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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06433375
Enrollment
28
Registered
2024-05-29
Start date
2023-04-01
Completion date
2025-04-01
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EndoSeal MTA, Growth Hormone, Periapical Pathosis

Keywords

Periapical Pathosis, Growth Hormone, EndoSeal MTA

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREGrowth hormone application

Growth hormone application during non-surgical root canal treatment

PROCEDURERoot canal treatment

Teeth undergo conventional root canal treatment without any additional intervention

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Post operative CBCT scan6 monthsEvaluation of non surgical root canal tratment healing according to CBCTPAI

Secondary

MeasureTime frameDescription
Post operative pain assesment6 hoursThe 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026