Clinical trial NCT06433375: Evaluation of the Efficacy of Growth Hormone on Healing of Periapical Pathosis
Official title: Evaluation of the Efficacy of Growth Hormone and Non-Surgical Debulking of Periapical Tissues on Healing of Periapical Pathosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periapical Diseases
Growth Hormone
Non Surgical Debulking
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post operative CBCT scan
timeFrame: 6 months
measure: Post operative CBCT scan
timeFrame: 12 months
Secondary outcomes:
measure: Post operative pain assesment
timeFrame: 24 hours
measure: Post operative pain assesment
timeFrame: 48 hours
measure: Post operative pain assesment
timeFrame: 72 hours
measure: Post operative pain assesment
timeFrame: 96 hours
measure: Post operative pain assesment
timeFrame: 120 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
state: Nasr City
Study officials:
References: