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Clinical Trials/NCT05966987
NCT05966987Enrolling By InvitationPhase 1

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

Al-Azhar University1 site in 1 country82 target enrollmentStarted: August 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Enrolling By Invitation
Enrollment
82
Locations
1
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
15 Years to 22 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.
  • No required management with interproximal stripping, intermaxillary elastics, open NiTi springs, and removable or extra-oral devices. Maxillary molar distalization Inclusion criteria:
  • Age ranges from 14 to 17 years.
  • Bilateral Class II molar relationship.
  • Skeletal Class I or mild Class II relationship.
  • Normal or decreased vertical height.
  • No posterior crowding or spaces.
  • Fully erupted maxillary first and second molars.
  • Congenitally missing or extracted third molars.
  • Good oral hygiene.
  • Absence of any periodontal disease and alveolar bone loss.
  • 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;
  • 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

Exclusion Criteria

  • Exclusion criteria:
  • 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
  • Abnormal anteroposterior and vertical relationships;
  • Patients with cleft lip and palate, anomalies, and syndromes;
  • Previous orthodontic
  • Regular medications intake that could interfere with otm. -

Arms & Interventions

LLLT side canine retraction control side

No Intervention

LLLT side canine retraction control side wihout intervention

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

Intervention: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin (Combination Product)

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

Intervention: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin (Combination Product)

I-PRF groupMolar distalization group inrervention side

Experimental

Idistalization assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol

Intervention: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin (Combination Product)

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

Intervention: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin (Combination Product)

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

Intervention: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin (Combination Product)

LLLT group: leveling and alignment

Experimental

leveling and alignment be commenced with application of LLLT according to a standardized protocol

Intervention: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin (Combination Product)

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

Intervention: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin (Combination Product)

LLLT group: Intrusion

Experimental

intrusion assisted with application of LLLT according to a standardized protocol

Intervention: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin (Combination Product)

intrusion control group

No Intervention

intrusion without intervention

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

farouk ahmed hussein

Principal Investigator

Al-Azhar University

Study Sites (1)

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