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

Mansoura University

Status: Active, not recruiting

Conditions: Immature Permanent Teeth With Open Apex; Pulp Necrosis

Treatments: Drug: Calcium Hydroxide (Ca(OH)2); Drug: Omega -3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT07371416

MDP.25.04.8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 28 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged between 6 and 28 years.
• Systemically healthy patients with no history of systemic diseases.
• Patients with necrotic immature permanent teeth due to trauma and/or caries.
• Preoperative radiographic evidence of incomplete root formation.
• Wide apical foramen (apical diameter ≥ 1 mm).
• Thin dentinal walls on preoperative radiographs.

Exclusion criteria

• Patients with known allergy to any of the drugs used in the study.
• Patients with systemic diseases or medically compromised conditions.
• Grossly decayed or fractured teeth requiring post and core restorations.
• Presence of draining sinus tract.
• Presence of periodontal pockets.
• Radiographic evidence of external or internal root resorption.
• Patients with a history of major surgeries (e.g., cardiac surgery, kidney transplantation).
• Patients undergoing hemodialysis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Group 1 ( Control ) : Traditional induced bleeding technique

Other group

Description:

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

Treatment:

Drug: Calcium Hydroxide (Ca(OH)2)

Group 2: Induced bleeding technique with application of Omega-3 Fatty Acids

Other group

Description:

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.

Treatment:

Drug: Omega -3 fatty acids

Drug: Calcium Hydroxide (Ca(OH)2)