NCT07371416

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Jan 2027

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

January 9, 2026

Last Update Submit

January 19, 2026

Conditions

Immature Permanent Teeth With Open ApexPulp Necrosis

Keywords

RegenerationImmature Permanent Teeth

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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

Drug: Calcium Hydroxide (Ca(OH)2)

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.

Drug: Omega -3 fatty acidsDrug: Calcium Hydroxide (Ca(OH)2)

Interventions

Omega -3 fatty acidsDRUG

used within the Regenerative procedures

Also known as: Omega-3 PUFAs
Group 2: Induced bleeding technique with application of Omega-3 Fatty Acids
Calcium Hydroxide (Ca(OH)2)DRUG

Used as intracanal medicament

Also known as: Ca(OH)2
Group 1 ( Control ) : Traditional induced bleeding techniqueGroup 2: Induced bleeding technique with application of Omega-3 Fatty Acids

Eligibility Criteria

Age6 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 111, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Docosahexaenoic AcidsCalcium Hydroxide

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsHydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 28, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

EG(1)