injection of platelet rich plasma
Otherinjection is done percutaneous using a special needle following the guides of surgical anatomy of the neck to reach the area of vocal folds under the effect of local anesthesia and by using nasofiberoscoby
NCT Number: NCT07350642
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
Trial opening soon.
Get Notified10 year and older
All sexes
Interventional
Not applicable
Assiut university, Asyut, Egypt
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]
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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).
injection is done percutaneous using a special needle following the guides of surgical anatomy of the neck to reach the area of vocal folds under the effect of local anesthesia and by using nasofiberoscoby
It is a type of flexible endoscopies introduced from the patient nose to examine the entire airway reaching the larynx
Time frame: 4 years
Arabic version of VHI is a type of questionnaire the smaller score is the better result with a minimum value equal 0 and the maximum one equal 120,viedo stereoscopic examination is done by flexible nasofiberoscopy ,Acoustic analysis is a computerized system to measure different voice parameters ex fundamental frequency ,jitter and shimmer.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Efficacy of Platelet Rich Plasma Injection for Vocal Fold Sulcus, Scar and Atrophy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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