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

NCT ID: NCT05966987

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-09-30

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.

Conditions

Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic Movement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

Intervention Type: COMBINATION_PRODUCT

laser and platelet rich fibrin

i-prf side control side

i-PRF side:canine retraction control side

Group Type: NO_INTERVENTION

No interventions assigned to this group

LLLT side canine retraction

translation of maxillary canine that will be performed with LLLT application according to a standardized protocol

Group Type: EXPERIMENTAL

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

Intervention Type: COMBINATION_PRODUCT

laser and platelet rich fibrin

LLLT side canine retraction control side

LLLT side canine retraction control side wihout intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

I-PRF groupMolar distalization group inrervention side

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

Group Type: EXPERIMENTAL

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

Intervention Type: COMBINATION_PRODUCT

laser and platelet rich fibrin

I-PRF groupMolar distalization group control side

distalization without i-PRF intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

LLLT group: distalization intervntion side

distalization will be commenced with application of LLLT according to a standardized protocol

Group Type: EXPERIMENTAL

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

Intervention Type: COMBINATION_PRODUCT

laser and platelet rich fibrin

LLLT group: distalization control side

distalization will be commenced without application of LLLT according to a standardized protocol

Group Type: NO_INTERVENTION

No interventions assigned to this group

i-PRF group: leveling and alignment

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

Group Type: EXPERIMENTAL

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

Intervention Type: COMBINATION_PRODUCT

laser and platelet rich fibrin

LLLT group: leveling and alignment

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

Group Type: EXPERIMENTAL

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

Intervention Type: COMBINATION_PRODUCT

laser and platelet rich fibrin

leveling and alignment without intervention

leveling and alignment without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

I-PRF group: Intrusion

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

Group Type: EXPERIMENTAL

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

Intervention Type: COMBINATION_PRODUCT

laser and platelet rich fibrin

LLLT group: Intrusion

intrusion assisted with application of LLLT according to a standardized protocol

Group Type: EXPERIMENTAL

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

Intervention Type: COMBINATION_PRODUCT

laser and platelet rich fibrin

intrusion control group

intrusion without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin

laser and platelet rich fibrin

Intervention Type: COMBINATION_PRODUCT

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.

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

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

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. -

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

farouk ahmed hussein

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AlAzhar university

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 33653326 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17361391 (View on PubMed)

Other Identifiers

923/91

Identifier Type: -

Identifier Source: org_study_id