Periapical Diseases Clinical Trial
Official title:
Evaluation of the Efficacy of Growth Hormone and Non-Surgical Debulking of Periapical Tissues on Healing of Periapical Pathosis
Verified date | May 2024 |
Source | Al-Azhar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed to evaluate the effect of growth hormone and non-surgical debulking of periapical tissues on healing of periapical pathosis
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Al Azhar University | Cairo | Nasr City |
Lead Sponsor | Collaborator |
---|---|
Al-Azhar University |
Egypt,
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 |
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