Clinical Trials Directory

Trials / Completed

CompletedNCT07352241

Repeated Injections of i-PRF for Decreasing Root Resorption After the Orthodontic Treatment.

Effect of the Injectable Platelet-rich Fibrin on the Orthodontically Induced Apical Root Resorption Following Non-extraction-based Orthodontic Treatment in Adults: A Randomized Controlled Clinical Trial.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Damascus University · Academic / Other
Sex
All
Age
17 Years – 25 Years
Healthy volunteers
Not accepted

Summary

Mandibular incisor crowding is a frequent issue that prompts many adults to seek orthodontic treatment. The treatment may enhance patients' quality of life, facilitate dental plaque control, and improve the quality of periodontal tissue. However, this treatment is accompanied by several side effects, including resorption of the apical portion of the teeth. Platelet-rich concentrates, such as injectable platelet-rich fibrin, have been shown to have positive effects on both soft- and hard-tissue healing. They may serve as a beneficial self-derived material to prevent this complication.

Detailed description

In recent years, increasing attention has been directed toward biologically driven approaches to modulate tissue responses during orthodontic treatment and minimize adverse effects, such as root resorption. Platelet-rich fibrin (PRF), a second-generation autologous platelet concentrate, has emerged as a promising biomaterial due to its high concentration of platelets, leukocytes, and a fibrin matrix that allows gradual release of multiple growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). However, in 2014, injectable platelet-rich fibrin (I-PRF), which is similar to PRF, was introduced in France by Choukroun, using non-glass tubes and adjusting the centrifugal force. Just like traditional PRF, i-PRF contains high levels of growth factors, stem cells, leukocytes, and cytokines. These growth factors play a crucial role in angiogenesis, tissue regeneration, modulation of inflammation, and bone remodeling, all of which are central processes in orthodontic tooth movement and periodontal healing.

Conditions

Interventions

TypeNameDescription
PROCEDURE4-time i-PRF injection groupI-PRF will be injected in 4 sessions at 28-day intervals. The injection will administered submucosally in the buccal region of the lower incisors, using 2 ml of i-PRF per session (0.5 ml per incisor). Orthodontic wires will be sequenced until they reach 0.019×0.025-inch stainless steel.
PROCEDURESaline injectionSaline serum will be injected in 4 sessions at 28-day intervals. The injection will be administered submucosally in the buccal region of the lower incisors, using 2 ml of i-PRF per session (0.5 ml per incisor). Orthodontic wires will be sequenced until they reach 0.019×0.025-inch stainless steel.

Timeline

Start date
2024-01-13
Primary completion
2024-09-11
Completion
2025-08-04
First posted
2026-01-20
Last updated
2026-01-20

Locations

1 site across 1 country: Syria

Source: ClinicalTrials.gov record NCT07352241. Inclusion in this directory is not an endorsement.