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Completed

NCT Number: NCT06433375

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

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

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Key information

Conditions

Growth Hormone EndoSeal MTA Periapical Pathosis

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Al Azhar University

Cairo, Nasr City, 4450113, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Growth hormone application

Procedure

Growth hormone application during non-surgical root canal treatment

Root canal treatment

Procedure

Teeth undergo conventional root canal treatment without any additional intervention

Primary outcomes

  1. Post operative CBCT scan

    Time frame: 6 months

    Evaluation of non surgical root canal tratment healing according to CBCTPAI

  2. Post operative CBCT scan

    Time frame: 12 months

    Evaluation of non surgical root canal tratment healing according to CBCTPAI

Secondary outcomes

  1. Post operative pain assesment

    Time frame: 6 hours

    The postoperative pain assessment was done after obturation, 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).

  2. Post operative pain assesment

    Time frame: 24 hours

    The postoperative pain assessment was done after obturation, 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).

  3. Post operative pain assesment

    Time frame: 48 hours

    The postoperative pain assessment was done after obturation, 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).

  4. Post operative pain assesment

    Time frame: 72 hours

    The postoperative pain assessment was done after obturation, 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).

  5. Post operative pain assesment

    Time frame: 1 week

    The postoperative pain assessment was done after obturation, 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).

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of the Efficacy of Growth Hormone, EndoSeal MTA Sealer, and Their Combination on Healing of Periapical Pathosis(Non-Surgical Approach)

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 29, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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