Dental Pulp NecrosesPRFNCT05517187
Efficacy of Regenerative Endodontic Treatment With PRF as a Secondary Treatment of Mature Necrotic Incisors in Adolescents
A study testing Platelet rich fibrin in people with Dental Pulp Necroses, run by Nahda University at 2 sites in Egypt.
Trial summary
Evalaution of clinical success of secondary treatment for total 40 permanent incisors with failed root canal treatment with apical radiolucency. Twenty of of these permanent incisors will be treated with regenerative endodontic treatment(RET) with platelets rich fibrin PRF as intervention group vs. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Necroses
- What is being tested?
- Platelet rich fibrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Mar 2022to 1 Mar 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy patients below age of 18 years.
- Need endodontic retreatment of previously obturated closed apexes single-rooted incisors with gutta-percha.
- No previous attempts for endodontic retreatment.
- Presence of clinical signs and symptoms of chronic apical periodontitis
Who cannot join
- Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems were precluded.
- Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Nahda University
Banī Suwayf
Yasmin
- Recruiting
Nahda
Cairo
Yasmin
About this study
Official title: Clinical Success of Regenerative Endodontic Treatment With Platelets Rich Fibrin PRF as a Secondary Treatment of Mature Necrotic Incisors With Periapical Radiolucency in Adolescents: A Preliminary Parallel Randomized Controlled Clinical Trial
Evalaution of clinical success of secondary treatment for total 40 permanent incisors with failed root canal treatment with apical radiolucency.
Twenty of of these permanent incisors will be treated with regenerative endodontic treatment(RET) with platelets rich fibrin PRF as intervention group vs. 20 incisors control group secondary treated with (RET) with induced blood clot (BC).
Read the detailed description
A preliminary randomized parallel controlled trial will be conducted. Forty teeth of 36 patients were randomly assigned into two groups: group "PRF", treated with RET with PRF platelets rich fibrin (intervention), and group "BC", treated with RET with induced blood clot(control). Upon clinical examination, the presence of pain on biting or percussion, swelling or sinus tract, or abnormal tooth mobility will be considered a failure. To monitor the changes in periapical radiolucency, a periapical index (PAI) will be used. The primary outcome of the current study will be to assess the effectiveness of RET using PRF platelets rich fibrin of mature permanent incisors with periapical radiolucency compared to RET using induced BC formation in the root canal space.
Eligibility criteria:
Healthy adolescents below the age of 18 years who need endodontic retreatment of previously obturated mature single-rooted incisors with gutta-percha will be recruited.
Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems will be precluded. Only teeth diagnosed with asymptomatic apical periodontitis or chronic apical abscess (i.e. little discomfort with intermittent episodes of pus discharge through the sinus tract) were included. To confirm the clinical status, only teeth with a periapical index (PAI) score ≥3 based on Ørstavik et al classification were considered. Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns or need post placement, or periodontal problems were excluded. A tooth must not be a candidate for endodontic surgery according to Glickman et al. indications and the updates of the European Society of Endodontology (e.g. obtaining biopsy, removal of intracanal broken files, persistent periapical lesions standing for a long period, radicular perforation, root fracture, or obstructed root canals, or the inability of complete removal of old gutta-percha or extruded material beyond the apex with persistent apical lesion for long duration).
Interventions:
According to the latest RET operating guidelines issued by the American Academy of Endodontics (AAE) and the European Society of Endodontics (ESE), the standardised operating procedure of RET requires two treatment visits. During the first appointment, infection is controlled and inflammation is relieved with complete removal of failed obturation material. Pulp regeneration and revascularization is accomplished during the second appointment.
- Conditions
- Dental Pulp Necroses
- Being tested
- no intervention, Platelet rich fibrin
- Keywords
- platelet rich fibrin
- 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.
no interventionOther
Regenerative endodontic treatment induced with blood clot in root canal space as a secondary treatment for failed root canal treated incisors
Platelet rich fibrinBiological
Regenerative endodontic treatment with platelet rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors
| Study group | Role | What they receive |
|---|---|---|
| Blood Clot BC (Control arm) | Placebo comparator | Regenerative endodontic treatment with induced Blood Clot in root canal space as a secondary treatment for failed root canal treated incisors Receives: Other: no intervention |
| Platelets Rich Fibrin PRF (Intervention) | Experimental | Regenerative endodontic treatment with Platelet- rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors Receives: Biological: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Clinical assessment will be performed at the baseline (T0) and after 12 months (T1). Upon examination, clinical failure will be encountered if one of the following features will present: (i) pain on biting or percussion, (ii) swelling or sinus tract, or (iii) abnormal tooth mobility.
Measured: 12 months
Radiographic success
For a standardized appraisal of the changes in the size of periapical radiolucency, long cone "paralleling technique" with a receptor holder was used after mounting a size II periapical film (Kodak International) to a silicone bite stent.
Measured: 12 months
Secondary outcomes (1)
Pulp sensibility test
In the control and intervention groups, the pulp sensations will be tested with an electric pulp tester (EPT) (Pulp Tester DY 310, Denjoy Dental Co.) at T1 and T2.
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 posted26 Aug 2022
- Study start10 Mar 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
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 Dental Pulp NecrosesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmine mohamed farouk el makawi, Nahda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517187
- Sponsor's protocol ID
- 284
- Acronym
- PRF
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sermani DI, Abdelmotelb MA, Elheeny AAH. Postoperative pain after pulpotomy versus pulpectomy of primary molars with symptomatic irreversible pulpitis: an equivalent randomized clinical trial. BMC Oral Health. 2026 Apr 25;26(1):786. doi: 10.1186/s12903-026-08329-z.
PubMed 42035058
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Success of Regenerative Endodontic Treatment With Platelets Rich Fibrin PRF as a Secondary Treatment of Mature Necrotic Incisors With Periapical Radiolucency in Adolescents: A Preliminary Parallel Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05517187
- Acronym / sponsor ID
- PRF / 284
- Conditions
- Dental Pulp Necroses
- Keywords
- platelet rich fibrin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nahda UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 26 Aug 2022 (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.
Evalaution of clinical success of secondary treatment for total 40 permanent incisors with failed root canal treatment with apical radiolucency.
Twenty of of these permanent incisors will be treated with regenerative endodontic treatment(RET) with platelets rich fibrin PRF as intervention group vs. 20 incisors control group secondary treated with (RET) with induced blood clot (BC).
Detailed description
A preliminary randomized parallel controlled trial will be conducted. Forty teeth of 36 patients were randomly assigned into two groups: group "PRF", treated with RET with PRF platelets rich fibrin (intervention), and group "BC", treated with RET with induced blood clot(control). Upon clinical examination, the presence of pain on biting or percussion, swelling or sinus tract, or abnormal tooth mobility will be considered a failure. To monitor the changes in periapical radiolucency, a periapical index (PAI) will be used. The primary outcome of the current study will be to assess the effectiveness of RET using PRF platelets rich fibrin of mature permanent incisors with periapical radiolucency compared to RET using induced BC formation in the root canal space.
Eligibility criteria:
Healthy adolescents below the age of 18 years who need endodontic retreatment of previously obturated mature single-rooted incisors with gutta-percha will be recruited.
Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems will be precluded. Only teeth diagnosed with asymptomatic apical periodontitis or chronic apical abscess (i.e. little discomfort with intermittent episodes of pus discharge through the sinus tract) were included. To confirm the clinical status, only teeth with a periapical index (PAI) score ≥3 based on Ørstavik et al classification were considered. Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns or need post placement, or periodontal problems were excluded. A tooth must not be a candidate for endodontic surgery according to Glickman et al. indications and the updates of the European Society of Endodontology (e.g. obtaining biopsy, removal of intracanal broken files, persistent periapical lesions standing for a long period, radicular perforation, root fracture, or obstructed root canals, or the inability of complete removal of old gutta-percha or extruded material beyond the apex with persistent apical lesion for long duration).
Interventions:
According to the latest RET operating guidelines issued by the American Academy of Endodontics (AAE) and the European Society of Endodontics (ESE), the standardised operating procedure of RET requires two treatment visits. During the first appointment, infection is controlled and inflammation is relieved with complete removal of failed obturation material. Pulp regeneration and revascularization is accomplished during the second appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Clot BC (Control arm) | Placebo comparator | Other: no interventionRegenerative endodontic treatment with induced Blood Clot in root canal space as a secondary treatment for failed root canal treated incisors |
| Platelets Rich Fibrin PRF (Intervention) | Experimental | Biological: Platelet rich fibrinRegenerative endodontic treatment with Platelet- rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy patients below age of 18 years.
- Need endodontic retreatment of previously obturated closed apexes single-rooted incisors with gutta-percha.
- No previous attempts for endodontic retreatment.
- Presence of clinical signs and symptoms of chronic apical periodontitis
Key exclusion criteria (2 listed)
- Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems were precluded.
- Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns
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 |
|---|---|---|
| no interventionRegenerative endodontic treatment induced with blood clot in root canal space as a secondary treatment for failed root canal treated incisors | Other | Blood Clot BC (Control arm) |
| Platelet rich fibrinRegenerative endodontic treatment with platelet rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors | Biological | Platelets Rich Fibrin PRF (Intervention) |
Primary outcome
Clinical success
Time frame: 12 months
Clinical assessment will be performed at the baseline (T0) and after 12 months (T1). Upon examination, clinical failure will be encountered if one of the following features will present: (i) pain on biting or percussion, (ii) swelling or sinus tract, or (iii) abnormal tooth mobility.
Radiographic success
Time frame: 12 months
For a standardized appraisal of the changes in the size of periapical radiolucency, long cone "paralleling technique" with a receptor holder was used after mounting a size II periapical film (Kodak International) to a silicone bite stent.
1 secondary outcome
Pulp sensibility test
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 42035058Sermani DI, Abdelmotelb MA, Elheeny AAH. Postoperative pain after pulpotomy versus pulpectomy of primary molars with symptomatic irreversible pulpitis: an equivalent randomized clinical trial. BMC Oral Health. 2026 Apr 25;26(1):786. doi: 10.1186/s12903-026-08329-z.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich fibrin in people with Dental Pulp Necroses, run by Nahda University at 2 sites 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 2 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 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Contact Yassmine Farouk Mekawi, PhD (01006526611, yassmin.mohamed@nub.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05517187, 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 31 Aug 2022.