Skip to content

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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07371416
Acronym
Regeneration
Enrollment
20
Registered
2026-01-28
Start date
2025-10-01
Completion date
2027-01-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immature Permanent Teeth With Open Apex, Pulp Necrosis

Keywords

Regeneration, Immature Permanent Teeth

Brief 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.

Interventions

used within the Regenerative procedures

Used as intracanal medicament

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 28 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Increase in Root Length12 monthsRadiographic increase in root length (Millimeters (mm))
Increase in Dentinal Wall Thickness12 monthsRadiographic increase in dentinal wall thickness measured using digital image analysis ( Millimeters (mm) )
Periapical Bone Formation12 monthsRadiographic evidence of periapical bone formation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026