Root Resorption and Alveolar Bone in the Maxillary Canine Retraction Using Injectable Platelet-rich Fibrin: A Split-Mouth Trial

NCT06634888 | Completed DMC

• 1 other identifier: PhamThiMinhChauCtump
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Prolonged orthodontic treatment is a risk factor for root resorption, so accelerating the speed of tooth movement using different methods can limit tooth root resorption. There are multiple factors causing root resorption, such as orthodontic force level, treatment duration, and methods of quantification of root resorption. PRF, a completely autologous fibrin matrix, was developed as a second-generation platelet concentrate without adding anticoagulants and additives. The injectable platelet-rich fibrin is the liquid form of the substance obtained through low-speed centrifugation. It has many advantages over the conventional form, such as higher rates of regenerative cells and growth factors. In the present study, Cone Beam Computed Tomography (CBCT) was used as a measurement tool for root resorption. CBCT is a helpful tool for evaluating changes in the root length of teeth and surrounding bone tissue.

Conditions

Angle Class I

Keywords

injectable platelet-rich fibrin; canine retraction; root resorption

Outcome Measures

Primary Outcomes (1)

• Our study aims to investigate the effectiveness of i-PRF in root resorption

  CBCT was used before (T0) and four months (T4) after retraction, with imaging conducted using On Demand 3D software according to the As Low As Reasonably Achievable guidelines.

  Our study aims to investigate the effectiveness of i-PRF in root resorption using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)

Secondary Outcomes (1)

• Our study aims to investigate the effectiveness of i-PRF in alveolar bone density.

  Our study aims to investigate the effectiveness of i-PRF in alveolar bone density using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)

Study Arms (2)

Right sides were randomly allocated to treatments with i-PRF

EXPERIMENTAL

The amount of i-PRF was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control.

Diagnostic Test: Injectable platelet rich fbirin

Left sides were randomly allocated to control sides.

PLACEBO COMPARATOR

The placebo was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control.

Diagnostic Test: Injectable platelet rich fbirin

Interventions

Injectable platelet rich fbirin DIAGNOSTIC_TEST

After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. All patients in this study were submitted for Cone beam computed tomography (CBCT) scanning before and after canine retraction. Cone beam computed tomography (CBCT) was used before and four months after retraction, with imaging conducted using the Orthophos SL 3D X-ray machine (Dentsply Sirona, Charlotte, CA, USA) while adhering to As Low As Reasonably Achievable (ALARA) guidelines to minimize radiation exposure

Right sides were randomly allocated to treatments with i-PRF

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who have completed long-term tooth replacement have cervical vertebral maturity at stages CS5, CS6 according to the classification of Baccetti et al.
• Patients with type I Angle malformation have bilateral maxillary first small canines
• No missing teeth except third molars
• No previous orthodontic treatment
• Absence of systemic diseases and dentofacial anomalies, had good periodontal health, had typical values of blood tests, e.g., bleeding time 1 - 4 minutes, coagulation time 5 - 10 minutes
• Patients agreed to participate in the study.

You may not qualify if:

• Patients suffering from bleeding disorders, diabetes, bone diseases, periodontal disease, and cancer are using drugs such as aspirin, heparin, warfarin, non-steroidal anti-inflammatory drugs, and glucocorticoids... affects the speed of tooth movement and the ability to clot and stop bleeding.
• The patient has trauma and facial deformities
• The patient smokes and is pregnant. The patient had other teeth extracted except the first premolar

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, 900000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 33653326 RESULT

MeSH Terms

Conditions

Malocclusion, Angle Class I; Root Resorption

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Tooth Resorption

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: August 27, 2022
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: October 10, 2024

Record last verified: 2022-07

Locations

VN (1)