Periapical PeriodontitisNCT02801552
Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF
A study testing PRF in people with Periapical Periodontitis and Tooth Diseases, run by Fujian Medical University at 1 site in China.
Trial summary
This study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis, Tooth Diseases, Stomatognathic Diseases
- What is being tested?
- PRF
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Feb 2020
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between 6 and 18 years of age
- Provision of Informed Consent
- Cooperative in the dental chair
- Permanent immature teeth with apical periodontitis and incomplete root development
Who cannot join
- Have a medical history that may complicate treatment
- Unlikely to be able to comply with the study procedures
Trial locations and contacts
1 site in 1 country.
China1 site
School and Hospital of Stomatology, Fujian Medical University
Fuzhou, Fujian, 350002
About this study
Official title: Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using Platelet-rich Fibrin : A Pilot Randomized Controlled Trial
This study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative endodontic procedure.
Read the detailed description
The conventional method of regenerative endodontic procedure using a blood clot as scaffold materials has shown successful results. However, it is very difficult to induce bleeding and place mineral trioxide aggregate over a blood clot. Platelet-rich fibrin (PRF), a second-generation platelet concentrate. PRF is a matrix of autologous fibrin containing a large quantity of platelets, growth factors and leukocytes. PRF preparation technique is very simple, inexpensive and doesn't require any chemical agents. The purpose of this study is to test the hypothesis that the use of PRF in regenerative endodontic procedure of immature permanent teeth with apical periodontitis will accelerate periapical bone healing and stimulate the root maturation.
- Being tested
- PRF
- Keywords
- regenerative endodontic treatment, platelet-rich fibrin, Immature permanent tooth, apical periodontitis
- Medical subject headings
- Periapical Periodontitis, Tooth Diseases, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFDevice
Also called mineral trioxide aggregate
Regenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist.
| Study group | Role | What they receive |
|---|---|---|
| Regenerative Endodontic Procedure + PRF | Experimental | Visit 1: root canal dressing with triple antibiotic paste. Visit 2: a 5 ml sample of whole blood was drawn intravenously from the patient's forearm. The blood sample is centrifuged at 400 g for 10 min. The prepared PRF membrane is cut into segments, the fragments are placed into the canal space. The coronal is sealed mineral trioxide aggregate and composite resin. Receives: Device: PRF |
| Regenerative Endodontic Procedure | No intervention | Regenerative Endodontic Procedure Visit 1: root canal dressing with triple antibiotic paste. Visit 2: Blood clot formation is induced in the root canal after disinfection. No PRF was used in this group. Then the canal access is sealed with mineral trioxide aggregate and composite resin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of periapical healing
Measured: 12 months
Secondary outcomes (2)
Evidence of root development
Measured: 24 months
Evidence of pulp sensibility
a positive response to pulp sensibility tests include cold test and electric pulp testing
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojing Huang, Fujian Medical University
- Investigators
- Xiaojing Huang, PhD, Study chair, School and Hospital of Stomatology, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801552
- Sponsor's protocol ID
- JS14031
- Status last verified
- Sep 2021
- First submitted
- 12 Jun 2016
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using Platelet-rich Fibrin : A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02801552
- Acronym / sponsor ID
- JS14031
- Keywords
- regenerative endodontic treatment, platelet-rich fibrin, Immature permanent tooth, apical periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 16 Jun 2016 (estimated)
- 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 study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative endodontic procedure.
Detailed description
The conventional method of regenerative endodontic procedure using a blood clot as scaffold materials has shown successful results. However, it is very difficult to induce bleeding and place mineral trioxide aggregate over a blood clot. Platelet-rich fibrin (PRF), a second-generation platelet concentrate. PRF is a matrix of autologous fibrin containing a large quantity of platelets, growth factors and leukocytes. PRF preparation technique is very simple, inexpensive and doesn't require any chemical agents. The purpose of this study is to test the hypothesis that the use of PRF in regenerative endodontic procedure of immature permanent teeth with apical periodontitis will accelerate periapical bone healing and stimulate the root maturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenerative Endodontic Procedure + PRF | Experimental | Device: PRFVisit 1: root canal dressing with triple antibiotic paste. Visit 2: a 5 ml sample of whole blood was drawn intravenously from the patient's forearm. The blood sample is centrifuged at 400 g for 10 min. The prepared PRF membrane is cut into segments, the fragments are placed into the canal space. The coronal is sealed mineral trioxide aggregate and composite resin. |
| Regenerative Endodontic Procedure | No intervention | –Regenerative Endodontic Procedure Visit 1: root canal dressing with triple antibiotic paste. Visit 2: Blood clot formation is induced in the root canal after disinfection. No PRF was used in this group. Then the canal access is sealed with mineral trioxide aggregate and composite resin. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between 6 and 18 years of age
- Provision of Informed Consent
- Cooperative in the dental chair
- Permanent immature teeth with apical periodontitis and incomplete root development
Key exclusion criteria (2 listed)
- Have a medical history that may complicate treatment
- Unlikely to be able to comply with the study procedures
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 |
|---|---|---|
| PRFAlso: mineral trioxide aggregateRegenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist. | Device | Regenerative Endodontic Procedure + PRF |
Primary outcome
Evidence of periapical healing
Time frame: 12 months
2 secondary outcomes
Evidence of root development
Time frame: 24 months
Evidence of pulp sensibility
Time frame: 24 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 5 Sep 2021.
- 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.
Xiaojing Huang, PhD study chair
School and Hospital of Stomatology, Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF in people with Periapical Periodontitis and Tooth Diseases, run by Fujian Medical University at 1 site in China.
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: finished, as of the sponsor's last update on 5 Sep 2021. 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 China. 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?
Evidence of periapical healing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2021.