Apical PeriodontitisNCT06086249
Clinical and Radiographic Success of Regeneration Using Injectable Platelet Rich Fibrin
A study testing Regeneration using Injectable platelet-rich fibrin and Root canal treatment in people with Apical Periodontitis, run by Cairo University.
Trial summary
Study aimed at assessing the clinical and radiographic success of pulp regeneration using injectable platelet-rich fibrin in mature permanent molars with apical periodontitis versus root canal treatment using Gutta Percha (GP) obturation. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Regeneration using Injectable platelet-rich fibrin and Root canal treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Feb 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 10-15 years.
- First Permanent molar diagnosed with apical periodontitis.
- A cooperative and compliant patient/ parent.
- Patients not allergic to medicaments necessary to complete the procedure.
- Patients with no history of chronic systemic diseases.
Who cannot join
- Teeth indicated for post and core.
- Non-restorable tooth.
- Previous root canal treatment.
- Curved canal of more than 25°.
- Periodontal pocket larger than 3 mm.
- Teeth with developmental anomalies.
About this study
Official title: Clinical and Radiographic Success of Regeneration Using Injectable Platelet Rich Fibrin Versus Root Canal Treatment in Mature Permanent Molars With Apical Periodontitis: A Randomized Controlled Pilot Study
Study aimed at assessing the clinical and radiographic success of pulp regeneration using injectable platelet-rich fibrin in mature permanent molars with apical periodontitis versus root canal treatment using Gutta Percha (GP) obturation.
Read the detailed description
Randomized pilot study, parallel groups design with 1:1 allocation ratio.
PICOT:
Population: Mature first permanent molar with apical periodontitis. Intervention: Regeneration using injectable platelet-rich fibrin. Control: Root canal treatment using GP obturation. outcomes: clinical and radiographic success. Source of patients: this study will be conducted in the outpatient postgraduate clinic of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University, Egypt.
Written Informed consent from participating children/parents. Baseline records photographs, clinical inspection, percussion test, periapical radiograph, and personal data collection will be conducted.
A diagnostic chart with personal, medical, and dental history will be filled Diagnosis and treatment of the cases will be performed according to the Treatment Standards of the American Association of Endodontists (AAE) 2020 of Non-Surgical Endodontics for the Uncomplicated Mature Permanent Teeth.
Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of treatment then writing the patient's name and I.D. on it and will be opened in the next visit).
The radiographic examination will be performed by taking a periapical X-ray using (a parallel technique) to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any vertical dimension distortion and provide reproducible images using an X-ray holding device.
An individual XCP (Extension Cone Paralleling) index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs.
Intra-operative procedure:
First appointment:
- Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000 using inferior alveolar nerve block.
- Rubber dam will be applied, then caries removal and access cavity preparation will be established using a sterile carbide bur no. 8, and Endo Z bur.
- Initial canal exploration will be performed with Endo Probe and no. 10 K-file to gauge canal size, shape, and configuration. Working length will be determined using an apex locator with no 15-hand K-file that will be kept 0.3 mm short of the radiographic apex and will be confirmed radiographically.
- Then, the root canal preparation will be done as follows:
Rotary instrumentation will be preceded by manual hand instrumentation using no 20 K-file to check the patency. Then, the rotary instrumentation will be done using rotary files.
EDTA gel will be used as a lubricating paste during canal preparation with rotary files.
Sodium hypochlorite (1.5%) and saline irrigation using a side vented needle into the apical third of the canal to remove debris with copious irrigation using ultrasonic irrigation.
Dryness will be done using paper points size 30. The root canal will be filled homogeneously to the working length with Calcium Hydroxide paste (Metapaste), then, a small Teflon will be applied above the orifices and the tooth will be temporarily restored with Glass Ionomer restorative material till the next appointment.
Second appointment:
All the patients will be recalled after 3 weeks, if the symptoms are suggestive of persistent infection, the root canals will be re-irrigated with sodium hypochlorite followed by saline, and reinjected with calcium hydroxide paste. If the symptoms are relieved, patients will proceed to the next step.
- A 1.8-mL of articaine 4% with epinephrine 1:100000 will be administered as inferior alveolar nerve block. The rubber dam will be placed, and the glass ionomer cement and Teflon will be removed. The root canals will be agitated with master apical K-file and re-irrigated using 17% EDTA solution followed by saline irrigation, then the canals will be dried using a paper point.
- For the intervention group, I-PRF Regeneration will be applied.
- For the control group, root canal treatment will be applied.
- Follow up:
Clinical evaluation will be performed on 1, 3, 6, 9, and 12 months post-operatively.
Radiographic evaluation will be performed pre-operatively (baseline), and postoperative following the second appointment at 6, and 12 months using the individualized XCP (Extension Cone Paralleling) index and the Digital X-ray machine.
- Conditions
- Apical Periodontitis
- Being tested
- Regeneration using Injectable platelet-rich fibrin, Root canal treatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regeneration using Injectable platelet-rich fibrinProcedure or surgery
root canals of affected molars will be cleaned and shaped chemo-mechanically, after two weeks I-PRF will be applied.
Root canal treatmentProcedure or surgery
Conventional root canal treatment using gutta-percha obturation
| Study group | Role | What they receive |
|---|---|---|
| Regeneration using Injectable platelet-rich fibrin | Experimental | A 10-mL sample of whole venous blood will be drawn from the patient's forearm (median cubital vein). It will be centrifuged immediately by a tabletop centrifuge at 700 rpm for 3 minutes at room temperature. Injectable platelet-rich fibrin (I-PRF) will be collected. After that, the I-PRF will be injected inside the canals using a plastic syringe needle that will be placed 1mm short of the working length and withdrawn gradually while injecting till reaching the orifices of the canals. After that, a Collagen membrane matrix will be placed above the canal orifice and will left for 5 minutes to partially harden, then a 3 mm thick layer of MTA will be placed directly over it. The cavity will be sealed with composite and covered with a stainless steel crown. Receives: Procedure: Regeneration using Injectable platelet-rich fibrin |
| Root canal treatment | Active comparator | The root canal will be obturated with gutta-percha by the cold lateral condensation technique with epoxy resin-based root canal sealer, the cavity will be sealed with composite and covered with a stainless steel crown. Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Clinical Success is a composite outcome and will be recorded as Clinically Successful or Clinically Unsuccessful based on the following evaluation criteria:
Clinically Successful: Following assigned treatment in case of absence of all of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain.
Clinically unsuccessful: Following assigned treatment in case of presence of any of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain.
Measured: 1, 3, 6, 9 and 12 months
Secondary outcomes (2)
Radiographic success
The scores will be follow:
- Absence of the periapical lesion; if the postoperative radiographic periodontal space is smaller than 0.5 mm.
- Reduction of the periapical lesion; if the postoperative radiographic lesion is smaller than approximately 20% of the preoperative radiographic lesion.
- Enlargement of the periapical lesion; if the postoperative radiographic lesion is bigger than approximately 20% of the preoperative radiographic lesion.
- Uncertain: if the case cannot be defined as absence, reduction, or enlargement of the periapical lesion, periapical rarefaction 1 mm or less, extraction of tooth before recall because of reasons not related to outcome of endodontic treatment.
Measured: 6 and 12 months
Overall success
The treatment will be scored as Success in case there is absence or reduction of the radiolucency (score 1 or 2), in addition to being clinically asymptomatic with no sinus tract, swelling, with no spontaneous, palpation, or percussions pain. On the other side, if the case showed a score of 3 or 4 radiographically or a symptomatic tooth, the case was recorded as Failure.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Mohsen Kanzel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086249
- Sponsor's protocol ID
- 102032
- Status last verified
- Feb 2024
- First submitted
- 9 Oct 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.
PubMed 35030270Rafiee A, Memarpour M, Najibi Y, Khalvati B, Kianpour S, Morowvat MH. Antimicrobial Efficacy of a Novel Antibiotic-Eluting Injectable Platelet-Rich Fibrin Scaffold against a Dual-Species Biofilm in an Infected Immature Root Canal Model. Biomed Res Int. 2020 Dec 8;2020:6623830. doi: 10.1155/2020/6623830. eCollection 2020.
PubMed 33490247Aydinyurt HS, Sancak T, Taskin C, Basbugan Y, Akinci L. Effects of injectable platelet-rich fibrin in experimental periodontitis in rats. Odontology. 2021 Apr;109(2):422-432. doi: 10.1007/s10266-020-00557-1. Epub 2020 Oct 17.
PubMed 33068206Taylor GD, Vernazza CR, Abdulmohsen B. Success of endodontic management of compromised first permanent molars in children: A systematic review. Int J Paediatr Dent. 2020 May;30(3):370-380. doi: 10.1111/ipd.12599. Epub 2019 Dec 13.
PubMed 31778237Nageh M, Ahmed GM, El-Baz AA. Assessment of Regaining Pulp Sensibility in Mature Necrotic Teeth Using a Modified Revascularization Technique with Platelet-rich Fibrin: A Clinical Study. J Endod. 2018 Oct;44(10):1526-1533. doi: 10.1016/j.joen.2018.06.014. Epub 2018 Aug 31.
PubMed 30174103Gollapudi M, Bajaj P, Oza RR. Injectable Platelet-Rich Fibrin - A Revolution in Periodontal Regeneration. Cureus. 2022 Aug 31;14(8):e28647. doi: 10.7759/cureus.28647. eCollection 2022 Aug.
PubMed 36196318Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.
PubMed 31155298Jha P, Virdi MS, Nain S. A Regenerative Approach for Root Canal Treatment of Mature Permanent Teeth: Comparative Evaluation with 18 Months Follow-up. Int J Clin Pediatr Dent. 2019 May-Jun;12(3):182-188. doi: 10.5005/jp-journals-10005-1616.
PubMed 31708612Brizuela C, Meza G, Urrejola D, Quezada MA, Concha G, Ramirez V, Angelopoulos I, Cadiz MI, Tapia-Limonchi R, Khoury M. Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial. J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.
PubMed 32202965Ibrahim LA, Tawfik MN, Naeem FMA. Evaluation of The Periapical Healing Following Pulp Revascularization Using Injectable PRF VS nonsurgical Root Canal Treatment in Mature Permanent Teeth with periapical periodontitis. A Clinical Study. Egypt Dent J. 2021;67(3):2663-2672
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Success of Regeneration Using Injectable Platelet Rich Fibrin Versus Root Canal Treatment in Mature Permanent Molars With Apical Periodontitis: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06086249
- Acronym / sponsor ID
- 102032
- Conditions
- Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 17 Oct 2023 (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.
Study aimed at assessing the clinical and radiographic success of pulp regeneration using injectable platelet-rich fibrin in mature permanent molars with apical periodontitis versus root canal treatment using Gutta Percha (GP) obturation.
Detailed description
Randomized pilot study, parallel groups design with 1:1 allocation ratio.
PICOT:
Population: Mature first permanent molar with apical periodontitis. Intervention: Regeneration using injectable platelet-rich fibrin. Control: Root canal treatment using GP obturation. outcomes: clinical and radiographic success. Source of patients: this study will be conducted in the outpatient postgraduate clinic of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University, Egypt.
Written Informed consent from participating children/parents. Baseline records photographs, clinical inspection, percussion test, periapical radiograph, and personal data collection will be conducted.
A diagnostic chart with personal, medical, and dental history will be filled Diagnosis and treatment of the cases will be performed according to the Treatment Standards of the American Association of Endodontists (AAE) 2020 of Non-Surgical Endodontics for the Uncomplicated Mature Permanent Teeth.
Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of treatment then writing the patient's name and I.D. on it and will be opened in the next visit).
The radiographic examination will be performed by taking a periapical X-ray using (a parallel technique) to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any vertical dimension distortion and provide reproducible images using an X-ray holding device.
An individual XCP (Extension Cone Paralleling) index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs.
Intra-operative procedure:
First appointment:
- Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000 using inferior alveolar nerve block.
- Rubber dam will be applied, then caries removal and access cavity preparation will be established using a sterile carbide bur no. 8, and Endo Z bur.
- Initial canal exploration will be performed with Endo Probe and no. 10 K-file to gauge canal size, shape, and configuration. Working length will be determined using an apex locator with no 15-hand K-file that will be kept 0.3 mm short of the radiographic apex and will be confirmed radiographically.
- Then, the root canal preparation will be done as follows:
Rotary instrumentation will be preceded by manual hand instrumentation using no 20 K-file to check the patency. Then, the rotary instrumentation will be done using rotary files.
EDTA gel will be used as a lubricating paste during canal preparation with rotary files.
Sodium hypochlorite (1.5%) and saline irrigation using a side vented needle into the apical third of the canal to remove debris with copious irrigation using ultrasonic irrigation.
Dryness will be done using paper points size 30. The root canal will be filled homogeneously to the working length with Calcium Hydroxide paste (Metapaste), then, a small Teflon will be applied above the orifices and the tooth will be temporarily restored with Glass Ionomer restorative material till the next appointment.
Second appointment:
All the patients will be recalled after 3 weeks, if the symptoms are suggestive of persistent infection, the root canals will be re-irrigated with sodium hypochlorite followed by saline, and reinjected with calcium hydroxide paste. If the symptoms are relieved, patients will proceed to the next step.
- A 1.8-mL of articaine 4% with epinephrine 1:100000 will be administered as inferior alveolar nerve block. The rubber dam will be placed, and the glass ionomer cement and Teflon will be removed. The root canals will be agitated with master apical K-file and re-irrigated using 17% EDTA solution followed by saline irrigation, then the canals will be dried using a paper point.
- For the intervention group, I-PRF Regeneration will be applied.
- For the control group, root canal treatment will be applied.
- Follow up:
Clinical evaluation will be performed on 1, 3, 6, 9, and 12 months post-operatively.
Radiographic evaluation will be performed pre-operatively (baseline), and postoperative following the second appointment at 6, and 12 months using the individualized XCP (Extension Cone Paralleling) index and the Digital X-ray machine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regeneration using Injectable platelet-rich fibrin | Experimental | Procedure: Regeneration using Injectable platelet-rich fibrinA 10-mL sample of whole venous blood will be drawn from the patient's forearm (median cubital vein). It will be centrifuged immediately by a tabletop centrifuge at 700 rpm for 3 minutes at room temperature. Injectable platelet-rich fibrin (I-PRF) will be collected. After that, the I-PRF will be injected inside the canals using a plastic syringe needle that will be placed 1mm short of the working length and withdrawn gradually while injecting till reaching the orifices of the canals. After that, a Collagen membrane matrix will be placed above the canal orifice and will left for 5 minutes to partially harden, then a 3 mm thick layer of MTA will be placed directly over it. The cavity will be sealed with composite and covered with a stainless steel crown. |
| Root canal treatment | Active comparator | Procedure: Root canal treatmentThe root canal will be obturated with gutta-percha by the cold lateral condensation technique with epoxy resin-based root canal sealer, the cavity will be sealed with composite and covered with a stainless steel crown. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 10-15 years.
- First Permanent molar diagnosed with apical periodontitis.
- A cooperative and compliant patient/ parent.
- Patients not allergic to medicaments necessary to complete the procedure.
- Patients with no history of chronic systemic diseases.
Key exclusion criteria (6 listed)
- Teeth indicated for post and core.
- Non-restorable tooth.
- Previous root canal treatment.
- Curved canal of more than 25°.
- Periodontal pocket larger than 3 mm.
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 |
|---|---|---|
| Regeneration using Injectable platelet-rich fibrinroot canals of affected molars will be cleaned and shaped chemo-mechanically, after two weeks I-PRF will be applied. | Procedure or surgery | Regeneration using Injectable platelet-rich fibrin |
| Root canal treatmentConventional root canal treatment using gutta-percha obturation | Procedure or surgery | Root canal treatment |
Primary outcome
Clinical success
Time frame: 1, 3, 6, 9 and 12 months
Clinical Success is a composite outcome and will be recorded as Clinically Successful or Clinically Unsuccessful based on the following evaluation criteria: Clinically Successful: Following assigned treatment in case of absence of all of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain. Clinically unsuccessful: Following assigned treatment in case of presence of any of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain.
2 secondary outcomes
Radiographic success
Time frame: 6 and 12 months
Overall success
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 35030270Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.
- Background: PubMed 33490247Rafiee A, Memarpour M, Najibi Y, Khalvati B, Kianpour S, Morowvat MH. Antimicrobial Efficacy of a Novel Antibiotic-Eluting Injectable Platelet-Rich Fibrin Scaffold against a Dual-Species Biofilm in an Infected Immature Root Canal Model. Biomed Res Int. 2020 Dec 8;2020:6623830. doi: 10.1155/2020/6623830. eCollection 2020.
- Background: PubMed 33068206Aydinyurt HS, Sancak T, Taskin C, Basbugan Y, Akinci L. Effects of injectable platelet-rich fibrin in experimental periodontitis in rats. Odontology. 2021 Apr;109(2):422-432. doi: 10.1007/s10266-020-00557-1. Epub 2020 Oct 17.
- Background: PubMed 31778237Taylor GD, Vernazza CR, Abdulmohsen B. Success of endodontic management of compromised first permanent molars in children: A systematic review. Int J Paediatr Dent. 2020 May;30(3):370-380. doi: 10.1111/ipd.12599. Epub 2019 Dec 13.
- Background: PubMed 30174103Nageh M, Ahmed GM, El-Baz AA. Assessment of Regaining Pulp Sensibility in Mature Necrotic Teeth Using a Modified Revascularization Technique with Platelet-rich Fibrin: A Clinical Study. J Endod. 2018 Oct;44(10):1526-1533. doi: 10.1016/j.joen.2018.06.014. Epub 2018 Aug 31.
- Background: PubMed 36196318Gollapudi M, Bajaj P, Oza RR. Injectable Platelet-Rich Fibrin - A Revolution in Periodontal Regeneration. Cureus. 2022 Aug 31;14(8):e28647. doi: 10.7759/cureus.28647. eCollection 2022 Aug.
- Background: PubMed 31155298Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.
- Background: PubMed 31708612Jha P, Virdi MS, Nain S. A Regenerative Approach for Root Canal Treatment of Mature Permanent Teeth: Comparative Evaluation with 18 Months Follow-up. Int J Clin Pediatr Dent. 2019 May-Jun;12(3):182-188. doi: 10.5005/jp-journals-10005-1616.
- Background: PubMed 32202965Brizuela C, Meza G, Urrejola D, Quezada MA, Concha G, Ramirez V, Angelopoulos I, Cadiz MI, Tapia-Limonchi R, Khoury M. Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial. J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.
- BackgroundIbrahim LA, Tawfik MN, Naeem FMA. Evaluation of The Periapical Healing Following Pulp Revascularization Using Injectable PRF VS nonsurgical Root Canal Treatment in Mature Permanent Teeth with periapical periodontitis. A Clinical Study. Egypt Dent J. 2021;67(3):2663-2672
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Regeneration using Injectable platelet-rich fibrin and Root canal treatment in people with Apical Periodontitis, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Clinical success (time frame: 1, 3, 6, 9 and 12 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 NCT06086249, which also lists 10 linked publications.
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 9 Feb 2024.