Clear Aligner AppliancePhase 3NCT07103551
Evaluation of the Efficacy of Injectable Platelet-rich Plasma in Tooth Movement Acceleration With Clear Aligner
A Phase 3 study testing Platelet-rich plasma in people with Clear Aligner Appliance, run by Al-Azhar University.
Trial summary
Aim of the study is evaluation of the efficacy of injectable platelet-rich plasma in orthodontic tooth movement acceleration with clear aligner Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Clear Aligner Appliance
- What is being tested?
- Platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Non-extraction cases
- Complete permanent dentition
- Good oral hygiene
- Healthy periodontal condition
- Single or double arch treatment
- No therapeutic intervention planned intermaxillary or other intraoral or extraoral appliances including lip bumper, elastics and maxillary expansion appliances
- mild to moderate crowding
Who cannot join
- Systemic medical conditions
- Dental anomalies in tooth size or shape
- Current use of anti-inflammatory medications
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy of Injectable Platelet-rich Plasma in Orthodontic Tooth Movement Acceleration With Clear Aligner Therapy
Aim of the study is evaluation of the efficacy of injectable platelet-rich plasma in orthodontic tooth movement acceleration with clear aligner
Read the detailed description
Malocclusion is frequently viewed as detrimental to one' self-worth and overall physical, social, and mental health. On the past few years, more and more grown-up patients have persued orthodontic care and they want attractive and pleasant options instead of traditional braces. CLEAR aligners that meet this need are also subject to technological advancements in the materials used and the methods of production. Consequently, CAT has merged as the leading trend in orthodontic innovation. The primary advateges of clear aligner therapy include the option to remove while eating, enhanced oral hygiene practices, less discomfort for patients,and the capability to visualize the treatment outcome through computer applications.
Clear aligners need to be removed during eating, when drinking hot beverages that may lead to warping, while having sugary beverages, and also when cleaning teeth.
Today, numerous methods have emerged to accelerate orthodontic tooth movement, encompassing invasive,minimally invasive,and non-invasive strategies.
IN addition, the use of medications and autologous biological solutions, like platelet-rich plasma, has been suggested.
One of the recently utilized local agents to accelerate the process of orthodontic tooth movement is platelet-rich plasma.
Platelet-rich plasma is characterized as an autologous concentration of platelets within a small quantity of plasma Prepared from blood centrifuging double spin.
The application of PRP has been used in regenerative dentistry and healing acceleration in oral surgery.
PRP serves as an abundant reservoir of cytokines and contains seven essential growth factors:
- Platelet-derived growth factors .
- Transforming growth factors.
- Epidermal growth factors.
- Vascular endothelial growth factor. The diverse range of growth factors present in PRP might facilitate the simultaneous activation of both osteoblasts and osteoclasts, reinforcing the notion that PRP can influence the movement of teeth during orthodontic treatment.
Also elevated levels of cytokine production during the process of bone remodelling could accelerate tooth movement.
- Conditions
- Clear Aligner Appliance
- Being tested
- Platelet-rich plasma
- Keywords
- Malocclusion, Clear aligner, Platelet-rich plasma
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaBiological
Platelet-rich plasma used during clear aligner therapy for acceleration of Orthodontic Tooth Movement
| Study group | Role | What they receive |
|---|---|---|
| Clear aligner therapy only without injection of platelet-rich plasma | No intervention | Clear aligner only without acceleration |
| Clear aligner Therapy with injection of platelet-rich plasma | Experimental | Clear aligner therapy with injection of platelet-rich plasma Receives: Biological: Platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the amount of tooth movement in group of clear aligner therapy and group of clear aligners with injectable platelet-rich plasma by little's irregularity index
Little's irregularity index is used to measure the amount of tooth movement by measuring the distance between each contact points in anterior teeth before injection and after injection
Measured: Baseline, 3 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Aligner ApplianceStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mahmoud Ali Elhewaity, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103551
- Sponsor's protocol ID
- Clear Aligner and prp
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Injectable Platelet-rich Plasma in Orthodontic Tooth Movement Acceleration With Clear Aligner Therapy
- ClinicalTrials.gov ID
- NCT07103551
- Acronym / sponsor ID
- Clear Aligner and prp
- Conditions
- Clear Aligner Appliance
- Keywords
- Malocclusion, Clear aligner, Platelet-rich plasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 5 Aug 2025 (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.
Aim of the study is evaluation of the efficacy of injectable platelet-rich plasma in orthodontic tooth movement acceleration with clear aligner
Detailed description
Malocclusion is frequently viewed as detrimental to one' self-worth and overall physical, social, and mental health. On the past few years, more and more grown-up patients have persued orthodontic care and they want attractive and pleasant options instead of traditional braces. CLEAR aligners that meet this need are also subject to technological advancements in the materials used and the methods of production. Consequently, CAT has merged as the leading trend in orthodontic innovation. The primary advateges of clear aligner therapy include the option to remove while eating, enhanced oral hygiene practices, less discomfort for patients,and the capability to visualize the treatment outcome through computer applications.
Clear aligners need to be removed during eating, when drinking hot beverages that may lead to warping, while having sugary beverages, and also when cleaning teeth.
Today, numerous methods have emerged to accelerate orthodontic tooth movement, encompassing invasive,minimally invasive,and non-invasive strategies.
IN addition, the use of medications and autologous biological solutions, like platelet-rich plasma, has been suggested.
One of the recently utilized local agents to accelerate the process of orthodontic tooth movement is platelet-rich plasma.
Platelet-rich plasma is characterized as an autologous concentration of platelets within a small quantity of plasma Prepared from blood centrifuging double spin.
The application of PRP has been used in regenerative dentistry and healing acceleration in oral surgery.
PRP serves as an abundant reservoir of cytokines and contains seven essential growth factors:
- Platelet-derived growth factors .
- Transforming growth factors.
- Epidermal growth factors.
- Vascular endothelial growth factor. The diverse range of growth factors present in PRP might facilitate the simultaneous activation of both osteoblasts and osteoclasts, reinforcing the notion that PRP can influence the movement of teeth during orthodontic treatment.
Also elevated levels of cytokine production during the process of bone remodelling could accelerate tooth movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear aligner therapy only without injection of platelet-rich plasma | No intervention | –Clear aligner only without acceleration |
| Clear aligner Therapy with injection of platelet-rich plasma | Experimental | Biological: Platelet-rich plasmaClear aligner therapy with injection of platelet-rich plasma |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Non-extraction cases
- Complete permanent dentition
- Good oral hygiene
- Healthy periodontal condition
- Single or double arch treatment
Key exclusion criteria (3 listed)
- Systemic medical conditions
- Dental anomalies in tooth size or shape
- Current use of anti-inflammatory medications
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 |
|---|---|---|
| Platelet-rich plasmaPlatelet-rich plasma used during clear aligner therapy for acceleration of Orthodontic Tooth Movement | Biological | Clear aligner Therapy with injection of platelet-rich plasma |
Primary outcome
Measuring the amount of tooth movement in group of clear aligner therapy and group of clear aligners with injectable platelet-rich plasma by little's irregularity index
Time frame: Baseline, 3 weeks, and 6 weeks
Little's irregularity index is used to measure the amount of tooth movement by measuring the distance between each contact points in anterior teeth before injection and after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Related trials for Clear Aligner Appliance
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Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment
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Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical Trial
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet-rich plasma in people with Clear Aligner Appliance, run by Al-Azhar University.
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 7 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: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Mahmoud Elhewaity (+201558222026, alimahmoud9779@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the amount of tooth movement in group of clear aligner therapy and group of clear aligners with injectable platelet-rich plasma by little's irregularity index (time frame: Baseline, 3 weeks, and 6 weeks). 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 7 Aug 2025.