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

NCT06433375 | Completed

• 1 other identifier: 27/4/2023
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Growth Hormone; EndoSeal MTA; Periapical Pathosis

Keywords

Periapical Pathosis; Growth Hormone; EndoSeal MTA

Outcome Measures

Primary Outcomes (2)

• Post operative CBCT scan

  Evaluation of non surgical root canal tratment healing according to CBCTPAI

  6 months

• Post operative CBCT scan

  Evaluation of non surgical root canal tratment healing according to CBCTPAI

  12 months

Secondary Outcomes (5)

• Post operative pain assesment

  6 hours

• Post operative pain assesment

  24 hours

• Post operative pain assesment

  48 hours

• Post operative pain assesment

  72 hours

• Post operative pain assesment

  1 week

Study Arms (2)

Growth hormone group

EXPERIMENTAL

Teeth undergo Growth Hormone application before obturation using EndoSeal MTA sealer

Procedure: Growth hormone application

Control group

EXPERIMENTAL

Teeth undergo conventional root canal obturation using EndoSeal MTA sealer without any additional intervention

Procedure: Root canal treatment

Interventions

Growth hormone application PROCEDURE

Growth hormone application during non-surgical root canal treatment

Growth hormone group

Root canal treatment PROCEDURE

Teeth undergo conventional root canal treatment without any additional intervention

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Nasr City, 4450113, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

EG (1)