A Lip Fixation Device Facilitates Labial Salivary Gland Biopsy for Sjögren's Disease

This study uses a new type of lip fixation device to simplify the biopsy for Sjogren's syndrome, thereby enhancing the safety and efficiency of the surgery. Traditional methods for performing this procedure require assistance. The device used in this protocol securely stabilizes the mucosa, enabling clinicians to perform the procedure independently.

To begin, position the patient's supine on the bed, place a cotton ball in the bucco alveolar sulcus to absorb saliva and bleeding during the procedure. Perform triple disinfection of the intraoral mucosa, alveolar processes, teeth, perioral skin, and nasal region using type-three povidone-iodine solution. Now, don sterile surgical gloves, establish a sterile field by applying the sterile fenestrated surgical drape over the patient's face and expose only the mouth area.

Identify the planned incision site on the lower lip located either to the left or right of the midline within the transitional zone between the vermilion border and the labial vestibule. Administer local infiltration anesthesia into the region, bounded by the mucobuccal fold and the buccal surface of the mandibular first premolar using a one milliliter syringe. Five minutes after the anesthetic injection, evert the lower lip to fully expose the surgical site.

Separate the clamp arms of the fixation device. Orient the major axis of the oval pressure ring perpendicular to the vermilion border. Position the backing plate against the labial skin.

Align the oval pressure ring with the intraoral labial mucosa, ensuring that the lip tissue is centered directly over the planned incision site. Now rotate the screw to apply a uniform compressive force through the oval ring to stabilize the lip during the procedure. Ensure the device is tightened appropriately.

Make a linear incision five to seven millimeters in length through the mucosa oriented parallel to the major axis of the oval pressure ring. Avoiding damage to the underlying glands or deep muscle fibers. Insert the tips of the tissue forceps vertically into the incision.

Gently separate the submucosal connective tissue to tease apart the loose fibrous layers surrounding the glands. While grasping the pedicle. Apply gentle traction to elevate the gland and perform blunt dissection by separating the pedicle from surrounding tissue with the forceps alone.

Avoiding sharp dissection, harvest a minimum of four to six labial salivary glands to ensure sufficient tissue. for histopathological analysis. Loosen the screw knob and carefully remove the fixation device from the lower lip.

Apply direct pressure with gauze to achieve hemostasis, if bleeding, obscures the suture field during wound closure, anatomically approximate the wound edges and close the incision using a single simple interrupted suture. Apply gentle digital pressure with a sterile cotton ball to the closed wound for one to two minutes to ensure final hemostasis. A comparative study of device assisted versus conventional labial salivary gland biopsy was conducted.

Procedure time was significantly shorter with the device-assisted technique compared to the conventional technique. Complication rates, including pain, hematoma, and sensory impairment were not significantly different between the two groups. Indicating that the improved efficiency does not compromise safety.

This protocol consistently yields adequate labial gland tissue helping researchers accurately evaluate the focus score. The critical challenge is positioning the pressure ring perpendicular to the vermilion border to ensure optimal surgical exposure. Future work can optimize the device using 3D printing and facilitate multicenter clinical studies and structured training programs.