Poster Abstracts

Single-Center Retrospective Study of Flowable Umbilical Cord Tissue Allograft Application in Temporomandibular Joint Disorder: An Investigative Case Series

POSTER ABSTRACT

Author(s)

RR

Ryan Robinson, DDS

Owner and Chief Clinical Director
Pain and Sleep Therapy Center
Newark, Delaware
RR

Rachel Reynolds, MSN, FNP-C

FNP and Certified Nutritionist
Pain and Sleep Therapy Center
Newark, Delaware
NL

Naomi Lambert, BS

Clinical Site Coordinator
Regenative Labs
Pensacola, Florida

Abstract Title: Single-Center Retrospective Study of Flowable Umbilical Cord Tissue Allograft Application in Temporomandibular Joint Disorder: An Investigative Case Series

Background: Temporomandibular Disorder (TMD) is a heterogeneous group of orofacial musculoskeletal and neuromuscular conditions involving the temporomandibular joint (TMJ) and surrounding masticatory muscles representing the most common chronic orofacial pain condition [1]. Nearly 10 million patients suffer from TMD in the United States each year with joint arthralgia, displacement, degenerative arthritis, limited and painful mouth opening, painful subluxation of the joint, joint clicking, and referred pain to the periauricular area or head and neck muscles [1,2]. This manifests in the workplace as TMD contributes to almost 18M lost work days per year for every 100,000 working adults [1]. Although there are many treatments for TMD, therapy specific to degenerative pathology of the TMJ disc itself is limited in scope and therapeutic effect. Standard treatment includes simply resting the jaw muscles and avoiding use, massage, physical therapy, medication management, and, when all else fails, surgery.

Purpose/Objectives: This study aims to report observations of a safe and effective alternative intervention method for refractory TMD. The treatment observed centers on a Wharton’s jelly tissue allograft. Wharton’s jelly is a unique structural matrix found in the umbilical cord that serves as a supportive and protective scaffold for arterial and venous blood flow. It primarily comprises collagen I and III, hyaluronic acid, growth factors, proteoglycans, scaffolding proteins, and other cytokines. Quantitative and qualitative properties of Wharton’s jelly have been tested and deemed a highly promising substitute for structural tissue matrixes [3,4]. We hypothesized that if damaged articular cartilage within the temporomandibular joint is supplemented with the analogous structural ECM tissue found in Wharton’s jelly, further deterioration and malfunction of the joint may be mitigated.

Method: Each of the five patients had radiographic evidence of cartilage degeneration of the symptomatic temporomandibular joint and had failed prior systemic treatments that may have included physical therapy, pain medications, and oral appliance use. Each patient received a single Wharton’s jelly tissue allograft application (SecreTextTM from Regenative Labs), a pterygoid release, and mandibular range of motion exercises. Under sterile technique and with musculoskeletal ultrasound guidance, 1cc of Wharton’s jelly flowable allograft (25mg of Wharton’s Jelly tissue) was applied into the TMJ in close approximation to the temporomandibular disc after negative aspiration for blood. All patients were monitored for 30 minutes post-procedure with no reported complications and were discharged in stable condition. Progress was tracked from the application date to 30, 60, and 90 days post-application with CT scans, range of motion assessments, and a patient-recorded questionnaire consisting of an NPRS for chief complaints.

Results: Upon initial assessment, the patients had more than five chief complaints that caused significant discomfort and did not show improvement after receiving standard care. After 90 days of intervention, the patient's self-reported outcomes averaged a 75% improvement in all areas. Their range of motion measurements became normal. Two patients received follow-up CT scans at two years, showing minor improvements in the affected joint. Two received follow-up imaging at 90 days with minimal evidence of change. While the scans are inconclusive, the patient-reported pain levels suggest that the intervention may have positively impacted the patient's health status.

Conclusions: Significant decreases in jaw pain, pain associated with chewing, joint locking, headaches, dizziness, and improved sleep in five patients were observed. All patients tolerated the WJ allograft application without side effects or complications. The CT scans were inconclusive, but the most notable changes were in patients one after 90 days and two after two years. The left condyle on patient one demonstrated a continuous and thin corticated border without evidence of active focal erosions from the previous scan, and subcortical sclerosis, which was apparent in historical imaging, has subsided. Patient two had no improvement in degenerative changes and acute vertical aspect volume loss but a marked increase in proliferative bone formation affecting the posterior surface of the condyle. While the sample size was too small to determine physical differences with imaging, the patient-reported improvements were significant to warrant further studies. The extension of this research will consist of a prospective single-site cohort study with a minimum of 60 patients over an extended period with standardized TMD-related pain scales, CBCT, and MRI scans to define further and evaluate the safety and efficacy of WJ allografts applied to structural tissue defects in the articular cartilage bed of TMD.

References: 1. Maixner W, Diatchenko L, Dubner R, Fillingim RB, Greenspan JD, Knott C, Ohrbach R, Weir B, Slade GD. Orofacial pain prospective evaluation and risk assessment study--the OPPERA study. J Pain. 2011 Nov;12(11 Suppl):T4-11.e1-2. doi: 10.1016/j.jpain.2011.08.002. PMID: 22074751; PMCID: PMC3233836.

2. Valesan LF, Da-Cas CD, Réus JC, Denardin ACS, Garanhani RR, Bonotto D, Januzzi E, de Souza BDM. Prevalence of temporomandibular joint disorders: a systematic review and meta-analysis. Clin Oral Investig. 2021 Feb;25(2):441-453. doi: 10.1007/s00784-020-03710-w. Epub 2021 Jan 6. PMID: 33409693.

3. Davis, J. M., Sheinkop, M. B., & Barrett, T. C. (2022). Evaluation of the Efficacy of Cryopreserved Human Umbilical Cord Tissue Allografts to Augment Functional and Pain Outcome Measures in Patients with Knee Osteoarthritis: An Observational Data Collection Study. Physiologia, 2(3), 109-120. https://doi.org/10.3390/physiologia2030010

4. Converse, G. L., Li, D., Buse, E. E., Hopkins, R. A., & Aljitawi, O. S. (2017). Wharton’s Jelly Matrix Decellularization for Tissue Engineering Applications. In Decellularized Scaffolds and Organogenesis (pp. 25-33). Humana Press, New York, NY. https://doi.org/10.1007/7651_2017_61