Immature Permanent Teeth With Open ApexRegenerationNCT07371416
Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
A study testing Omega -3 fatty acids and Calcium Hydroxide (Ca(OH)2) in people with Immature Permanent Teeth With Open Apex and Pulp Necrosis, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Immature Permanent Teeth With Open Apex, Pulp Necrosis
- What is being tested?
- Omega -3 fatty acids and Calcium Hydroxide (Ca(OH)2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Immature Teeth Treated With Regenerative Endodontic Procedures Using Intracanal Delivery of 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.
Read the 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.
- Being tested
- Omega -3 fatty acids, Calcium Hydroxide (Ca(OH)2)
- Keywords
- Regeneration, Immature Permanent Teeth
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega -3 fatty acidsDrug
Also called Omega-3 PUFAs
used within the Regenerative procedures
Calcium Hydroxide (Ca(OH)2)Drug
Also called Ca(OH)2
Used as intracanal medicament
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Omega -3 fatty acids; Drug: Calcium Hydroxide (Ca(OH)2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Root Length
Radiographic increase in root length (Millimeters (mm))
Measured: 12 months
Increase in Dentinal Wall Thickness
Radiographic increase in dentinal wall thickness measured using digital image analysis ( Millimeters (mm) )
Measured: 12 months
Periapical Bone Formation
Radiographic evidence of periapical bone formation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immature Permanent Teeth With Open ApexStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371416
- Sponsor's protocol ID
- MDP.25.04.8
- Acronym
- Regeneration
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Immature Teeth Treated With Regenerative Endodontic Procedures Using Intracanal Delivery of Omega-3 Fatty Acids
- ClinicalTrials.gov ID
- NCT07371416
- Acronym / sponsor ID
- Regeneration / MDP.25.04.8
- Keywords
- Regeneration, Immature Permanent Teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 ( Control ) : Traditional induced bleeding technique | Other | Drug: Calcium Hydroxide (Ca(OH)2)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 |
| Group 2: Induced bleeding technique with application of Omega-3 Fatty Acids | Other | Drug: Omega -3 fatty acids, Drug: Calcium Hydroxide (Ca(OH)2)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. |
Who may qualify
- Ages
- 6 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega -3 fatty acidsAlso: Omega-3 PUFAsused within the Regenerative procedures | Drug | Group 2: Induced bleeding technique with application of Omega-3 Fatty Acids |
| Calcium Hydroxide (Ca(OH)2)Also: Ca(OH)2Used as intracanal medicament | Drug | Group 1 ( Control ) : Traditional induced bleeding technique, Group 2: Induced bleeding technique with application of Omega-3 Fatty Acids |
Primary outcome
Increase in Root Length
Time frame: 12 months
Radiographic increase in root length (Millimeters (mm))
Increase in Dentinal Wall Thickness
Time frame: 12 months
Radiographic increase in dentinal wall thickness measured using digital image analysis ( Millimeters (mm) )
Periapical Bone Formation
Time frame: 12 months
Radiographic evidence of periapical bone formation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Related trials for Immature Permanent Teeth With Open Apex
Recruiting
Efficiency of Asiaticoside as Intracanal Medication in Revascularization Process
Immature Permanent Teeth With Open Apex, Pulp Necrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega -3 fatty acids and Calcium Hydroxide (Ca(OH)2) in people with Immature Permanent Teeth With Open Apex and Pulp Necrosis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Root Length (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.