Pathosis

A

Al-Azhar University

Status

Completed

Conditions

EndoSeal MTA
Periapical Pathosis
Growth Hormone

Treatments

Procedure: Growth hormone application
Procedure: Root canal treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06433375
27/4/2023

Details and patient eligibility

About

This study aimed to evaluate the effect of growth hormone, EndoSeal MTA sealer, and their combination on Healing of Periapical Pathosis.

Full 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.

Enrollment

28 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 2 patient groups

Growth hormone group
Experimental group
Description:
Teeth undergo Growth Hormone application before obturation using EndoSeal MTA sealer
Treatment:
Procedure: Growth hormone application
Control group
Experimental group
Description:
Teeth undergo conventional root canal obturation using EndoSeal MTA sealer without any additional intervention
Treatment:
Procedure: Root canal treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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