Vocal Fold Injection by Platelet Rich Plasma

Assiut University

Status

Not yet enrolling

Conditions

Vocal Fold Sulcus ,Scar and Atrophy

Treatments

Device: Nasofiberoscopy

Other: injection of platelet rich plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT07350642

vocal fold injection

Details and patient eligibility

About

a study to asses safety and efficacy of platelet rich plasma injection in some types of vocal fold problems such as sulcus and atrophy to see the improvement in patient voice and its impact on patient quality of life with a good period of follow up

Full description

Vocal fold sulcus, atrophy and scarring are significant causes of dysphonia that present major therapeutic challenges for laryngologists. The etiology of vocal fold scarring is diverse, including phonotrauma, iatrogenic injury from phonomicrosurgery or intubation, malignancy, and radiation therapy. In addition, age-related changes such as the loss of hyaluronic acid, elastic fibers, and bulk causes atrophy can reduce the viable tissue mass.

Vocal fold atrophy leads to reduced pliability and impaired vibratory capacity of the vocal folds. Atrophy is commonly associated with aging (presbyphonia), but it may also result from denervation, disuse, or systemic conditions that affect muscle mass and extracellular matrix composition.

Sulcus vocalis is a structural vocal fold disorder characterized by the presence of a longitudinal furrow along the free edge of the vocal fold. It represents part of the spectrum of SLP disorders, as it involves abnormal thinning, tethering, or loss of the lamina propria, leading to reduced vibratory function. The condition can be congenital, due to defective vocal fold development, or acquired, often associated with chronic inflammation, phonotrauma, or previous vocal fold lesions.

Scarring, atrophy, and sulcus vocalis represent a spectrum of SLP disorders that share pathological features, including inflammatory changes, collagen dysregulation, and depletion of glycosaminoglycans such as hyaluronic acid. Unlike vocal fold paralysis where medialization techniques may restore glottic contact these conditions respond poorly to standard medialization procedures, as glottic gap is not the sole issue. Similarly, exogenous fillers may produce suboptimal vibratory characteristics due to differences in biomechanical properties between artificial materials and native SLP tissue.

These pathological changes primarily affect the superficial lamina propria (SLP) of the vocal folds, an essential layer that provides the viscoelasticity and tensile strength necessary for normal oscillation and sound production.

Disruption of the delicate collagen-elastin-hyaluronic acid balance within the SLP drastically reduces tissue compliance, leading to glottic insufficiency, irregular mucosal wave propagation, and impaired closure. Even minor architectural damage can significantly impact vocal quality, causing dysphonia, vocal fatigue, altered pitch, and decreased quality of life.

Glottic insufficiency due to bowing occurs when the loss of bulk causes the vocal folds to curve inward, leaving a spindle-shaped gap during phonation. This results in increased aperiodicity, as the thin and floppy folds lack sufficient mass and tension for regular vibration. To compensate, patients often engage extrinsic neck muscles to force the folds together, creating hyperfunction that produces a strained, effortful quality and masks the underlying flaccidity.

Current treatment strategies for SLP scarring include voice therapy as a first-line approach, often delivered by specialized speech-language pathologists. In cases with significant glottic insufficiency, surgical augmentation with autologous fat, fascia grafts, or inert injectable materials may be considered; however, these methods carry the risk of further impairing vibratory function. [ Platelet-rich plasma (PRP) has emerged as a promising, minimally invasive alternative. PRP is an autologous concentration of platelets in plasma, enriched with growth factors such as Platelet-erived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor-beta (TGF-β), Hepatocyte Growth Facto (HGF), and basic Fibroblast Growth Factor (bFGF), which can stimulate angiogenesis, collagen remodeling, and tissue regeneration.

PRP exerts anti-inflammatory effects by suppressing signaling Nuclear Factor kappa-light-chain-enhancer of activated B cells (NF-κB ) signaling It has been safely applied across multiple fields, including orthopedics, dermatology, plastic surgery, and rheumatology, with low cost and no risk of immune rejection.[6]

Enrollment

48 estimated patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1-Age ≥ 10 years 2-Gender: both sexes will be included in the study 3-clinical diagnosis of vocal fold sulcus, scar or atrophy. 4-Diagnosis confirmed by video laryngoscope examination. 5-be able to participate and sign informed consent.

Exclusion criteria

1- Laryngeal cancer. 2. Acute laryngeal infection . 3. Systemic diseases that may impair healing, such as:(Uncontrolled diabetes mellitus-Autoimmune disorders affecting the larynx-Coagulopathy or bleeding disorders).

4. Use of systemic corticosteroids or immunosuppressive drugs within the last 4 weeks.

5. Previous laryngeal surgery within the last 6 months 6. Pregnancy or lactation. 7. Known allergy or hypersensitivity to local anesthetics or any component used in PRP preparation.

8. Inability to complete with follow-up visits or voice assessment protocols