Clinical trial NCT05966987: Assessment of Different Orthodontic Tooth Movements Assisted With Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
Official title: Assessment of Different Orthodontic Tooth Movements Assisted With Low-level Laser Therapy vs. Injectable Plasma-rich Fibrin: A Comparative Clinical Investigation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic Movement
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 82
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial Assignment
Primary purpose: BASIC_SCIENCE

Brief summary: 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,

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.

Eligibility criteria: 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. -

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar university
Study officials:
References:
citation: 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.
citation: 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.