To Evaluate the Clinical and Radiographic Effect of Platelet-rich Fibrin in Treatment of Necrotic Permanent Teeth with Open ApicesPhase 3NCT06693349
Evaluation of Platelet-rich Fibrin for Revascularization of Immature Permanent Teeth Versus Standard Apexification
A Phase 3 study testing the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth and the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth in people with To Evaluate the Clinical and Radiographic Effect of Platelet-rich Fibrin in Treatment of Necrotic Permanent Teeth with Open Apices, run by Mohammed Nasser Alhajj at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the effect of platelet-rich fibrin for revascularization of immature permanent teeth in comparison to standard apexification using calcium hydroxide (as a 12 months follow up for previous study) through using clinical outcomes and radiographically using cone beam computed… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- To Evaluate the Clinical and Radiographic Effect of Platelet-rich Fibrin in Treatment of Necrotic Permanent Teeth with Open Apices
- What is being tested?
- the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth and the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2020to 12 Apr 2021
- Phase
- Phase 3
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Patients were free of chronic systemic diseases.
- Clinically, a negative response to electric pulp sensibility testing confirmed the pres-ence of immature necrotic permanent teeth.
- Teeth were categorized as uncontaminated if, during the examination, there were no signs of pain, no tenderness during apical percussion, no tenderness of adjacent soft tissues, and no history of open sinus, fistula or swelling.
- Radiographically, teeth were with roots exhibiting thin dentin walls and open apical foramina larger than 1 mm, along with apical periodontitis (considered as contami-nated) or without apical periodontitis (considered as uncontaminated).
Who cannot join
- other than inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Platelet-rich Fibrin for Revascularization of Im-mature Permanent Teeth Versus Standard Apexification: a 12-month Clinical Follow-up Study
The goal of this clinical trial is to evaluate the effect of platelet-rich fibrin for revascularization of immature permanent teeth in comparison to standard apexification using calcium hydroxide (as a 12 months follow up for previous study) through using clinical outcomes and radiographically using cone beam computed tomography the main questions it aims to answer are
- is the platelet-rich fibrin an effective mean for management of necrotic immature permanent teeth
- is the platelet-rich fibrin has a superior clinical and radiographic effects than calcium hydroxide apexification participants were treated either by platelet-rich fibrin revascularisation or calcium hydroxide apexification
Read the detailed description
This study is an extension of a previous study [12], encompassing a 12-month fol-low-up period. The protocol for this study received approval from the ethical committee of the Faculty of Dentistry at Mansoura University (11111218) as a randomized con-trolled-clinical trial with a 1:1 allocation ratio for groups and subgroups. The sample size for this study was calculated based on Nagy et al.'s study [13], which determined a re-quired sample size of 28 teeth.
Inclusion and diagnostic criteria:
A total of 28 children, including both boys and girls, were recruited through daily pa-tient screenings in the Clinics of Pediatric Dentistry and dental public health department, Faculty of Dentistry at Mansoura University, following specific inclusion and diagnostic criteria:
- Patients were free of chronic systemic diseases.
- Clinically, a negative response to electric pulp sensibility testing confirmed the pres-ence of immature necrotic permanent teeth.
- Teeth were categorized as uncontaminated if, during the examination, there were no signs of pain, no tenderness during apical percussion, no tenderness of adjacent soft tissues, and no history of open sinus, fistula or swelling.
- Radiographically, teeth were with roots exhibiting thin dentin walls and open apical foramina larger than 1 mm, along with apical periodontitis (considered as contami-nated) or without apical periodontitis (considered as uncontaminated).
Patients' allocation:
The included 28 children were divided into two main groups, each consisting of 14 children: Group I (contaminated teeth) and Group II (uncontaminated teeth). Within each group, children were further divided into two subgroups based on the treatment tech-nique. The allocation was determined through simple randomization, resulting in a Platelet-Rich Fibrin subgroup (n=7 for each) and a Calcium Hydroxide (CH) apexification subgroups (control) (n=7 for each),
- Being tested
- the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth, the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth
- Keywords
- platelet-rich fibrin, revascularization, apexification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teethDrug
Also called platelet-rich fibrin revascularization
this procedure was anticipated to give superior effects than other procedure used in this study
the effect of apexification in treatment of contaminated and uncontaminated immature permanent teethDrug
Also called calcium hydroxide apexification
this procedure was anticipated to be replaced by other procedure be used in this study
| Study group | Role | What they receive |
|---|---|---|
| Contaminated immature permanent teeth | Active comparator | treatment of contaminated immature permanent teeth through either revascularization or apexification procedures Receives: Drug: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth; Drug: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth |
| uncontaminated immature permanent teeth | Active comparator | treatment of uncontaminated immature permanent teeth through either revascularization or apexification procedures Receives: Drug: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth; Drug: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic measurements of the change in the canal space
Radiographic measurements of the change in the canal space, including an increase in root length and thickness, and reduction in a diameter of the apical foramen, were conducted using the CBCT
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start2 Jan 2020
- Primary completion20 Feb 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Clinical and Radiographic Effect of Platelet-rich Fibrin in Treatment of Necrotic Permanent Teeth with Open ApicesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Nasser Alhajj
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor-investigator, Mohammed Nasser Alhajj, Thamar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693349
- Sponsor's protocol ID
- 11111218
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet-rich Fibrin for Revascularization of Im-mature Permanent Teeth Versus Standard Apexification: a 12-month Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT06693349
- Acronym / sponsor ID
- 11111218
- Keywords
- platelet-rich fibrin, revascularization, apexification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mohammed Nasser AlhajjUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 18 Nov 2024 (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 goal of this clinical trial is to evaluate the effect of platelet-rich fibrin for revascularization of immature permanent teeth in comparison to standard apexification using calcium hydroxide (as a 12 months follow up for previous study) through using clinical outcomes and radiographically using cone beam computed tomography the main questions it aims to answer are
- is the platelet-rich fibrin an effective mean for management of necrotic immature permanent teeth
- is the platelet-rich fibrin has a superior clinical and radiographic effects than calcium hydroxide apexification participants were treated either by platelet-rich fibrin revascularisation or calcium hydroxide apexification
Detailed description
This study is an extension of a previous study [12], encompassing a 12-month fol-low-up period. The protocol for this study received approval from the ethical committee of the Faculty of Dentistry at Mansoura University (11111218) as a randomized con-trolled-clinical trial with a 1:1 allocation ratio for groups and subgroups. The sample size for this study was calculated based on Nagy et al.'s study [13], which determined a re-quired sample size of 28 teeth.
Inclusion and diagnostic criteria:
A total of 28 children, including both boys and girls, were recruited through daily pa-tient screenings in the Clinics of Pediatric Dentistry and dental public health department, Faculty of Dentistry at Mansoura University, following specific inclusion and diagnostic criteria:
- Patients were free of chronic systemic diseases.
- Clinically, a negative response to electric pulp sensibility testing confirmed the pres-ence of immature necrotic permanent teeth.
- Teeth were categorized as uncontaminated if, during the examination, there were no signs of pain, no tenderness during apical percussion, no tenderness of adjacent soft tissues, and no history of open sinus, fistula or swelling.
- Radiographically, teeth were with roots exhibiting thin dentin walls and open apical foramina larger than 1 mm, along with apical periodontitis (considered as contami-nated) or without apical periodontitis (considered as uncontaminated).
Patients' allocation:
The included 28 children were divided into two main groups, each consisting of 14 children: Group I (contaminated teeth) and Group II (uncontaminated teeth). Within each group, children were further divided into two subgroups based on the treatment tech-nique. The allocation was determined through simple randomization, resulting in a Platelet-Rich Fibrin subgroup (n=7 for each) and a Calcium Hydroxide (CH) apexification subgroups (control) (n=7 for each),
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contaminated immature permanent teeth | Active comparator | Drug: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth, Drug: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teethtreatment of contaminated immature permanent teeth through either revascularization or apexification procedures |
| uncontaminated immature permanent teeth | Active comparator | Drug: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth, Drug: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teethtreatment of uncontaminated immature permanent teeth through either revascularization or apexification procedures |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Patients were free of chronic systemic diseases.
Key exclusion criteria (1 listed)
- other than inclusion criteria
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 |
|---|---|---|
| the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teethAlso: platelet-rich fibrin revascularizationthis procedure was anticipated to give superior effects than other procedure used in this study | Drug | Contaminated immature permanent teeth, uncontaminated immature permanent teeth |
| the effect of apexification in treatment of contaminated and uncontaminated immature permanent teethAlso: calcium hydroxide apexificationthis procedure was anticipated to be replaced by other procedure be used in this study | Drug | Contaminated immature permanent teeth, uncontaminated immature permanent teeth |
Primary outcome
Radiographic measurements of the change in the canal space
Time frame: 16 months
Radiographic measurements of the change in the canal space, including an increase in root length and thickness, and reduction in a diameter of the apical foramen, were conducted using the 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 18 Nov 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth and the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth in people with To Evaluate the Clinical and Radiographic Effect of Platelet-rich Fibrin in Treatment of Necrotic Permanent Teeth with Open Apices, run by Mohammed Nasser Alhajj 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 4 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 18 Nov 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Radiographic measurements of the change in the canal space (time frame: 16 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 18 Nov 2024.