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| Name | Class |
|---|---|
| Alexandria University | OTHER |
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this clinical trial is evaluating the outcome of laser assisted pulpotomy compared to conventional pulpotomy in mature teeth with symptomatic irreversible pulpitis (SIP) assessed by CBCT followed by automated segmentation using Artificial intelligence (AI).
Sixty human permanent molar teeth having irreversible pulpitis will be selected. Teeth will be randomly divided into 3 groups according to the type of pulpotomy; Group A: Photobiomodulation (PBM) pulpotomy, Group B: photocoagulation pulpotomy and Group C: Conventional pulpotomy which will serve as control. All 3 groups will be capped with bioceramic putty material. Post operative pain will be assessed at 24, 48 and 72 hours then after one week using numerical rating scale (NRS). Clinical and radiographic assessment using periapical radiograph of the healing progress will be done simultaneously during the follow up at one, three, six and 12 months intervals. CBCT will be done immediate postoperative and at the end of the follow up period to assess the dentin bridge formation and for automated segmentation to assess the radicular pulp volume changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Photo-biomodulation pulpotomy with Bioceramic putty | Experimental |
| |
| Group B photocoagulation pulpotomy with Bioceramic putty | Experimental |
| |
| Group C(Control) Conventional pulpotomy with Bioceramic putty | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diode laser | Device | a contact-type laser, it selectively and precisely affects only the tissues directly beneath it, thereby preserving the surrounding radicular tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of healing progress | evaluating clinically the signs and symptoms of pain and it will be recorded as yes and no question. - | one year |
| Radiographic assessment of the dentin bridge formation | evaluating the dentin bridge formation using periapical radiographs and CBCT | one year |
| Automated segmentation of the radicular pulp space | this will be done using CBCT imaging | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rana Mahmoud Hegazi, Assistant lecturer | Contact | 01094428209 | ranahegazi1991@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rania Noaman ELbackly, Professor | Endodontics, Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Recruiting | Alexandria | 21527 | Egypt |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Sodium Hypochlorite Solution | Other | A disinfecting agent used in conventional pulpotomy procedures |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006997 |
| Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |