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NCT Number: NCT07371416

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, 111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega -3 fatty acids

Drug

used within the Regenerative procedures

Other names: Omega-3 PUFAs

Calcium Hydroxide (Ca(OH)2)

Drug

Used as intracanal medicament

Other names: Ca(OH)2

Primary outcomes

  1. Increase in Root Length

    Time frame: 12 months

    Radiographic increase in root length (Millimeters (mm))

  2. Increase in Dentinal Wall Thickness

    Time frame: 12 months

    Radiographic increase in dentinal wall thickness measured using digital image analysis ( Millimeters (mm) )

  3. Periapical Bone Formation

    Time frame: 12 months

    Radiographic evidence of periapical bone formation

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: Regeneration

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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