Root ResorptionNCT04410679
Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque
A study testing injectable PRF in people with Root Resorption, run by Fayoum University at 1 site in Egypt.
Trial summary
Currently Endodontics looks forward for regeneration rather than repair. Regenerative endodontic therapy was limited to pulp revascularization of necrotic pulp in immature teeth , followed by mature teeth. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Resorption
- What is being tested?
- injectable PRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2018to 2 May 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 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients 13-30 years old
- no sex predilection
- medically free
- Suffering from internal inflammatory root resorption in permanent anterior mature teeth
- associated with or without periapical radiolucency
- no or grade I tooth mobility, and a pocket depth <3 mm
Who cannot join
- old age
- Medically medically compromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technique: A Clinical Study With Cone Beam Computed Tomography Evaluation
Currently Endodontics looks forward for regeneration rather than repair. Regenerative endodontic therapy was limited to pulp revascularization of necrotic pulp in immature teeth , followed by mature teeth. Recently pulp revascularization technique by induction of blood clot was applied in the treatment of inflammatory root resorption. So far, no clinical study for management of teeth with inflammatory internal root resorption by using injectable PRF revascularization has been described in the literature. Thus, this is the first clinical attempt to manage inflammatory root resorption in necrotic incisor teeth using injectable PRF regenerative approach.
Read the detailed description
13 teeth in a total of 10 patients with inflammatory root resorption will be treated using revascualrization technique, iPRF will be prepared and unjected in the canal after previous canal disinfection with calcium hydroxide for 2-4 weeks. cBCT will be taken preoperative and 12 month follow up period, also clinical and radiographic follow uo will be considered every 3 months for 1 year.
- Conditions
- Root Resorption
- Being tested
- injectable PRF
- Keywords
- Pulp revascularization, injectable Platelet rich fibrin, i-PRF, root resorption, CBCT
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable PRFBiological
blood sample and centrifuged to obtain i-PRF
| Study group | Role | What they receive |
|---|---|---|
| injectabl PRF for treatment of internal root resorption | Experimental | Not described Receives: Biological: injectable PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in volumetric size of internal root resorption lesions
Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT
Measured: 12 months
Secondary outcomes (1)
change in volumetric size of periapical lesions
Measuring volumetric dimensions of periapical lesion pre and postoperatively using 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 posted1 Jun 2020
- Study start3 Jun 2018
- Primary completion6 Jun 2019
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root ResorptionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Nageh, Fayoum University
- Investigators
- Mohamed Nageh, Lecturer, Principal investigator, Faculty of dentistry, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410679
- Sponsor's protocol ID
- FayoumU
- Status last verified
- Oct 2021
- First submitted
- 27 May 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technique: A Clinical Study With Cone Beam Computed Tomography Evaluation
- ClinicalTrials.gov ID
- NCT04410679
- Acronym / sponsor ID
- FayoumU
- Conditions
- Root Resorption
- Keywords
- Pulp revascularization, injectable Platelet rich fibrin, i-PRF, root resorption, CBCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 3 Jun 2018 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 1 Jun 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.
Currently Endodontics looks forward for regeneration rather than repair. Regenerative endodontic therapy was limited to pulp revascularization of necrotic pulp in immature teeth , followed by mature teeth. Recently pulp revascularization technique by induction of blood clot was applied in the treatment of inflammatory root resorption. So far, no clinical study for management of teeth with inflammatory internal root resorption by using injectable PRF revascularization has been described in the literature. Thus, this is the first clinical attempt to manage inflammatory root resorption in necrotic incisor teeth using injectable PRF regenerative approach.
Detailed description
13 teeth in a total of 10 patients with inflammatory root resorption will be treated using revascualrization technique, iPRF will be prepared and unjected in the canal after previous canal disinfection with calcium hydroxide for 2-4 weeks. cBCT will be taken preoperative and 12 month follow up period, also clinical and radiographic follow uo will be considered every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| injectabl PRF for treatment of internal root resorption | Experimental | Biological: injectable PRF |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- patients 13-30 years old
- no sex predilection
- medically free
- Suffering from internal inflammatory root resorption in permanent anterior mature teeth
- associated with or without periapical radiolucency
Key exclusion criteria (2 listed)
- old age
- Medically medically compromised patients
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 |
|---|---|---|
| injectable PRFblood sample and centrifuged to obtain i-PRF | Biological | injectabl PRF for treatment of internal root resorption |
Primary outcome
change in volumetric size of internal root resorption lesions
Time frame: 12 months
Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT
1 secondary outcome
change in volumetric size of periapical lesions
Time frame: 12 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 8 Oct 2021.
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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.
Mohamed Nageh, Lecturer principal investigator
Faculty of dentistry, Fayoum 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 injectable PRF in people with Root Resorption, run by Fayoum University 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 6 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 8 Oct 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 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.
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?
change in volumetric size of internal root resorption lesions (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 8 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.