Orthodontic Pathological Resorption of External RootNCT04885842
Efficacy of Injection Platelet-rich Fibrin(I-PRF) in Accelerate Alignment and Leveling
A study testing injection I-PRF in people with Orthodontic Pathological Resorption of External Root, run by Latakia University at 1 site in Syria.
Trial summary
the aim of this study is to evaluate the effectiveness of injection I-PRF to accelerate alignment and leveling of the upper anterior teeth and reduce the time required for treatment. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pathological Resorption of External Root
- What is being tested?
- injection I-PRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSyria
- Study dates
- 14 Sep 2019to 3 Mar 2021
- 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 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The Clinical Diagnosis the age of patients ranges between 16-24 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to Little irregularity index 20,class1 according angel classification,
Who cannot join
- the presence of any systemic disease that affects the orthodontic movement Diabetes , a patient undergoing previous orthodontic treatment, a patient who takes medicines Cortisone,NSAIDs the affect dental movement . and the presence of bleeding disorders Disturbance in the number of platelets.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Injection Platelet-rich Fibrin(I-PRF) in Accelerate Alignment and Leveling in an Adult Sample
the aim of this study is to evaluate the effectiveness of injection I-PRF to accelerate alignment and leveling of the upper anterior teeth and reduce the time required for treatment.
Read the detailed description
What remains the most important and common question for adult patients who want to undergo orthodontic treatment is how long the treatment will take, as the period of orthodontic treatment may take between 18 and 24 months in some cases of malocclusion ,and this may cause discomfort for the patient and reduce cooperation during treatment in addition to the aesthetic problems associated with presence of bracket.
the possibility of an increase of Enamel mineral dissolution and spread of dental caries ,gingival problems and this is due to the increase of the duration of orthodontic treatment.
Orthodontic treatment begins with the leveling and alignment stage and constitutes an important part of the treatment stages, during which the teeth(incisal edges, cusps posterior teeth) are placed on one level and to achieve perfect points of contact between the teeth In some cases of malocclusion especially severe ones, this stage may take about 8 months therefore , the interest of orthodontics has increased in finding new methods and techniques in order to accelerate treatment, Various methods and techniques have been used to accelerate orthodontic treatment Which includes :biomaterial injection, surgical and physical methods. Yet, despite the effectiveness of some of these methods in accelerating dental movement ,each of its disadvantages and side effects on the patient therefore, attention must be paid to anther effective safe and simple non-traumatic method hence the idea of using platelet rich fibrin came.
Platelet rich fibrin is a therapeutic approach and it is a new generation of platelet concentrates Which was introduced to the field of dentistry by choukroun in 2001 who developed this treatment technique.
Platelet rich fibrin injection technology (I-PRF), which is obtained in liquid form for injection has been developed through the concept of reduced speed centrifugation .
PRF is a biomaterial .Autologus is taken from a person's own blood.Unlike PRP, no external bioactive are added to active platelet. Rather, the blood sample remains normal. The importance and therapeutic benefits of platelet-rich fibrin come through the presence of key and other common elements that collectively contribute to the healing processes and regeneration of the soft and bone tissues represented by the presence of fibrin in the form of a matrix with large and significant numbers of leukocytes, cytokines, platelets, in addition to the participation of growth factors which play an important role in the processes of healing.
Platelet rich fibrin is a simple, easy to apply and economical technique that does not require adding any substances to the blood sample as an anticoagulant.
To date, there are no studies on the role that platelet rich fibrin injection can play in accelerating aligning and leveling the upper anterior teeth and reducing the time required for treatments Therefore the aim of study is to verify the effectiveness of injection I-PRF to accelerate alignment and leveling of the upper anterior teeth and reduce the time required for treatment
- Being tested
- injection I-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection I-PRFOther
Also called control Group
injection I-PRF with brackets
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | injection I-PRF with brackets Receives: Other: injection I-PRF |
| Control Group | No intervention | applying brackets only |
What is being measured
The primary outcome is the main question the study is designed to answer.
alignment and leveling Improvement Percentage(ALIP):
Determining the percentage of improvement in alignment and leveling by calculating the value of the change in the Little index in one of the studied time periods (T1) or (T2) or (T3) which is calculated by subtracting the value of the Little index at the studied period of time from the value of the Little index at (T0) When the primary wire is inserted, the value of the little index at (T0) is multiplied by 100 Through the following
Measured: 6 Month
Secondary outcomes (1)
Overall Alignment and Leveling Time
the overall time required to complete the leveling and alignment was calculated by calculating the number of days between (To) and (T3).
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start14 Sep 2019
- Primary completion18 Feb 2021
- Study completion3 Mar 2021
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 Orthodontic Pathological Resorption of External RootStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical study ,two parallel groups design. The research sample consisted of 18 patients (11 famales,7 males)Patients were randomly assigned to 2 groups using the sample randomization principle. Each group included 8 patient (9 control group applying brackets only)(9 group injection I-PRF with brackets).
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885842
- Sponsor's protocol ID
- TishreenU
- Status last verified
- Mar 2021
- First submitted
- 9 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
The gliding path of the mandible along the skull. Ferdinand Graf Spee (1855-1937), prosector at the Anatomy Institute of Kiel. J Am Dent Assoc. 1980 May;100(5):670-5. No abstract available.
PubMed 6988491Baldridge DW. Leveling the curve of Spee: its effect on mandibular arch length. JPO J Pract Orthod. 1969 Jan;3(1):26-41. No abstract available.
PubMed 5250875
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Injection Platelet-rich Fibrin(I-PRF) in Accelerate Alignment and Leveling in an Adult Sample
- ClinicalTrials.gov ID
- NCT04885842
- Acronym / sponsor ID
- TishreenU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 13 May 2021 (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 this study is to evaluate the effectiveness of injection I-PRF to accelerate alignment and leveling of the upper anterior teeth and reduce the time required for treatment.
Detailed description
What remains the most important and common question for adult patients who want to undergo orthodontic treatment is how long the treatment will take, as the period of orthodontic treatment may take between 18 and 24 months in some cases of malocclusion ,and this may cause discomfort for the patient and reduce cooperation during treatment in addition to the aesthetic problems associated with presence of bracket.
the possibility of an increase of Enamel mineral dissolution and spread of dental caries ,gingival problems and this is due to the increase of the duration of orthodontic treatment.
Orthodontic treatment begins with the leveling and alignment stage and constitutes an important part of the treatment stages, during which the teeth(incisal edges, cusps posterior teeth) are placed on one level and to achieve perfect points of contact between the teeth In some cases of malocclusion especially severe ones, this stage may take about 8 months therefore , the interest of orthodontics has increased in finding new methods and techniques in order to accelerate treatment, Various methods and techniques have been used to accelerate orthodontic treatment Which includes :biomaterial injection, surgical and physical methods. Yet, despite the effectiveness of some of these methods in accelerating dental movement ,each of its disadvantages and side effects on the patient therefore, attention must be paid to anther effective safe and simple non-traumatic method hence the idea of using platelet rich fibrin came.
Platelet rich fibrin is a therapeutic approach and it is a new generation of platelet concentrates Which was introduced to the field of dentistry by choukroun in 2001 who developed this treatment technique.
Platelet rich fibrin injection technology (I-PRF), which is obtained in liquid form for injection has been developed through the concept of reduced speed centrifugation .
PRF is a biomaterial .Autologus is taken from a person's own blood.Unlike PRP, no external bioactive are added to active platelet. Rather, the blood sample remains normal. The importance and therapeutic benefits of platelet-rich fibrin come through the presence of key and other common elements that collectively contribute to the healing processes and regeneration of the soft and bone tissues represented by the presence of fibrin in the form of a matrix with large and significant numbers of leukocytes, cytokines, platelets, in addition to the participation of growth factors which play an important role in the processes of healing.
Platelet rich fibrin is a simple, easy to apply and economical technique that does not require adding any substances to the blood sample as an anticoagulant.
To date, there are no studies on the role that platelet rich fibrin injection can play in accelerating aligning and leveling the upper anterior teeth and reducing the time required for treatments Therefore the aim of study is to verify the effectiveness of injection I-PRF to accelerate alignment and leveling of the upper anterior teeth and reduce the time required for treatment
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled clinical study ,two parallel groups design. The research sample consisted of 18 patients (11 famales,7 males)Patients were randomly assigned to 2 groups using the sample randomization principle. Each group included 8 patient (9 control group applying brackets only)(9 group injection I-PRF with brackets).
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: injection I-PRFinjection I-PRF with brackets |
| Control Group | No intervention | –applying brackets only |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The Clinical Diagnosis the age of patients ranges between 16-24 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to Little irregularity index 20,class1 according angel classification,
Key exclusion criteria (1 listed)
- the presence of any systemic disease that affects the orthodontic movement Diabetes , a patient undergoing previous orthodontic treatment, a patient who takes medicines Cortisone,NSAIDs the affect dental movement . and the presence of bleeding disorders Disturbance in the number of platelets.
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 |
|---|---|---|
| injection I-PRFAlso: control Groupinjection I-PRF with brackets | Other | Study Group |
Primary outcome
alignment and leveling Improvement Percentage(ALIP):
Time frame: 6 Month
Determining the percentage of improvement in alignment and leveling by calculating the value of the change in the Little index in one of the studied time periods (T1) or (T2) or (T3) which is calculated by subtracting the value of the Little index at the studied period of time from the value of the Little index at (T0) When the primary wire is inserted, the value of the little index at (T0) is multiplied by 100 Through the following
1 secondary outcome
Overall Alignment and Leveling Time
Time frame: 6 Month
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 17 May 2021.
- Results publication: PubMed 6988491The gliding path of the mandible along the skull. Ferdinand Graf Spee (1855-1937), prosector at the Anatomy Institute of Kiel. J Am Dent Assoc. 1980 May;100(5):670-5. No abstract available.
- Results publication: PubMed 5250875Baldridge DW. Leveling the curve of Spee: its effect on mandibular arch length. JPO J Pract Orthod. 1969 Jan;3(1):26-41. No abstract available.
- Introducing Choukroun's platelet rich fibrin (PRF) to the reconstructive surgery milieu. J Implant Adv Clin Dent 2009;1:21-30Link provided by the sponsor.
- Une opportunité en paro-implantologie: Le PRF. Implantodontie 2001Link provided by the sponsor.
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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.
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 study testing injection I-PRF in people with Orthodontic Pathological Resorption of External Root, run by Latakia University at 1 site in Syria.
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 1 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 17 May 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 Syria. 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?
alignment and leveling Improvement Percentage(ALIP): (time frame: 6 Month). 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 NCT04885842, 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 17 May 2021.