Necrotic PulpNCT04606719
Healing Potentiality Of Blood Clot S-PRF and A-PRF in the Treatment Of Necrotic Mature Single-Rooted Teeth With Chronic Peri-Apical Periodontitis
A study testing Advanced Platelet Rich fibrin in people with Necrotic Pulp, run by Cairo University at 1 site in Egypt.
Trial summary
Earlier, it was believed that successful regeneration cannot be achieved once tooth has become infected. However, recent studies suggest that regenerative endodontics may in fact be possible in teeth with pulpal necrosis and periapical pathology. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- Advanced Platelet Rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Sep 2023
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients who accept to participate in the study.
- Age between 18-35 years old with no sex predilection.
- Patients with good oral hygiene.
- Patients with necrotic pulp in mandibular \& maxillary single rooted permanent teeth with mature apex that Symptomatic or Asymptomatic , Doesn't respond positively with the electric pulp tester ,Associated with or without swelling /sinus tract, Has radiographic evidence of periapical radiolucency, Has a straight, non-curved root, Teeth with normal occlusal contact with the opposing teeth.
Who cannot join
- Illiterate patient because they can't estimate the pain level on the pain scale (NRS).
- Patients with systemic diseases or on systemic corticosteroids therapy because they have impaired healing and higher incidence of pain.
- Pregnant women to avoid radiation exposure during the treatment which may be hazardous to the fetus and breasts from dental X-ray examinations shields.
- Patients that have allergy to ciprofloxacin or metronidazole to avoid any allergic reaction after placement of bi-antibiotic paste as intra-canal medication.
- Patients reporting bruxism or clenching because this induce more pressure on teeth and may initiate the post-operative pain in the treated tooth which is already have peri-apical inflammation
- Teeth that, Have vertical root fracture, coronal perforation, and calcification, Are indicated for retreatment because they have lower success rate , Have pocket depth greater than 5mm,Need periodontal therapy , Non restorable , Hopeless tooth, patients that have T.M.J disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing Potentiality Of Blood Clot, S-PRF and A-PRF As Scaffold In Treatment Of Non-Vital Mature Single Rooted Teeth With Chronic Peri-Apical Periodontitis Following Regenerative Endodontic Therapy (Randomized Clinical Trial)
Earlier, it was believed that successful regeneration cannot be achieved once tooth has become infected. However, recent studies suggest that regenerative endodontics may in fact be possible in teeth with pulpal necrosis and periapical pathology.
The primary goal in regenerative procedure is to eliminate clinical symptoms and resolve apical periodontitis. The blood clot acts as a scaffold, and the growth factors inside recruit stem cells, most likely from periapical papilla. But unfortunately, the erythrocytes in the clot of the blood column undergo necrosis, affecting its properties so the blood column is augmented by the use of different types of scaffolds.
Platelet-rich fibrin is classified into four types (Standard PRF, Injectable PRF, Advanced PRF and Concentrated Growth Factor CGF) according to speed and time of centrifuge with the overall aim to increase the number of platelets and leucocytes
- Conditions
- Necrotic Pulp
- Being tested
- Advanced Platelet Rich fibrin
- Keywords
- Regeneration . Necrotic . Mature teeth . Blood clot . PRF
- 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.
Advanced Platelet Rich fibrinProcedure or surgery
Preparing of A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes
| Study group | Role | What they receive |
|---|---|---|
| Blood Clot | Other | It is induced through apical foramen by penetrating the periapical area by stainless steel file size 30 to fill the root canal system by growth factors also to be considered as scaffold Receives: Procedure: Advanced Platelet Rich fibrin |
| Standard PRF | Active comparator | Standard Platelet-rich fibrin will be prepared by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 3000 rpm for 10 min. After centrifugation, three layers will formed in the test tube-base layer of RBCs, top layer of a-cellular plasma, and a PRF clot in the middle. This clot will then pressed between two gauze pieces to form a membrane. Receives: Procedure: Advanced Platelet Rich fibrin |
| Advanced PRF | Experimental | A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes Receives: Procedure: Advanced Platelet Rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing Rate
standardized digital radiograph
Measured: follow up to 6 months
Secondary outcomes (2)
Postoperative pain: NRS
using neumerical rationg scale NRS . from zero to 10 . zero = no pain 1 to 3 = mild 4-6 = moderate 7-10 = severe
Measured: up to one year
sensitivty
using sensitivity tests
Measured: 6 months to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Badawy Darwish, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606719
- Sponsor's protocol ID
- ENDO 5-6-1
- Status last verified
- Feb 2024
- First submitted
- 25 Oct 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Darwish OB, Aziz SMA, Sadek HS. Healing potentiality of blood clot, S-PRF and A-PRF as scaffold in treatment of non-vital mature single rooted teeth with chronic peri-apical periodontitis following regenerative endodontic therapy: randomized clinical trial. BMC Oral Health. 2025 Jan 9;25(1):50. doi: 10.1186/s12903-024-05378-0.
PubMed 39789544
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Potentiality Of Blood Clot, S-PRF and A-PRF As Scaffold In Treatment Of Non-Vital Mature Single Rooted Teeth With Chronic Peri-Apical Periodontitis Following Regenerative Endodontic Therapy (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04606719
- Acronym / sponsor ID
- ENDO 5-6-1
- Conditions
- Necrotic Pulp
- Keywords
- Regeneration . Necrotic . Mature teeth . Blood clot . PRF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 Oct 2020 (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.
Earlier, it was believed that successful regeneration cannot be achieved once tooth has become infected. However, recent studies suggest that regenerative endodontics may in fact be possible in teeth with pulpal necrosis and periapical pathology.
The primary goal in regenerative procedure is to eliminate clinical symptoms and resolve apical periodontitis. The blood clot acts as a scaffold, and the growth factors inside recruit stem cells, most likely from periapical papilla. But unfortunately, the erythrocytes in the clot of the blood column undergo necrosis, affecting its properties so the blood column is augmented by the use of different types of scaffolds.
Platelet-rich fibrin is classified into four types (Standard PRF, Injectable PRF, Advanced PRF and Concentrated Growth Factor CGF) according to speed and time of centrifuge with the overall aim to increase the number of platelets and leucocytes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood Clot | Other | Procedure: Advanced Platelet Rich fibrinIt is induced through apical foramen by penetrating the periapical area by stainless steel file size 30 to fill the root canal system by growth factors also to be considered as scaffold |
| Standard PRF | Active comparator | Procedure: Advanced Platelet Rich fibrinStandard Platelet-rich fibrin will be prepared by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 3000 rpm for 10 min. After centrifugation, three layers will formed in the test tube-base layer of RBCs, top layer of a-cellular plasma, and a PRF clot in the middle. This clot will then pressed between two gauze pieces to form a membrane. |
| Advanced PRF | Experimental | Procedure: Advanced Platelet Rich fibrinA-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Medically free patients who accept to participate in the study.
- Age between 18-35 years old with no sex predilection.
- Patients with good oral hygiene.
- Patients with necrotic pulp in mandibular \& maxillary single rooted permanent teeth with mature apex that Symptomatic or Asymptomatic , Doesn't respond positively with the electric pulp tester ,Associated with or without swelling /sinus tract, Has radiographic evidence of periapical radiolucency, Has a straight, non-curved root, Teeth with normal occlusal contact with the opposing teeth.
Key exclusion criteria (6 listed)
- Illiterate patient because they can't estimate the pain level on the pain scale (NRS).
- Patients with systemic diseases or on systemic corticosteroids therapy because they have impaired healing and higher incidence of pain.
- Pregnant women to avoid radiation exposure during the treatment which may be hazardous to the fetus and breasts from dental X-ray examinations shields.
- Patients that have allergy to ciprofloxacin or metronidazole to avoid any allergic reaction after placement of bi-antibiotic paste as intra-canal medication.
- Patients reporting bruxism or clenching because this induce more pressure on teeth and may initiate the post-operative pain in the treated tooth which is already have peri-apical inflammation
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 |
|---|---|---|
| Advanced Platelet Rich fibrinPreparing of A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes | Procedure or surgery | Advanced PRF, Blood Clot, Standard PRF |
Primary outcome
healing Rate
Time frame: follow up to 6 months
standardized digital radiograph
2 secondary outcomes
Postoperative pain: NRS
Time frame: up to one year
sensitivty
Time frame: 6 months to one year
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 Feb 2024.
- Derived from this study: PubMed 39789544Darwish OB, Aziz SMA, Sadek HS. Healing potentiality of blood clot, S-PRF and A-PRF as scaffold in treatment of non-vital mature single rooted teeth with chronic peri-apical periodontitis following regenerative endodontic therapy: randomized clinical trial. BMC Oral Health. 2025 Jan 9;25(1):50. doi: 10.1186/s12903-024-05378-0.
Related trials for Necrotic Pulp
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, 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 Advanced Platelet Rich fibrin in people with Necrotic Pulp, run by Cairo 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 4 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 Feb 2024. 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?
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?
healing Rate (time frame: follow up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606719, which also lists 1 linked publication.
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 Feb 2024.