Angle Class INCT06634888
Root Resorption and Alveolar Bone in the Maxillary Canine Retraction Using Injectable Platelet-rich Fibrin: A Split-Mouth Trial
A study testing Injectable platelet rich fbirin in people with Angle Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Prolonged orthodontic treatment is a risk factor for root resorption, so accelerating the speed of tooth movement using different methods can limit tooth root resorption. There are multiple factors causing root resorption, such as orthodontic force level, treatment duration, and methods of quantification of root… Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Angle Class I
- What is being tested?
- Injectable platelet rich fbirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteVietnam
- Study dates
- 27 Aug 2022to 27 May 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients who have completed long-term tooth replacement have cervical vertebral maturity at stages CS5, CS6 according to the classification of Baccetti et al.
- Patients with type I Angle malformation have bilateral maxillary first small canines
- No missing teeth except third molars
- No previous orthodontic treatment
- Absence of systemic diseases and dentofacial anomalies, had good periodontal health, had typical values of blood tests, e.g., bleeding time 1 - 4 minutes, coagulation time 5 - 10 minutes
- Patients agreed to participate in the study.
Who cannot join
- Patients suffering from bleeding disorders, diabetes, bone diseases, periodontal disease, and cancer are using drugs such as aspirin, heparin, warfarin, non-steroidal anti-inflammatory drugs, and glucocorticoids... affects the speed of tooth movement and the ability to clot and stop bleeding.
- The patient has trauma and facial deformities
- The patient smokes and is pregnant. The patient had other teeth extracted except the first premolar
Trial locations and contacts
1 site in 1 country.
About this study
Prolonged orthodontic treatment is a risk factor for root resorption, so accelerating the speed of tooth movement using different methods can limit tooth root resorption. There are multiple factors causing root resorption, such as orthodontic force level, treatment duration, and methods of quantification of root resorption. PRF, a completely autologous fibrin matrix, was developed as a second-generation platelet concentrate without adding anticoagulants and additives. The injectable platelet-rich fibrin is the liquid form of the substance obtained through low-speed centrifugation. It has many advantages over the conventional form, such as higher rates of regenerative cells and growth factors. In the present study, Cone Beam Computed Tomography (CBCT) was used as a measurement tool for root resorption. CBCT is a helpful tool for evaluating changes in the root length of teeth and surrounding bone tissue.
Read the detailed description
Orthodontic treatment encompasses not only the correction of malocclusion and enhancement of dental arch aesthetics but also the preservation or restoration of optimal function and periodontal tissue health. Orthodontic tooth movement (OTM) is stimulated by remodeling the periodontal ligament (PDL) and alveolar bone. Bone remodeling is a process of both bone resorption on the pressure side and bone formation on the tension site.
Prolonged orthodontic treatment is a risk factor for root resorption, so accelerating the speed of tooth movement using different methods can limit tooth root resorption. Root resorption is an undesirable effect that occurs during orthodontic treatment. It is defined as a reduction of root length or cringe. Because root resorption is a multifactorial issue, it is essential to know and focus on the controlling factors that cause root resorption. Therefore, attempts to accelerate tooth movement and reduce treatment duration are significant to orthodontists and patients. Adequate alveolar bone volume and root length are prerequisite conditions for successful orthodontic tooth movement and post-treatment stability orthodontic tooth movement causes the inflammatory process in the periodontium to occur.
Platelet-based preparations from the patient's blood provide a safe alternative to commercially available bioactive materials. PRF, a completely autologous fibrin matrix, was developed as a second-generation platelet concentrate without adding anticoagulants and additives. The injectable platelet-rich fibrin (i-PRF) is the liquid form of the substance that is obtained through low-speed centrifugation (700rpm in 3 minutes) and has many advantages over the conventional form, such as higher rates of regenerative cells and growth factors such as prostaglandins, interleukins, the tumor necrosis factor-a superfamily, and receptor activator of nuclear factor (RANK)/RANK ligand (RANKL)/osteoprotegerin (OPG) are increased in the PDL during orthodontic tooth movement . The presence of these inflammatory mediators in the PDL during orthodontic tooth movement indicates their role in the occurrence of orthodontically induced tooth root resorption.
Cone beam computed tomography (CBCT) imaging allows for a three-dimensional evaluation of teeth and their adjacent anatomical structures, resulting in a detailed visualization of the tooth and its neighboring structures. Subsequently, the area of the tooth resorption can be detected easily. CBCT imaging allows radiation to be focused on the area of anatomical interest while encompassing all hard and soft tissues in three dimensions, providing more significant information with a potential decrease in cumulative radiation exposure for patients.
Little is known about the effects of the placement of these biomaterials on the root length of the moved tooth and on the surrounding supporting bone tissue during orthodontic movement. This study aimed to evaluate and compare these effects after distalization of maxillary canines in alveolar preserved with i-PRF and control alveolar in adult patients using Cone beam computed tomography (CBCT).
- Conditions
- Angle Class I
- Being tested
- Injectable platelet rich fbirin
- Keywords
- injectable platelet-rich fibrin, canine retraction, root resorption
- Medical subject headings
- Malocclusion, Angle Class I, Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable platelet rich fbirinDiagnostic test
After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. All patients in this study were submitted for Cone beam computed tomography (CBCT) scanning before and after canine retraction. Cone beam computed tomography (CBCT) was used before and four months after retraction, with imaging conducted using the Orthophos SL 3D X-ray machine (Dentsply Sirona, Charlotte, CA, USA) while adhering to As Low As Reasonably Achievable (ALARA) guidelines to minimize radiation exposure
Injectable platelet rich fbirinDiagnostic test
All patients in this study were submitted for Cone beam computed tomography (CBCT) scanning before and after canine retraction. Cone beam computed tomography (CBCT) was used before and four months after retraction, with imaging conducted using the Orthophos SL 3D X-ray machine (Dentsply Sirona, Charlotte, CA, USA) while adhering to As Low As Reasonably Achievable (ALARA) guidelines to minimize radiation exposure
| Study group | Role | What they receive |
|---|---|---|
| Right sides were randomly allocated to treatments with i-PRF | Experimental | The amount of i-PRF was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control. Receives: Diagnostic Test: Injectable platelet rich fbirin |
| Left sides were randomly allocated to control sides. | Placebo comparator | The placebo was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control. Receives: Diagnostic Test: Injectable platelet rich fbirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our study aims to investigate the effectiveness of i-PRF in root resorption
CBCT was used before (T0) and four months (T4) after retraction, with imaging conducted using On Demand 3D software according to the As Low As Reasonably Achievable guidelines.
Measured: Our study aims to investigate the effectiveness of i-PRF in root resorption using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)
Secondary outcomes (1)
Our study aims to investigate the effectiveness of i-PRF in alveolar bone density.
CBCT was used before (T0) and four months (T4) after retraction, with imaging conducted using On Demand 3D software according to the As Low As Reasonably Achievable guidelines.
Measured: Our study aims to investigate the effectiveness of i-PRF in alveolar bone density using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start27 Aug 2022
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angle Class IStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634888
- Sponsor's protocol ID
- PhamThiMinhChauCtump
- Status last verified
- Jul 2022
- First submitted
- 7 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
PubMed 33653326
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Resorption and Alveolar Bone in the Maxillary Canine Retraction Using Injectable Platelet-rich Fibrin: A Split-Mouth Trial
- ClinicalTrials.gov ID
- NCT06634888
- Acronym / sponsor ID
- PhamThiMinhChauCtump
- Conditions
- Angle Class I
- Keywords
- injectable platelet-rich fibrin, canine retraction, root resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 27 Aug 2022 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 10 Oct 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.
Prolonged orthodontic treatment is a risk factor for root resorption, so accelerating the speed of tooth movement using different methods can limit tooth root resorption. There are multiple factors causing root resorption, such as orthodontic force level, treatment duration, and methods of quantification of root resorption. PRF, a completely autologous fibrin matrix, was developed as a second-generation platelet concentrate without adding anticoagulants and additives. The injectable platelet-rich fibrin is the liquid form of the substance obtained through low-speed centrifugation. It has many advantages over the conventional form, such as higher rates of regenerative cells and growth factors. In the present study, Cone Beam Computed Tomography (CBCT) was used as a measurement tool for root resorption. CBCT is a helpful tool for evaluating changes in the root length of teeth and surrounding bone tissue.
Detailed description
Orthodontic treatment encompasses not only the correction of malocclusion and enhancement of dental arch aesthetics but also the preservation or restoration of optimal function and periodontal tissue health. Orthodontic tooth movement (OTM) is stimulated by remodeling the periodontal ligament (PDL) and alveolar bone. Bone remodeling is a process of both bone resorption on the pressure side and bone formation on the tension site.
Prolonged orthodontic treatment is a risk factor for root resorption, so accelerating the speed of tooth movement using different methods can limit tooth root resorption. Root resorption is an undesirable effect that occurs during orthodontic treatment. It is defined as a reduction of root length or cringe. Because root resorption is a multifactorial issue, it is essential to know and focus on the controlling factors that cause root resorption. Therefore, attempts to accelerate tooth movement and reduce treatment duration are significant to orthodontists and patients. Adequate alveolar bone volume and root length are prerequisite conditions for successful orthodontic tooth movement and post-treatment stability orthodontic tooth movement causes the inflammatory process in the periodontium to occur.
Platelet-based preparations from the patient's blood provide a safe alternative to commercially available bioactive materials. PRF, a completely autologous fibrin matrix, was developed as a second-generation platelet concentrate without adding anticoagulants and additives. The injectable platelet-rich fibrin (i-PRF) is the liquid form of the substance that is obtained through low-speed centrifugation (700rpm in 3 minutes) and has many advantages over the conventional form, such as higher rates of regenerative cells and growth factors such as prostaglandins, interleukins, the tumor necrosis factor-a superfamily, and receptor activator of nuclear factor (RANK)/RANK ligand (RANKL)/osteoprotegerin (OPG) are increased in the PDL during orthodontic tooth movement . The presence of these inflammatory mediators in the PDL during orthodontic tooth movement indicates their role in the occurrence of orthodontically induced tooth root resorption.
Cone beam computed tomography (CBCT) imaging allows for a three-dimensional evaluation of teeth and their adjacent anatomical structures, resulting in a detailed visualization of the tooth and its neighboring structures. Subsequently, the area of the tooth resorption can be detected easily. CBCT imaging allows radiation to be focused on the area of anatomical interest while encompassing all hard and soft tissues in three dimensions, providing more significant information with a potential decrease in cumulative radiation exposure for patients.
Little is known about the effects of the placement of these biomaterials on the root length of the moved tooth and on the surrounding supporting bone tissue during orthodontic movement. This study aimed to evaluate and compare these effects after distalization of maxillary canines in alveolar preserved with i-PRF and control alveolar in adult patients using Cone beam computed tomography (CBCT).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right sides were randomly allocated to treatments with i-PRF | Experimental | Diagnostic Test: Injectable platelet rich fbirinThe amount of i-PRF was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control. |
| Left sides were randomly allocated to control sides. | Placebo comparator | Diagnostic Test: Injectable platelet rich fbirinThe placebo was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients who have completed long-term tooth replacement have cervical vertebral maturity at stages CS5, CS6 according to the classification of Baccetti et al.
- Patients with type I Angle malformation have bilateral maxillary first small canines
- No missing teeth except third molars
- No previous orthodontic treatment
- Absence of systemic diseases and dentofacial anomalies, had good periodontal health, had typical values of blood tests, e.g., bleeding time 1 - 4 minutes, coagulation time 5 - 10 minutes
Key exclusion criteria (3 listed)
- Patients suffering from bleeding disorders, diabetes, bone diseases, periodontal disease, and cancer are using drugs such as aspirin, heparin, warfarin, non-steroidal anti-inflammatory drugs, and glucocorticoids... affects the speed of tooth movement and the ability to clot and stop bleeding.
- The patient has trauma and facial deformities
- The patient smokes and is pregnant. The patient had other teeth extracted except the first premolar
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 platelet rich fbirinAfter the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. All patients in this study were submitted for Cone beam computed tomography (CBCT) scanning before and after canine retraction. Cone beam computed tomography (CBCT) was used before and four months after retraction, with imaging conducted using the Orthophos SL 3D X-ray machine (Dentsply Sirona, Charlotte, CA, USA) while adhering to As Low As Reasonably Achievable (ALARA) guidelines to minimize radiation exposure | Diagnostic test | Right sides were randomly allocated to treatments with i-PRF |
| Injectable platelet rich fbirinAll patients in this study were submitted for Cone beam computed tomography (CBCT) scanning before and after canine retraction. Cone beam computed tomography (CBCT) was used before and four months after retraction, with imaging conducted using the Orthophos SL 3D X-ray machine (Dentsply Sirona, Charlotte, CA, USA) while adhering to As Low As Reasonably Achievable (ALARA) guidelines to minimize radiation exposure | Diagnostic test | Left sides were randomly allocated to control sides. |
Primary outcome
Our study aims to investigate the effectiveness of i-PRF in root resorption
Time frame: Our study aims to investigate the effectiveness of i-PRF in root resorption using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)
CBCT was used before (T0) and four months (T4) after retraction, with imaging conducted using On Demand 3D software according to the As Low As Reasonably Achievable guidelines.
1 secondary outcome
Our study aims to investigate the effectiveness of i-PRF in alveolar bone density.
Time frame: Our study aims to investigate the effectiveness of i-PRF in alveolar bone density using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)
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 10 Oct 2024.
- Results publication: PubMed 33653326Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
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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 Injectable platelet rich fbirin in people with Angle Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 3 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 10 Oct 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 Vietnam. 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. Some participants in this study may receive a placebo. 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?
Our study aims to investigate the effectiveness of i-PRF in root resorption (time frame: Our study aims to investigate the effectiveness of i-PRF in root resorption using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)). 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 NCT06634888, which also lists 1 linked publication.
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 10 Oct 2024.