Necrotic PulpNCT06886438
Periapical Bleeding Versus PRF Techniques in Regenerative Endodontic Therapy: A Randomized Controlled Trial
A study testing RVS, L-PRF and i-PRF in people with Necrotic Pulp and Regenerative Endodontic Procedures, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study investigates a biological approach that allows infected and necrotic teeth to heal themselves instead of being treated with traditional root canal therapy. Traditional root canal treatment involves cleaning the infected tissue inside the tooth and sealing it with a filling material, whereas regenerative… Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Necrotic Pulp, Regenerative Endodontic Procedures, Mature Teeth
- What is being tested?
- RVS, L-PRF and i-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2024to 24 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Single-rooted teeth with mature teeth with necrotic pulp requiring endodontic treatment, and a periapical lesion (Periapical Index Score (PAI) ≥3).
- Individuals without systemic diseases, not using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications, and not pregnant.
- Patients without acute pain.
- Patients without extraoral swelling, sinus tract, or acute apical abscess.
- Individuals willing to participate and able to attend follow-up sessions regularly.
Who cannot join
- Teeth with internal or external root resorption or vertical root fractures.
- Immature teeth.
- Individuals outside the age range of 14-65 years.
- Patients with complicated systemic diseases or those using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications.
- Patients with acute pain, those who have taken analgesic medication in the last 24 hours, or those who have used antibiotics within two weeks before treatment.
- Patients who are unlikely to attend follow-up sessions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Faculty of Dentistry, University of Health Sciences
Ankara, Etlik, 06010
About this study
Official title: Comparison of Regenerative Endodontic Procedures Using Periapical Bleeding Induction, L-PRF, and I-PRF in Mature Teeth With Periapical Lesions: A Randomized Controlled Clinical Trial
This study investigates a biological approach that allows infected and necrotic teeth to heal themselves instead of being treated with traditional root canal therapy. Traditional root canal treatment involves cleaning the infected tissue inside the tooth and sealing it with a filling material, whereas regenerative endodontic treatment is a novel approach that enables the tooth to repair itself. This treatment method involves inducing bleeding in the root area or applying special blood derivatives (PRF types) to accumulate healing-supporting cells and growth factors. The aim of the study is to compare the effects of different biological treatment methods on the healing process, postoperative pain, and tooth discoloration. The results may help develop more effective and aesthetically successful treatment options in the future.
Read the detailed description
This study investigates the effectiveness of regenerative endodontic procedures in the treatment of necrotic and infected teeth. Traditional root canal treatment involves the complete removal of infected tissue from inside the tooth and sealing the root canal with a biocompatible filling material. However, this method does not restore the tooth's natural vitality or protective mechanisms. Additionally, it may increase tooth fragility and lead to discoloration over time.
Regenerative endodontic treatment is a biological approach that promotes the self-healing of the tooth. This method applies tissue engineering principles to stimulate the formation of new tissue within the root canal. During the treatment process, either bleeding is induced at the root tip or special platelet-rich fibrin (PRF) derivatives are applied to facilitate the accumulation of stem cells, growth factors, and immune-boosting components that support healing.
This study compares the effects of different regenerative treatment methods (bleeding induction, L-PRF, and I-PRF applications) on lesion healing, postoperative pain, and tooth discoloration. By determining the most effective method for teeth with completed root development and apical lesions, the study aims to establish an optimal treatment protocol for clinical practice. The findings will contribute to the development of treatment options that preserve the natural structure of the tooth, enhance aesthetics, and improve patient comfort and long-term treatment success.
- Conditions
- Necrotic Pulp, Regenerative Endodontic Procedures, Mature Teeth, Apical Periodontitis, PRF, Discoloration of Teeth
- Being tested
- RVS, L-PRF, i-PRF
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVSProcedure or surgery
Revascularization
L-PRFProcedure or surgery
Regenerative endodontic procedure with L-PRF application
i-PRFProcedure or surgery
Regenerative endodontic procedure with i-PRF application
| Study group | Role | What they receive |
|---|---|---|
| AP | Experimental | Necrotic pulped, mature teeth with apical periodontitis. Receives: Procedure: RVS; Procedure: L-PRF; Procedure: i-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Assessment of Lesion Healing at 6 Months
Lesion healing will be evaluated using periapical radiographs with the parallel technique, and the Periapical Index (PAI) will be used for the assessment of lesion healing.
Measured: Baseline and 6 months
Change in Pain Level at 24 Hours, 72 Hours, and 1 Week Post-Treatment
Pain levels will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 100 (worst pain), measured at 24 hours, 72 hours, and 1 week post-procedure.
Measured: Post-Treatment at 24 Hours, 72 Hours, and 1 Week
Assessment of Tooth Discoloration at 6 Months
Tooth discoloration will be evaluated using a spectrophotometer based on the CIELab system, and teeth with a ΔE value greater than 3 will be considered discolored.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start3 Feb 2024
- Primary completion10 Mar 2024
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886438
- Sponsor's protocol ID
- HKORUCU1
- Other IDs
- 2023/056
- Status last verified
- Jan 2025
- First submitted
- 13 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The impact of gender differences on pain assessment in the study was also evaluated. Additionally, the effect of age on lesion healing was analyzed. Since the study examines the effects of demographic data on lesion healing and post-treatment pain, demographic data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Regenerative Endodontic Procedures Using Periapical Bleeding Induction, L-PRF, and I-PRF in Mature Teeth With Periapical Lesions: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06886438
- Acronym / sponsor ID
- HKORUCU1
- Conditions
- Necrotic Pulp, Regenerative Endodontic Procedures, Mature Teeth, Apical Periodontitis, PRF, Discoloration of Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 20 Mar 2025 (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 study investigates a biological approach that allows infected and necrotic teeth to heal themselves instead of being treated with traditional root canal therapy. Traditional root canal treatment involves cleaning the infected tissue inside the tooth and sealing it with a filling material, whereas regenerative endodontic treatment is a novel approach that enables the tooth to repair itself. This treatment method involves inducing bleeding in the root area or applying special blood derivatives (PRF types) to accumulate healing-supporting cells and growth factors. The aim of the study is to compare the effects of different biological treatment methods on the healing process, postoperative pain, and tooth discoloration. The results may help develop more effective and aesthetically successful treatment options in the future.
Detailed description
This study investigates the effectiveness of regenerative endodontic procedures in the treatment of necrotic and infected teeth. Traditional root canal treatment involves the complete removal of infected tissue from inside the tooth and sealing the root canal with a biocompatible filling material. However, this method does not restore the tooth's natural vitality or protective mechanisms. Additionally, it may increase tooth fragility and lead to discoloration over time.
Regenerative endodontic treatment is a biological approach that promotes the self-healing of the tooth. This method applies tissue engineering principles to stimulate the formation of new tissue within the root canal. During the treatment process, either bleeding is induced at the root tip or special platelet-rich fibrin (PRF) derivatives are applied to facilitate the accumulation of stem cells, growth factors, and immune-boosting components that support healing.
This study compares the effects of different regenerative treatment methods (bleeding induction, L-PRF, and I-PRF applications) on lesion healing, postoperative pain, and tooth discoloration. By determining the most effective method for teeth with completed root development and apical lesions, the study aims to establish an optimal treatment protocol for clinical practice. The findings will contribute to the development of treatment options that preserve the natural structure of the tooth, enhance aesthetics, and improve patient comfort and long-term treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AP | Experimental | Procedure: RVS, Procedure: L-PRF, Procedure: i-PRFNecrotic pulped, mature teeth with apical periodontitis. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Single-rooted teeth with mature teeth with necrotic pulp requiring endodontic treatment, and a periapical lesion (Periapical Index Score (PAI) ≥3).
- Individuals without systemic diseases, not using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications, and not pregnant.
- Patients without acute pain.
- Patients without extraoral swelling, sinus tract, or acute apical abscess.
- Individuals willing to participate and able to attend follow-up sessions regularly.
Key exclusion criteria (6 listed)
- Teeth with internal or external root resorption or vertical root fractures.
- Immature teeth.
- Individuals outside the age range of 14-65 years.
- Patients with complicated systemic diseases or those using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications.
- Patients with acute pain, those who have taken analgesic medication in the last 24 hours, or those who have used antibiotics within two weeks before treatment.
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 |
|---|---|---|
| RVSRevascularization | Procedure or surgery | AP |
| L-PRFRegenerative endodontic procedure with L-PRF application | Procedure or surgery | AP |
| i-PRFRegenerative endodontic procedure with i-PRF application | Procedure or surgery | AP |
Primary outcome
Radiographic Assessment of Lesion Healing at 6 Months
Time frame: Baseline and 6 months
Lesion healing will be evaluated using periapical radiographs with the parallel technique, and the Periapical Index (PAI) will be used for the assessment of lesion healing.
Change in Pain Level at 24 Hours, 72 Hours, and 1 Week Post-Treatment
Time frame: Post-Treatment at 24 Hours, 72 Hours, and 1 Week
Pain levels will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 100 (worst pain), measured at 24 hours, 72 hours, and 1 week post-procedure.
Assessment of Tooth Discoloration at 6 Months
Time frame: Baseline and 6 months
Tooth discoloration will be evaluated using a spectrophotometer based on the CIELab system, and teeth with a ΔE value greater than 3 will be considered discolored.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Yes. The impact of gender differences on pain assessment in the study was also evaluated. Additionally, the effect of age on lesion healing was analyzed. Since the study examines the effects of demographic data on lesion healing and post-treatment pain, demographic data will be shared.
Related trials for Necrotic Pulp
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Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
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The Impact of Using Different Final Irrigation Modes on Postoperative Pain Following Root Canal Treatment of Non-vital Mandibular First Molar With Periapical Lesion.
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Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT.
Necrotic Pulp With Symptomatic Apical Periodontitis
Recruiting
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Necrotic Pulp, Asymptomatic Apical Periodontitis
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 RVS, L-PRF and i-PRF in people with Necrotic Pulp and Regenerative Endodontic Procedures, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 20 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiographic Assessment of Lesion Healing at 6 Months (time frame: Baseline and 6 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 20 Mar 2025.