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

Not Applicable

Active, not recruiting

• Conditions: Periapical Diseases; Growth Hormone; Non Surgical Debulking
• Interventions: 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

• Registration Number: NCT06433375
• Lead Sponsor: Al-Azhar University

Brief Summary

This study aimed to evaluate the effect of growth hormone and non-surgical debulking of periapical tissues on healing of periapical pathosis

Detailed 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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-04-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-29
• Last Update Posted: 2024-05-29
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non surgical debulking group	Non surgical debulking of periapical tissues	Teeth undergo non-surgical debulking of periapical tissues.
Growth hormone group	Growth hormone application	Teeth undergoes Growth Hormone application.
Non surgical debulking group	Non surgical debulking of periapical tissues with growth hormone application	Teeth undergo non-surgical debulking of periapical tissues.
Growth hormone group	Non surgical debulking of periapical tissues with growth hormone application	Teeth undergoes Growth Hormone application.
Non surgical Debulking & Growth hormone group	Non surgical debulking of periapical tissues with growth hormone application	Teeth undergo non-surgical debulking of periapical tissues with Growth Hormone application.
Control group	Root canal treatment	Teeth undergo conventional root canal treatment without any additional intervention

Primary Outcome Measures

Name	Time	Method
Post operative CBCT scan	12 months	Evaluation of non surgical root canal tratment healing according to CBCTPAI

Secondary Outcome Measures

Name	Time	Method
Post operative pain assesment	120 hours	The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Nasr City, Egypt