Regenerative EndodonticsNCT07119619
Clinical and Radiographic Outcomes of PRF, Chitosan, and Blood Clot in Regenerative Endodontics of Molars
A study testing Regenerative Endodontic Treatment Using a Blood Clot as a Scaffold, Regenerative Endodontic Treatment Using a Chitosan as a Scaffold and Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a Scaffold in people with Regenerative Endodontics, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aimed to evaluate the long-term effects of using chitosan, blood clots, and platelet-rich fibrin as scaffolds in regenerative endodontics on tooth development. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Regenerative Endodontics
- What is being tested?
- Regenerative Endodontic Treatment Using a Blood Clot as a Scaffold, Regenerative Endodontic Treatment Using a Chitosan as a Scaffold and Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a Scaffold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2022to 20 Aug 2024
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient Selection Criteria
- Being between the ages of 6-14
- Not having any systemic disease
- Not using any regular medication
- Not having any detected allergies
- The patient must be able to cooperate to the extent that the treatment can be applied healthily
- The patient's guardian must agree to participate in the study
- Selection Criteria of Teeth • Restorable necrotic immature first and second permanent mandibular molars with two roots and a root development stage of 3 or 4 according to Cvek's classification
Who cannot join
- Failure to meet the patient and tooth selection criteria mentioned above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical and Radiographic Success of Platelet-Rich Fibrin, Chitosan, and Blood Clot as Scaffolds in Regenerative Endodontic Treatment of Molars
This clinical trial aimed to evaluate the long-term effects of using chitosan, blood clots, and platelet-rich fibrin as scaffolds in regenerative endodontics on tooth development. The trial aimed to answer the following questions:
Does chitosan shorten the duration of treatment for participants? Does chitosan promote root development? Which scaffold is most effective for root development? Which scaffold is more practical and effective to use in pediatric patients? Participants underwent regenerative endodontic treatment and were called to the clinic every six months for symptom assessment. Clinical and radiographic records were kept.
Read the detailed description
Regenerative endodontic treatments are biologically based procedures designed to physiologically replace damaged tooth structures, including the cells of the pulp-dentin complex. The aim of this treatment is to promote normal root development in immature permanent teeth with necrotic pulp.The primary goal of regenerative endodontics is to stimulate stem cells and encourage their division and proliferation to regenerate damaged tissue. However, a scaffold is essential for the survival of stem cells throughout the regeneration process. A key component of this process is the presence of a scaffold that allows stem cells from the apical papilla to adhere, proliferate, and differentiate. Blood clots and platelet-rich fibrin are frequently used as scaffolds in regenerative endodontics. However, research is ongoing to determine the appropriate scaffold for cases where these are not applicable.Researchers investigated an alternative scaffold for children who could not achieve apical bleeding or allow blood collection from the arm for PRF. Due to its biocompatibility, low cost, and broad-spectrum antibacterial activity, chitosan was included as the third group in this study. The immature necrotic molars to be treated were randomly divided into three groups. Regenerative endodontic treatment was performed using three different scaffolds: blood clot, PRF, and chitosan. The results were evaluated radiographically and clinically.
- Conditions
- Regenerative Endodontics
- Being tested
- Regenerative Endodontic Treatment Using a Blood Clot as a Scaffold, Regenerative Endodontic Treatment Using a Chitosan as a Scaffold, Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a Scaffold
- Keywords
- Bllod clot, Chitosan, PRF, Regenerative endodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontic Treatment Using a Blood Clot as a ScaffoldProcedure or surgery
During the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material.The patient has been scheduled for a follow-up appointment within one to four weeks. During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points. Bleeding was induced by instrumentation with a K-type file, at 2 mm past the apical foramen, thus creating a blood clot within the canal. MTA was applied on the scaffold as capping material.
Regenerative Endodontic Treatment Using a Chitosan as a ScaffoldProcedure or surgery
During the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material. The patient has been scheduled for a follow-up appointment within one to four weeks.
During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points.Chitosan in gel form was placed into the root canal space with the help of an injector.MTA was applied on the scaffold as capping material.
Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a ScaffoldProcedure or surgery
During the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material.The patient has been scheduled for a follow-up appointment within one to four weeks. During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points.Ten milliliters of venous blood was collected from the patient and immediately placed in a centrifuge at 3000 rpm for 10 minutes. The prepared PRF was placed in the canal space. MTA was applied on the scaffold as capping material.
| Study group | Role | What they receive |
|---|---|---|
| Chitosan | Other | Not described Receives: Procedure: Regenerative Endodontic Treatment Using a Chitosan as a Scaffold |
| Platelet-rich fibrin | Other | Not described Receives: Procedure: Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a Scaffold |
| Blood clot | Other | Not described Receives: Procedure: Regenerative Endodontic Treatment Using a Blood Clot as a Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic measurements of teeth treated with regenerative endodontic treatment
Root length and thickness (millimeters)
Measured: Baseline and through study completion, an average of 18 months
Radiographic measurements of teeth treated with regenerative endodontic treatment
Evaluation of root maturation (Cvek score; with a minimum of 1 and a maximum of 5, higher scores mean a better result)
Measured: Baseline and through study completion, an average of 18 months
Secondary outcomes (1)
Radiographic measurements of teeth treated with regenerative endodontic treatment
Periapical healing (Periapical index; with a minimum of 1 and a maximum of 5, lower scores mean a better result)
Measured: Baseline and through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start10 Feb 2022
- Primary completion19 Mar 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Regenerative EndodonticsStudies of the same condition, open and under way.
- More trials run by Inonu 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Sandal, Inonu University
- Investigators
- Beyza Sandal, Study chair, Derince Oral and Dental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119619
- Sponsor's protocol ID
- 2022/64
- Other IDs
- TDH-2023-3161
- Status last verified
- Aug 2025
- First submitted
- 29 Jun 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cehreli 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 21846559Ulusoy AT, Turedi I, Cimen M, Cehreli ZC. Evaluation of Blood Clot, Platelet-rich Plasma, Platelet-rich Fibrin, and Platelet Pellet as Scaffolds in Regenerative Endodontic Treatment: A Prospective Randomized Trial. J Endod. 2019 May;45(5):560-566. doi: 10.1016/j.joen.2019.02.002. Epub 2019 Mar 30.
PubMed 30935618
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Radiographic Success of Platelet-Rich Fibrin, Chitosan, and Blood Clot as Scaffolds in Regenerative Endodontic Treatment of Molars
- ClinicalTrials.gov ID
- NCT07119619
- Acronym / sponsor ID
- 2022/64
- Conditions
- Regenerative Endodontics
- Keywords
- Bllod clot, Chitosan, PRF, Regenerative endodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 13 Aug 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 clinical trial aimed to evaluate the long-term effects of using chitosan, blood clots, and platelet-rich fibrin as scaffolds in regenerative endodontics on tooth development. The trial aimed to answer the following questions:
Does chitosan shorten the duration of treatment for participants? Does chitosan promote root development? Which scaffold is most effective for root development? Which scaffold is more practical and effective to use in pediatric patients? Participants underwent regenerative endodontic treatment and were called to the clinic every six months for symptom assessment. Clinical and radiographic records were kept.
Detailed description
Regenerative endodontic treatments are biologically based procedures designed to physiologically replace damaged tooth structures, including the cells of the pulp-dentin complex. The aim of this treatment is to promote normal root development in immature permanent teeth with necrotic pulp.The primary goal of regenerative endodontics is to stimulate stem cells and encourage their division and proliferation to regenerate damaged tissue. However, a scaffold is essential for the survival of stem cells throughout the regeneration process. A key component of this process is the presence of a scaffold that allows stem cells from the apical papilla to adhere, proliferate, and differentiate. Blood clots and platelet-rich fibrin are frequently used as scaffolds in regenerative endodontics. However, research is ongoing to determine the appropriate scaffold for cases where these are not applicable.Researchers investigated an alternative scaffold for children who could not achieve apical bleeding or allow blood collection from the arm for PRF. Due to its biocompatibility, low cost, and broad-spectrum antibacterial activity, chitosan was included as the third group in this study. The immature necrotic molars to be treated were randomly divided into three groups. Regenerative endodontic treatment was performed using three different scaffolds: blood clot, PRF, and chitosan. The results were evaluated radiographically and clinically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chitosan | Other | Procedure: Regenerative Endodontic Treatment Using a Chitosan as a Scaffold |
| Platelet-rich fibrin | Other | Procedure: Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a Scaffold |
| Blood clot | Other | Procedure: Regenerative Endodontic Treatment Using a Blood Clot as a Scaffold |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patient Selection Criteria
- Being between the ages of 6-14
- Not having any systemic disease
- Not using any regular medication
- Not having any detected allergies
Key exclusion criteria (1 listed)
- Failure to meet the patient and tooth selection criteria mentioned above
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 |
|---|---|---|
| Regenerative Endodontic Treatment Using a Blood Clot as a ScaffoldDuring the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material.The patient has been scheduled for a follow-up appointment within one to four weeks. During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points. Bleeding was induced by instrumentation with a K-type file, at 2 mm past the apical foramen, thus creating a blood clot within the canal. MTA was applied on the scaffold as capping material. | Procedure or surgery | Blood clot |
| Regenerative Endodontic Treatment Using a Chitosan as a ScaffoldDuring the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material. The patient has been scheduled for a follow-up appointment within one to four weeks. During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points.Chitosan in gel form was placed into the root canal space with the help of an injector.MTA was applied on the scaffold as capping material. | Procedure or surgery | Chitosan |
| Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a ScaffoldDuring the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material.The patient has been scheduled for a follow-up appointment within one to four weeks. During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points.Ten milliliters of venous blood was collected from the patient and immediately placed in a centrifuge at 3000 rpm for 10 minutes. The prepared PRF was placed in the canal space. MTA was applied on the scaffold as capping material. | Procedure or surgery | Platelet-rich fibrin |
Primary outcome
Radiographic measurements of teeth treated with regenerative endodontic treatment
Time frame: Baseline and through study completion, an average of 18 months
Root length and thickness (millimeters)
Radiographic measurements of teeth treated with regenerative endodontic treatment
Time frame: Baseline and through study completion, an average of 18 months
Evaluation of root maturation (Cvek score; with a minimum of 1 and a maximum of 5, higher scores mean a better result)
1 secondary outcome
Radiographic measurements of teeth treated with regenerative endodontic treatment
Time frame: Baseline and through study completion, an average of 18 months
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 13 Aug 2025.
- 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 30935618Ulusoy AT, Turedi I, Cimen M, Cehreli ZC. Evaluation of Blood Clot, Platelet-rich Plasma, Platelet-rich Fibrin, and Platelet Pellet as Scaffolds in Regenerative Endodontic Treatment: A Prospective Randomized Trial. J Endod. 2019 May;45(5):560-566. doi: 10.1016/j.joen.2019.02.002. Epub 2019 Mar 30.
- 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.
Beyza Sandal study chair
Derince Oral and Dental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative Endodontic Treatment Using a Blood Clot as a Scaffold, Regenerative Endodontic Treatment Using a Chitosan as a Scaffold and Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a Scaffold in people with Regenerative Endodontics, run by Inonu University 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 8 inclusion and 1 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 13 Aug 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 measurements of teeth treated with regenerative endodontic treatment (time frame: Baseline and through study completion, an average of 18 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 NCT07119619, which also lists 2 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 13 Aug 2025.