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

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

The present prospective clinical study will be undertaken for assessment of the effect of application of Injectable plasma-rich fibrin versus Low-Level Laser Therapy onthe rate of different orthodontic tooth movements,

Study Overview

• Status: Enrolling by invitation
• Conditions: Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic Movement
• Intervention / Treatment: Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • AlAzhar university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

A- leveling and alignment Eligibility criteria

1. Complete permanent dentition (third molars not included).
2. Moderate mandibular anterior crowding (with Little's irregularity index score greater than 4 mm) who required nonextraction approach in the mandibular arch.
3. No tooth size, shape or root abnormalities visible on patient's radiographic records.
4. No spaces in the mandibular arch.
5. 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, 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

  1. Complete permanent dentition (third molars not included);
  2. Moderate mandibular anterior crowding (with little's irregularity index score greater than 4 mm) who required non-extraction approach in the mandibular arch;
  3. No tooth size, shape or root abnormalities visible on the patient's radiographic records;
  4. No spaces in the mandibular arch;
  5. 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

1. Age, 15 to 25 years;
2. Class ii division 1 malocclusion with mild or no crowding;
3. No previous orthodontic treatment;
4. No systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency;
5. Adequate oral hygiene;
6. Probing depth values not exceeding 3 mm across the
7. Entire dentition;
8. Adequate thickness of the attached gingiva (1-2 mm);
9. No radiographic evidence of bone loss

Exclusion Criteria:Exclusion criteria:

1. Patients who required surgery to correct skeletal discrepancies.
2. Patients with congenital dentoskeletal disorders.
3. Missed or mutilated teeth in maxillary arch.
4. 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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: i-PRF side: canine retraction; application of i-PRF with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol	Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin; laser and platelet rich fibrin
No Intervention: i-prf side control side; i-PRF side:canine retraction control side
Experimental: LLLT side canine retraction; translation of maxillary canine that will be performed with LLLT application according to a standardized protocol	Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin; laser and platelet rich fibrin
No Intervention: LLLT side canine retraction control side; LLLT side canine retraction control side wihout intervention
Experimental: I-PRF groupMolar distalization group inrervention side; Idistalization assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol	Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin; laser and platelet rich fibrin
No Intervention: I-PRF groupMolar distalization group control side; distalization without i-PRF intervention
Experimental: LLLT group: distalization intervntion side; distalization will be commenced with application of LLLT according to a standardized protocol	Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin; laser and platelet rich fibrin
No Intervention: LLLT group: distalization control side; distalization will be commenced without application of LLLT according to a standardized protocol
Experimental: i-PRF group: leveling and alignment; leveling and alignment assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol	Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin; laser and platelet rich fibrin
Experimental: LLLT group: leveling and alignment; leveling and alignment be commenced with application of LLLT according to a standardized protocol	Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin; laser and platelet rich fibrin
No Intervention: leveling and alignment without intervention
Experimental: I-PRF group: Intrusion; intrusion assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol	Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin; laser and platelet rich fibrin
Experimental: LLLT group: Intrusion; intrusion assisted with application of LLLT according to a standardized protocol	Combination product: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin; laser and platelet rich fibrin
No Intervention: intrusion control group; intrusion without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 923/91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No