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

Periapical Diseases Clinical Trial

Official title:

Evaluation of the Efficacy of Growth Hormone and Non-Surgical Debulking of Periapical Tissues on Healing of Periapical Pathosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06433375
• Other study ID #: 27/4/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Growth Hormone
• Periapical Diseases

Intervention

Procedure:
• Non surgical debulking of periapical tissues
Non surgical debulking of periapical tissues
• Growth hormone application
Growth hormone application during non-surgical root canal treatment
• Non surgical debulking of periapical tissues with growth hormone application
Non-surgical debulking of periapical tissues with growth hormone application during non-surgical root canal treatment
• Root canal treatment
Teeth undergo conventional root canal treatment without any additional intervention

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative CBCT scan	Evaluation of non surgical root canal tratment healing according to CBCTPAI	6 months
Primary	Post operative CBCT scan	Evaluation of non surgical root canal tratment healing according to CBCTPAI	12 months
Secondary	Post operative pain assesment	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).	24 hours
Secondary	Post operative pain assesment	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).	48 hours
Secondary	Post operative pain assesment	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).	72 hours
Secondary	Post operative pain assesment	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).	96 hours
Secondary	Post operative pain assesment	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).	120 hours