Pulp NecrosesPhase 2NCT04390854
Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth
A Phase 2 study testing Blood clot scaffold and Blood clot scaffold combined with PRF in people with Pulp Necroses, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pulp Necroses
- What is being tested?
- Blood clot scaffold and Blood clot scaffold combined with PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jul 2018to 30 Aug 2020
- Phase
- Phase 2
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Necrotic incisors with immature roots
- Pulp space not needed for post and core.
- The patient has to be free from any coagulation disorders, with normal platelets count.
- Good oral hygiene
- Cooperative patient
Who cannot join
- Internal or external root resorption.
- Root fracture and/or alveolar fracture.
- Previous root canal treatment.
- Medically compromised patients
- Uncooperative patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)
The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.
Read the detailed description
30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.
- Conditions
- Pulp Necroses
- Being tested
- Blood clot scaffold, Blood clot scaffold combined with PRF
- Keywords
- Regenerative endodontics, Open apex, Immature necrotic 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.
Blood clot scaffoldBiological
Bleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction.
Biodentine will be placed approximately 3-4 mm below the cementoenamel junction.
Blood clot scaffold combined with PRFBiological
Platelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge** at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold.
| Study group | Role | What they receive |
|---|---|---|
| Induced blood clot scaffold | Active comparator | Not described Receives: Biological: Blood clot scaffold |
| Induced blood clot scaffold combined with Platelet rich fibrin | Experimental | Not described Receives: Biological: Blood clot scaffold combined with PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain assessment
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Measured: 1 month
Subjective pain assessment
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Measured: 3 months
Subjective pain assessment
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Measured: 6 months
Subjective pain assessment
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Measured: 12 months
Assessment of pulp vitality
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Measured: 1 month
Assessment of pulp vitality
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Measured: 3 months
Assessment of pulp vitality
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Measured: 6 months
Assessment of pulp vitality
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Measured: 12 months
Assessment of root development
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Measured: 1 month
Assessment of root development
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Measured: 3 months
Assessment of root development
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Measured: 6 months
Assessment of root development
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Measured: 12 months
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using the periapical index score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
Measured: 1 month
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Measured: 1 month
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
Measured: 3 months
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Measured: 3 months
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
Measured: 6 months
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Measured: 6 months
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
Measured: 12 months
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
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 posted18 May 2020
- Study start6 Jul 2018
- Primary completion20 Jan 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Mahmoud MS Hassan, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptMohamed Ibrahim, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptSybel M Moussa, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptNihal A Lehita, PhD, Study chair, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390854
- Sponsor's protocol ID
- blood clot/ PRF & regeneration
- Status last verified
- Nov 2020
- First submitted
- 8 May 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bakhtiar H, Vatanpour M, Rayani A, Navi F, Asna-Ashari E, Ahmadi A, Jafarzadeh H. The plasma-rich in growth factor as a suitable matrix in regenerative endodontics: a case series. N Y State Dent J. 2014 Jun-Jul;80(4):49-53.
PubMed 25219066Keswani D, Pandey RK. Revascularization of an immature tooth with a necrotic pulp using platelet-rich fibrin: a case report. Int Endod J. 2013 Nov;46(11):1096-104. doi: 10.1111/iej.12107. Epub 2013 Apr 13.
PubMed 23581794Yassen GH, Eckert GJ, Platt JA. Effect of intracanal medicaments used in endodontic regeneration procedures on microhardness and chemical structure of dentin. Restor Dent Endod. 2015 May;40(2):104-12. doi: 10.5395/rde.2015.40.2.104. Epub 2014 Dec 24.
PubMed 25984471Yassen GH, Sabrah AH, Eckert GJ, Platt JA. Effect of different endodontic regeneration protocols on wettability, roughness, and chemical composition of surface dentin. J Endod. 2015 Jun;41(6):956-60. doi: 10.1016/j.joen.2015.02.023. Epub 2015 Mar 29.
PubMed 25823403Neha K, Kansal R, Garg P, Joshi R, Garg D, Grover HS. Management of immature teeth by dentin-pulp regeneration: a recent approach. Med Oral Patol Oral Cir Bucal. 2011 Nov 1;16(7):e997-1004. doi: 10.4317/medoral.17187.
PubMed 21743418Lovelace TW, Henry MA, Hargreaves KM, Diogenes A. Evaluation of the delivery of mesenchymal stem cells into the root canal space of necrotic immature teeth after clinical regenerative endodontic procedure. J Endod. 2011 Feb;37(2):133-8. doi: 10.1016/j.joen.2010.10.009.
PubMed 21238791Cotti E, Mereu M, Lusso D. Regenerative treatment of an immature, traumatized tooth with apical periodontitis: report of a case. J Endod. 2008 May;34(5):611-6. doi: 10.1016/j.joen.2008.02.029.
PubMed 18436046Cehreli ZC, Isbitiren B, Sara S, Erbas G. Regenerative endodontic treatment (revascularization) of immature necrotic molars medicated with calcium hydroxide: a case series. J Endod. 2011 Sep;37(9):1327-30. doi: 10.1016/j.joen.2011.05.033. Epub 2011 Jul 13.
PubMed 21846559Law AS. Considerations for regeneration procedures. J Endod. 2013 Mar;39(3 Suppl):S44-56. doi: 10.1016/j.joen.2012.11.019.
PubMed 23439044
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04390854
- Acronym / sponsor ID
- blood clot/ PRF & regeneration
- Conditions
- Pulp Necroses
- Keywords
- Regenerative endodontics, Open apex, Immature necrotic teeth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 18 May 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.
The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.
Detailed description
30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induced blood clot scaffold | Active comparator | Biological: Blood clot scaffold |
| Induced blood clot scaffold combined with Platelet rich fibrin | Experimental | Biological: Blood clot scaffold combined with PRF |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Necrotic incisors with immature roots
- Pulp space not needed for post and core.
- The patient has to be free from any coagulation disorders, with normal platelets count.
- Good oral hygiene
- Cooperative patient
Key exclusion criteria (5 listed)
- Internal or external root resorption.
- Root fracture and/or alveolar fracture.
- Previous root canal treatment.
- Medically compromised patients
- Uncooperative patient
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 |
|---|---|---|
| Blood clot scaffoldBleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction. Biodentine will be placed approximately 3-4 mm below the cementoenamel junction. | Biological | Induced blood clot scaffold |
| Blood clot scaffold combined with PRFPlatelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge** at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold. | Biological | Induced blood clot scaffold combined with Platelet rich fibrin |
Primary outcome
Subjective pain assessment
Time frame: 1 month
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Subjective pain assessment
Time frame: 3 months
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Subjective pain assessment
Time frame: 6 months
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Subjective pain assessment
Time frame: 12 months
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Assessment of pulp vitality
Time frame: 1 month
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of pulp vitality
Time frame: 3 months
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of pulp vitality
Time frame: 6 months
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of pulp vitality
Time frame: 12 months
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of root development
Time frame: 1 month
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of root development
Time frame: 3 months
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of root development
Time frame: 6 months
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of root development
Time frame: 12 months
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of the size of periapical radiolucency
Time frame: 1 month
Size of the lesion will be assessed using the periapical index score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
Assessment of the size of periapical radiolucency
Time frame: 1 month
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Assessment of the size of periapical radiolucency
Time frame: 3 months
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
Assessment of the size of periapical radiolucency
Time frame: 3 months
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Assessment of the size of periapical radiolucency
Time frame: 6 months
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
Assessment of the size of periapical radiolucency
Time frame: 6 months
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Assessment of the size of periapical radiolucency
Time frame: 12 months
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
Assessment of the size of periapical radiolucency
Time frame: 12 months
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
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 4 Nov 2020.
- Background: PubMed 25219066Bakhtiar H, Vatanpour M, Rayani A, Navi F, Asna-Ashari E, Ahmadi A, Jafarzadeh H. The plasma-rich in growth factor as a suitable matrix in regenerative endodontics: a case series. N Y State Dent J. 2014 Jun-Jul;80(4):49-53.
- Background: PubMed 23581794Keswani D, Pandey RK. Revascularization of an immature tooth with a necrotic pulp using platelet-rich fibrin: a case report. Int Endod J. 2013 Nov;46(11):1096-104. doi: 10.1111/iej.12107. Epub 2013 Apr 13.
- Background: PubMed 25984471Yassen GH, Eckert GJ, Platt JA. Effect of intracanal medicaments used in endodontic regeneration procedures on microhardness and chemical structure of dentin. Restor Dent Endod. 2015 May;40(2):104-12. doi: 10.5395/rde.2015.40.2.104. Epub 2014 Dec 24.
- Background: PubMed 25823403Yassen GH, Sabrah AH, Eckert GJ, Platt JA. Effect of different endodontic regeneration protocols on wettability, roughness, and chemical composition of surface dentin. J Endod. 2015 Jun;41(6):956-60. doi: 10.1016/j.joen.2015.02.023. Epub 2015 Mar 29.
- Background: PubMed 21743418Neha K, Kansal R, Garg P, Joshi R, Garg D, Grover HS. Management of immature teeth by dentin-pulp regeneration: a recent approach. Med Oral Patol Oral Cir Bucal. 2011 Nov 1;16(7):e997-1004. doi: 10.4317/medoral.17187.
- Background: PubMed 21238791Lovelace TW, Henry MA, Hargreaves KM, Diogenes A. Evaluation of the delivery of mesenchymal stem cells into the root canal space of necrotic immature teeth after clinical regenerative endodontic procedure. J Endod. 2011 Feb;37(2):133-8. doi: 10.1016/j.joen.2010.10.009.
- Background: PubMed 18436046Cotti E, Mereu M, Lusso D. Regenerative treatment of an immature, traumatized tooth with apical periodontitis: report of a case. J Endod. 2008 May;34(5):611-6. doi: 10.1016/j.joen.2008.02.029.
- Background: PubMed 21846559Cehreli ZC, Isbitiren B, Sara S, Erbas G. Regenerative endodontic treatment (revascularization) of immature necrotic molars medicated with calcium hydroxide: a case series. J Endod. 2011 Sep;37(9):1327-30. doi: 10.1016/j.joen.2011.05.033. Epub 2011 Jul 13.
- Background: PubMed 23439044Law AS. Considerations for regeneration procedures. J Endod. 2013 Mar;39(3 Suppl):S44-56. doi: 10.1016/j.joen.2012.11.019.
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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.
Mahmoud MS Hassan, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Mohamed Ibrahim, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Sybel M Moussa, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blood clot scaffold and Blood clot scaffold combined with PRF in people with Pulp Necroses, run by Nourhan M.Aly 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 5 inclusion and 5 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 4 Nov 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Subjective pain assessment (time frame: 1 month). The study lists 20 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 NCT04390854, which also lists 9 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 4 Nov 2020.