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This clinical study will be conducted to evaluate the effect of using intracanal Omega-3 Fatty acids during revascularization of necrotic immature teeth compared to the traditional induced bleeding technique.
Immature permanent teeth with pulp necrosis have thin, fragile dentinal walls, making conventional endodontic sealing techniques challenging. Regenerative endodontics (RE) offers a biologically based alternative that enables continued root development, apical closure, and potential restoration of vitality through approaches such as tissue engineering and revascularization. These procedures rely heavily on the survival and differentiation of stem cells from the apical papilla, even in the presence of infection.
Inflammation plays a pivotal role in RE, influencing both healing and regenerative outcomes. Specialized pro-resolving mediators (SPMs), derived from omega-3 and omega-6 fatty acids, actively resolve inflammation and promote tissue regeneration. Among them, Resolvin E1 (RvE1), derived from EPA, has shown potent anti-inflammatory and pro-regenerative effects, including inhibition of leukocyte infiltration and enhancement of dental pulp stem cell recruitment. Experimental studies demonstrated that intracanal RvE1 reduced periapical inflammation and promoted root development more effectively than traditional intracanal medicaments.
Omega-3 polyunsaturated fatty acids (ω-3 PUFAs), particularly EPA and DHA, have been widely studied in dentistry for their anti-inflammatory and regenerative properties. Evidence from animal studies and clinical trials indicates that ω-3 PUFAs reduce inflammatory mediators, suppress bone resorption, enhance new bone formation, and support stem cell proliferation and differentiation, even under inflammatory conditions. Clinically, ω-3 PUFAs have shown benefits in periodontal therapy, oral mucositis, and other inflammatory oral diseases.
Despite these promising findings, clinical evidence supporting the use of ω-3 PUFAs in endodontics remains limited. Further research is needed to evaluate their role in regenerative endodontic procedures, particularly in necrotic immature teeth where mechanical disinfection is restricted and preservation of apical stem cells is critical. The proposed hypothesis is that ω-3 PUFAs may enhance regenerative endodontic outcomes by modulating inflammation and supporting tissue regeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 ( Control ) : Traditional induced bleeding technique | Other | A sterile K-file will be inserted 2 mm beyond the canal terminus to induce bleeding and blood clots inside the canal. The canal orifice which is located in the cervical part of the root canal, measuring 2-3 mm, will be sealed using a white mineral trioxide aggregate (MTA) orifice plug. Then, the access cavity will be sealed using bulk-fill flow composite |
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| Group 2: Induced bleeding technique with application of Omega-3 Fatty Acids | Other | The procedure will be identical to that of the first group, except that the ω-3 PUFAs (prepared at the Department of Pharmacognosy, Faculty of Pharmacy, Mansoura University) will be delivered into the root canal during the revascularization procedure. The canal orifice will be sealed in the same manner as in the first group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega -3 fatty acids | Drug | used within the Regenerative procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Root Length | Radiographic increase in root length (Millimeters (mm)) | 12 months |
| Increase in Dentinal Wall Thickness | Radiographic increase in dentinal wall thickness measured using digital image analysis ( Millimeters (mm) ) | 12 months |
| Periapical Bone Formation | Radiographic evidence of periapical bone formation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | 111 | Egypt |
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D002126 | Calcium Hydroxide |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Calcium Hydroxide (Ca(OH)2) | Drug | Used as intracanal medicament |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |