Evaluation of the Efficacy of Growth Hormone on Healing of Periapical Pathosis

Al-Azhar University

Status: Active, not recruiting

Conditions: Non Surgical Debulking; Growth Hormone; Periapical Diseases

Treatments: Procedure: Non surgical debulking of periapical tissues; Procedure: Growth hormone application; Procedure: Root canal treatment; Procedure: Non surgical debulking of periapical tissues with growth hormone application

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 and non-surgical debulking of periapical tissues on healing of periapical pathosis

Full description

Out of ninety patients, forty-eight healthy male patients aged 18 to 40 years old were selected from outpatients attending the Endodontic Clinic of the Faculty of Dental Medicine, Al-Azhar University Boys, Cairo, Egypt, to be included in this study. The selected patients have no medical contraindications for oral surgical procedures (Scores1-2) according to the classification of the American Society of Anesthesiologists (ASA)(8). Maxillary permanent incisor teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients.

Enrollment: 48 estimated 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

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48 participants in 4 patient groups

Non surgical debulking group

Experimental group

Description:

Teeth undergo non-surgical debulking of periapical tissues.

Treatment:

Procedure: Non surgical debulking of periapical tissues with growth hormone application

Procedure: Non surgical debulking of periapical tissues

Growth hormone group

Experimental group

Description:

Teeth undergoes Growth Hormone application.

Treatment:

Procedure: Non surgical debulking of periapical tissues with growth hormone application

Procedure: Growth hormone application

Non surgical Debulking & Growth hormone group

Experimental group

Description:

Teeth undergo non-surgical debulking of periapical tissues with Growth Hormone application.

Treatment:

Procedure: Non surgical debulking of periapical tissues with growth hormone application

Control group

Experimental group

Description:

Teeth undergo conventional root canal treatment without any additional intervention

Treatment:

Procedure: Root canal treatment