NCT07371416

Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids

Clinical Outcomes of Immature Teeth Treated With Regenerative Endodontic Procedures Using Intracanal Delivery of Omega-3 Fatty Acids

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 6 Years – 28 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Immature Permanent Teeth With Open Apex
• Pulp Necrosis

Interventions

Type	Name	Description
DRUG	Omega -3 fatty acids	used within the Regenerative procedures
DRUG	Calcium Hydroxide (Ca(OH)2)	Used as intracanal medicament

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: Egypt