Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06433375
Other study ID # 27/4/2023
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02625298 - Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth Phase 2
Recruiting NCT05888935 - Detection of Periapical Lesions on Dental Panoramic Radiographs Based on Artificial Intelligence
Completed NCT05555563 - Effect of MTAD on The Outcome of Primary Root Canal Treatment N/A
Active, not recruiting NCT05555043 - Comparison of Clinical Outcomes Between GentleWave® and Biolase® N/A
Enrolling by invitation NCT05714384 - Outcome of Calcium Silicate Sealer-based Obturation in Root Canal Retreatment
Not yet recruiting NCT05305417 - Cell-free Autologous Regenerative Endodontics Treatment for Teeth With Periapical Lesions (CARETT) N/A
Completed NCT03108183 - Apicoectomy Longterm Results N/A
Active, not recruiting NCT02196740 - Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis N/A
Completed NCT04315259 - Efficiency of Diode Laser in Control of Post-endodontic Pain N/A
Completed NCT04311879 - Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues N/A
Completed NCT04311905 - Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues N/A
Completed NCT06250114 - Retreat or Replace: Retrospective Investigation on a Cohort of Local Patients
Recruiting NCT06258798 - The Use of Artificial Intelligence in the Dental X-rays Analysis
Recruiting NCT06252337 - Survival and Success of Two Different Filling Techniques N/A
Active, not recruiting NCT05478811 - Evaluation of RANKL/OPG Levels in Gingival Crevicular Fluid at 1st and 3rd Months of Activation of NaOCl With Er,Cr YSSG Laser in Root Canal Treatment N/A
Completed NCT05863728 - Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study N/A
Completed NCT05943769 - The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial) N/A
Completed NCT04333940 - Impact of Periapical Radiography and Cone Beam Computed Tomography on Periapical Assessment Following Surgical Endodontic Treatment N/A
Completed NCT03227172 - Differential Diagnosis Between Granuloma and Radicular Cyst: Effectiveness of Magnetic Resonance Imaging. N/A
Completed NCT04348578 - Effect of QMix 2in1 as Final Irrigation Protocol on Periapical Healing N/A