Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic MovementPhase 1NCT05966987

Assessment of Different Orthodontic Tooth Movements Assisted With Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

A Phase 1 study testing Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin in people with Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic Movement, run by Al-Azhar University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 15 to 22 yearsHealthy volunteers can take part
Conditions the study is for: Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic Movement
What is being tested?: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteEgypt
Study dates: Aug 2023to Sep 2024
Phase: Phase 1
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 22 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

A- leveling and alignment Eligibility criteria
Complete permanent dentition (third molars not included).
Moderate mandibular anterior crowding (with Little's irregularity index score greater than 4 mm) who required nonextraction approach in the mandibular arch.
No tooth size, shape or root abnormalities visible on patient's radiographic records.
No spaces in the mandibular arch.
No blocked out tooth that did not allow for placement of the bracket at the initial bonding appointment.

Show all 24Show fewer

No required management with interproximal stripping, intermaxillary elastics, open NiTi springs, and removable or extra-oral devices. Maxillary molar distalization Inclusion criteria:
1. Age ranges from 14 to 17 years. 2. Bilateral Class II molar relationship. 3. Skeletal Class I or mild Class II relationship. 4. Normal or decreased vertical height. 5. No posterior crowding or spaces. 6. Fully erupted maxillary first and second molars. 7. Congenitally missing or extracted third molars. 8. Good oral hygiene. 9. Absence of any periodontal disease and alveolar bone loss. 10. Absence of medications that may inhibit orthodontic movement
Lower incisor leveling and alignment Inclusion criteria
Complete permanent dentition (third molars not included);
Moderate mandibular anterior crowding (with little's irregularity index score greater than 4 mm) who required non-extraction approach in the mandibular arch;
No tooth size, shape or root abnormalities visible on the patient's radiographic records;
No spaces in the mandibular arch;
No blocked out tooth that did not allow for placement of the bracket at the
initial bonding appointment; 6. No required management with interproximal stripping, inter-maxillary elastics, open NiTi springs, and removable or extra-oral devices. Canine retraction Eligibility criteria
Age, 15 to 25 years;
Class ii division 1 malocclusion with mild or no crowding;
No previous orthodontic treatment;
No systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency;
Adequate oral hygiene;
Probing depth values not exceeding 3 mm across the
Entire dentition;
Adequate thickness of the attached gingiva (1-2 mm);
No radiographic evidence of bone loss

Who cannot join

Patients who required surgery to correct skeletal discrepancies.
Patients with congenital dentoskeletal disorders.
Missed or mutilated teeth in maxillary arch.
Patients with poor oral hygiene and/or periodontally compromised patients Severe dental crowding that necessitates an extraction approach 2. Abnormal anteroposterior and vertical relationships; 3. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that could interfere with otm. -

Trial locations and contacts

1 site in 1 country.

Egypt1 site

AlAzhar university
Cairo

Other trials in Egypt

About this study

Official title: Assessment of Different Orthodontic Tooth Movements Assisted With Low-level Laser Therapy vs. Injectable Plasma-rich Fibrin: A Comparative Clinical Investigation

Read the detailed description

The present prospective clinical study will be undertaken for assessment of the effect of application of Inject able plasma-rich fibrin versus Low-Level Laser Therapy on the rate of different orthodontic tooth movements, namely: canine retraction, mandibular incisors leveling and alignment, maxillary molar distalization and maxillary incisor intrusion.

Conditions: Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic Movement
Being tested: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low-level Laser Therapy vs. Injectable Platelets-rich FibrinCombination product
laser and platelet rich fibrin

Study groups in NCT05966987
Study group	Role	What they receive
i-PRF side: canine retraction	Experimental	application of i-PRF with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol Receives: Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
i-prf side control side	No intervention	i-PRF side:canine retraction control side
LLLT side canine retraction	Experimental	translation of maxillary canine that will be performed with LLLT application according to a standardized protocol Receives: Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
LLLT side canine retraction control side	No intervention	LLLT side canine retraction control side wihout intervention
I-PRF groupMolar distalization group inrervention side	Experimental	Idistalization assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol Receives: Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
I-PRF groupMolar distalization group control side	No intervention	distalization without i-PRF intervention
LLLT group: distalization intervntion side	Experimental	distalization will be commenced with application of LLLT according to a standardized protocol Receives: Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
LLLT group: distalization control side	No intervention	distalization will be commenced without application of LLLT according to a standardized protocol
i-PRF group: leveling and alignment	Experimental	leveling and alignment assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol Receives: Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
LLLT group: leveling and alignment	Experimental	leveling and alignment be commenced with application of LLLT according to a standardized protocol Receives: Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
leveling and alignment without intervention	No intervention	leveling and alignment without intervention
I-PRF group: Intrusion	Experimental	intrusion assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol Receives: Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
LLLT group: Intrusion	Experimental	intrusion assisted with application of LLLT according to a standardized protocol Receives: Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
intrusion control group	No intervention	intrusion without intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

assessment of the effect of application of Injectable plasma-rich fibrin versus Low-Level Laser Therapy on the accelration rate of different orthodontic tooth movements by millimeter
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2023Sep 2024

First posted1 Aug 2023
Study startAug 2023 (estimated)
Primary completionFeb 2024 (estimated)
Study completionSep 2024 (estimated)

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 Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic MovementStudies 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Model description: Factorial Assignment
Masking: None (open label)
Enrolment: 82 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05966987
Sponsor's protocol ID: 923/91
Status last verified: Jul 2023
First submitted: 20 Jul 2023
Last updated: 1 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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
Youssef M, Ashkar S, Hamade E, Gutknecht N, Lampert F, Mir M. The effect of low-level laser therapy during orthodontic movement: a preliminary study. Lasers Med Sci. 2008 Jan;23(1):27-33. doi: 10.1007/s10103-007-0449-7. Epub 2007 Mar 15.
PubMed 17361391

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Different Orthodontic Tooth Movements Assisted With Low-level Laser Therapy vs. Injectable Plasma-rich Fibrin: A Comparative Clinical Investigation
ClinicalTrials.gov ID: NCT05966987
Acronym / sponsor ID: 923/91
Conditions: Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic Movement
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 82 participants (estimated)
Lead sponsor: Al-Azhar UniversityUniversity, hospital or other
Study start: Aug 2023 (estimated)
Primary completion: Feb 2024 (estimated)
Study completion: Sep 2024 (estimated)
First posted: 1 Aug 2023 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 14
Model description: Factorial Assignment

Arm	Type	Receives
i-PRF side: canine retraction	Experimental	Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrinapplication of i-PRF with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol
i-prf side control side	No intervention	–i-PRF side:canine retraction control side
LLLT side canine retraction	Experimental	Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrintranslation of maxillary canine that will be performed with LLLT application according to a standardized protocol
LLLT side canine retraction control side	No intervention	–LLLT side canine retraction control side wihout intervention
I-PRF groupMolar distalization group inrervention side	Experimental	Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich FibrinIdistalization assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol
I-PRF groupMolar distalization group control side	No intervention	–distalization without i-PRF intervention
LLLT group: distalization intervntion side	Experimental	Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrindistalization will be commenced with application of LLLT according to a standardized protocol
LLLT group: distalization control side	No intervention	–distalization will be commenced without application of LLLT according to a standardized protocol
i-PRF group: leveling and alignment	Experimental	Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrinleveling and alignment assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol
LLLT group: leveling and alignment	Experimental	Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrinleveling and alignment be commenced with application of LLLT according to a standardized protocol
leveling and alignment without intervention	No intervention	–leveling and alignment without intervention
I-PRF group: Intrusion	Experimental	Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrinintrusion assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol
LLLT group: Intrusion	Experimental	Combination Product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrinintrusion assisted with application of LLLT according to a standardized protocol
intrusion control group	No intervention	–intrusion without intervention

Who may qualify

Ages: 15 to 22 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (24 listed)

A- leveling and alignment Eligibility criteria
Complete permanent dentition (third molars not included).
Moderate mandibular anterior crowding (with Little's irregularity index score greater than 4 mm) who required nonextraction approach in the mandibular arch.
No tooth size, shape or root abnormalities visible on patient's radiographic records.
No spaces in the mandibular arch.

Key exclusion criteria (4 listed)

Patients who required surgery to correct skeletal discrepancies.
Patients with congenital dentoskeletal disorders.
Missed or mutilated teeth in maxillary arch.
Patients with poor oral hygiene and/or periodontally compromised patients Severe dental crowding that necessitates an extraction approach 2. Abnormal anteroposterior and vertical relationships; 3. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that could interfere with otm. -

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
Low-level Laser Therapy vs. Injectable Platelets-rich Fibrinlaser and platelet rich fibrin	Combination product	I-PRF group: Intrusion, I-PRF groupMolar distalization group inrervention side, LLLT group: Intrusion, LLLT group: distalization intervntion side, LLLT group: leveling and alignment, LLLT side canine retraction, i-PRF group: leveling and alignment, i-PRF side: canine retraction

Primary outcome

assessment of the effect of application of Injectable plasma-rich fibrin versus Low-Level Laser Therapy on the accelration rate of different orthodontic tooth movements by millimeter
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Background: 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.
Results publication: PubMed 17361391Youssef M, Ashkar S, Hamade E, Gutknecht N, Lampert F, Mir M. The effect of low-level laser therapy during orthodontic movement: a preliminary study. Lasers Med Sci. 2008 Jan;23(1):27-33. doi: 10.1007/s10103-007-0449-7. Epub 2007 Mar 15.
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?

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 24 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

assessment of the effect of application of Injectable plasma-rich fibrin versus Low-Level Laser Therapy on the accelration rate of different orthodontic tooth movements by millimeter (time frame: 6 months). 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 NCT05966987, 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 1 Aug 2023.