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

Summary

This protocol outlines the methodology for utilizing a lip fixation device in labial salivary gland biopsy, along with its associated advantages.

Abstract

The protocol aims to standardize and simplify labial salivary gland biopsy (LSGB) in suspected Sjögren's disease (SjD) using a lip fixation device, enabling safe, efficient, and operator-independent procedures with reduced technical difficulty, especially for junior rheumatologists. We developed a step-by-step protocol encompassing preoperative assessment, antisepsis, local anesthesia, device-assisted lip stabilization, precise vertical incision (5-7 mm), blunt dissection, gland harvesting (minimum 4-6 glands), and standardized closure. The device consists of two clamp arms, an oval pressure ring (major axis 2.4 cm, minor axis 1.5 cm), a matching backing plate separated by a 2.1 cm gap, and a precision screw mechanism. After the patient was positioned supine on the bed, clinical inspection was performed, followed by a "go/no-go" assessment to exclude localized active infection, mucosal ulceration, significant debris, or lip masses. Triple antisepsis is performed with alcohol-free Type III povidone-iodine. Local infiltration anesthesia is administered away from the incision site. The lip is everted and stabilized by the device; a vertical incision is made parallel to the pressure ring axis, penetrating the epithelium while avoiding deep glands or muscle. Glands are identified as pale-yellow translucent spherules (1-2 mm) and harvested by blunt dissection. Closure is achieved with a single interrupted suture, and hemostasis is verified. The protocol enables solo performance, reduces procedure time compared with conventional methods (8.72 ± 1.88 min vs. 18.11 ± 2.65 min, p < 0.001), yields comparable complication rates between groups (all p > 0.05), and ensures acquisition of adequate tissue (>8 mm², focus score assessment feasible). The device's elastic compression prevents tissue injury despite secure stabilization, and predefined troubleshooting steps manage bleeding or suboptimal yield. This protocol standardizes LSGB with a fixation device, overcoming manual retraction challenges, reducing reliance on assistants, and supporting training and quality assurance in rheumatology, while maintaining diagnostic accuracy and patient safety.

Introduction

Sjögren's disease (SjD) is a chronic autoimmune disorder characterized by lymphocytic infiltration of exocrine glands, particularly the salivary glands, leading to progressive glandular dysfunction and xerostomia¹. Over the years, multiple classification criteria for SjD have consistently designated focal lymphocytic sialadenitis, identified histologically by labial salivary gland biopsy (LSGB), as a key diagnostic criterion^2,3,4. This histopathological feature demonstrates higher specificity than subjective clinical manifestations such as xerostomia, particularly in patients with suspected SjD when serological markers (e.g., anti-SSA/Ro) or other clinical features are equivocal or absent. In addition to its established role in diagnostic classification, LSGB provides clinically relevant prognostic information, most notably regarding the risk of lymphoma development, applicable to both seronegative and seropositive patients⁵. However, LSGB remains technically challenging, particularly for junior rheumatologists, due to factors such as the inherent slipperiness of the labial mucosa. Conventional manual lip retraction often requires either an additional operator or patient cooperation, which considerably complicates the procedure.

To ensure mechanical stabilization of the everted lip and achieve controlled, localized tissue compression, a dedicated clamping device was utilized. This lip fixation device comprises a pressure ring and a backing plate, both rigidly stabilized by a precision screw mechanism, enabling uniform and precisely adjustable compression while effectively immobilizing the everted lip during labial salivary gland biopsy. Compared with conventional LSGB methods, the proposed device-assisted approach reduces procedure time, provides consistent compression with minimal bleeding, reduces inter-operator variability, and offers a more accessible and reproducible technique-rendering it especially suitable for junior clinicians, solo practitioners, and resource-constrained settings where assistant support is limited or unavailable.

Protocol

This study was approved by the Medical Ethics Committee of Sun Yat-sen Memorial Hospital (approval no. SYSEC-KY-KS-2018-012). All procedures were performed in accordance with the principles of the Declaration of Helsinki.

1. Preparation (Figure 1)

1. Prepare the following materials: Type III Povidone-Iodine Solution (0.45%~0.55% iodine, 0.09%~0.11% chlorhexidine gluconate; alcohol-free), a local anesthetic solution containing 2% (w/v) mepivacaine hydrochloride and epinephrine at a concentration of 1:100,000, a sterile fenestrated surgical drape, as well as sterile cotton balls and gauze.
2. Prepare the following instruments: a scalpel handle and blade, a tissue forceps, small dissecting scissors, a needle holder, suture, and a 1-mL syringe (Figure 1A). The lip fixation device consists of two clamp arms, an oval pressure ring, a compatible oval backing plate, and a screw knob (Figure 2). The oval pressure ring has a major axis of approximately 2.4 cm and a minor axis of approximately 1.5 cm; a 2.1 cm gap separates the ring from the oval backing plate. Constructed from 18Cr stainless steel (containing 18 wt% chromium), the device is fully compatible with high-pressure steam sterilization.

2. Patient positioning

1. Conduct the procedure in a standard medical treatment room. Position the patient supine on the bed. Ensure the patient is comfortable and the head is supported to minimize movement during the procedure.

3. Pre-operative assessment

1. Perform clinical inspection.
   1. Evaluate dentition and intraoral mucosa for signs of active infection (e.g., periodontal abscesses, severe gingivitis), severe oral mucosal erosion or ulceration, significant debris or plaque accumulation adjacent to the planned incision site, or any confirmed or suspected neoplastic or non-neoplastic mass lesions involving the lip region.
2. Perform a Go/No-Go assessment.
   1. Defer the procedures in the presence of: (1) localized active infection; (2) severe oral mucosal erosion or ulceration; (3) significant debris or plaque accumulation adjacent to the planned incision site.
   2. Reschedule the procedure only after these findings are resolved. Postpone the biopsy if a mass lesion involving the lip region is identified, as such lesions require comprehensive evaluation and management by a qualified oral and maxillofacial surgeon or medical oncologist.

4. Surgical field setup and anesthesia

1. Place a cotton ball in the bucco-alveolar sulcus to absorb saliva and bleeding during the procedure.
2. Perform triple disinfection of the intraoral mucosa, alveolar processes, teeth, perioral skin, and nasal region using Type III povidone-iodine solution.
3. Don sterile surgical gloves. Establish a sterile field by applying the sterile, fenestrated surgical drape over the patient's face, exposing only the mouth area.
4. Administer anesthesia.
   1. 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.
   2. Administer local infiltration anesthesia into the region bounded by the mucobuccal fold and the buccal surface of the mandibular first premolar using a 1-mL syringe.
      ​NOTE: Direct injection into the planned incision site must be strictly avoided, as it may induce tissue edema and thereby significantly increase the technical complexity of subsequent dissection. This study did not use a fixed anesthetic volume; instead, the anesthetic was administered slowly, beginning with an initial dose of approximately 0.4 mL and assessing for loss of sensation at the planned incision site before proceeding. This volume was typically sufficient to achieve adequate anesthesia for the biopsy procedure.
   3. Allow 5 min for the anesthetic to take effect before proceeding to the next step.
      ​NOTE: In select cases involving heightened tissue sensitivity, the total volume was increased incrementally, as needed, up to 0.8-1.0 mL.

5. Stabilization

1. Position the device.
   1. 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 (Figure 1B).
   2. Position the backing plate against the labial skin and align the oval pressure ring with the intraoral labial mucosa, ensuring that the lip tissue is centered directly over the planned incision site.
      NOTE: The major axis of the oval pressure ring must not be aligned parallel to the vermilion border, as such orientation may impede surgical access and restrict the incision length to no more than 2 mm (Figure 1C).
2. Secure the device.
   1. The device employs a precision screw-driven clamping mechanism. Rotate the screw to apply a uniform compressive force through the oval ring to stabilize the lip during LSGB. Ensure the device is tightened appropriately.
      ​NOTE: Do not leave the device too loose, as this will result in inadequate stabilization and impede the surgical procedure.

6. Incision and dissection

1. Make a linear incision (5-7 mm in length) through the mucosa, oriented parallel to the major axis of the oval pressure ring (Figure 1D). Control the depth of the incision to penetrate the epithelium but strictly avoid damaging the underlying glands or deep muscle fibers.
2. Insert the tips of the tissue forceps vertically into the incision. Gently separate the submucosal connective tissue using the tips to carefully tease apart the loose fibrous layers surrounding the glands.
3. Upon dissection, identify the gland. The labial salivary glands appear as discrete, pale-yellow, translucent spherules (1-2 mm in diameter) with well-defined margins.
4. Gently grasp the pedicle (the fibrous connection to the mucosa) using fine tissue forceps. Apply gentle traction to elevate the gland, then perform blunt dissection by separating the pedicle from surrounding tissue with the forceps alone. Avoid sharp dissection techniques, such as scissor-based or electrocautery methods, to preserve histopathological integrity.
5. Collect the specimen.
   1. Harvest a minimum of 4 to 6 labial salivary glands to ensure sufficient tissue for histopathological analysis.
   2. Place the excised glands immediately into the designated specimen container (e.g., 10% neutral buffered formalin).
      ​NOTE: In cases of suboptimal glandular yield, blunt dissection may be extended into the lateral submucosal space adjacent to the incision without enlarging the incision, which is maintained at a length of 5-7 mm.

7. Closure and hemostasis

1. Loosen the screw knob and carefully remove the fixation device from the lower lip.
   NOTE: In cases where post-removal bleeding obscures the suture field during wound closure, direct pressure applied with gauze achieves rapid and effective hemostasis.
2. Anatomically approximate the wound edges. Close the incision using a single simple interrupted suture (Figure 1E).
   NOTE: Due to the limited length of the incision (5-7 mm), one suture is typically sufficient to achieve adequate closure.
3. Apply gentle digital pressure with a sterile cotton ball to the closed wound for 1-2 min to ensure final hemostasis.
4. Instruct the patient to maintain oral hygiene and to return to the clinic 7 days post-operatively for suture removal and wound evaluation.

Results

A prospective study was conducted among 470 patients with suspected SjD who underwent LSGB, approved by the Medical Ethics Committee of Sun Yat-sen Memorial Hospital. The cohort comprised 443 women (94%) with a mean age of 45.8 ± 14.5 years, who underwent LSGB utilizing the lip fixation device from October 2020 to June 2025. Among the cohort, 279 patients (59.3%) exhibited a labial focus score (FS) of ≥1, with all biopsy sample areas measuring greater than 8 mm², demonstrating the reliability of the protocol in obtaining...

Discussion

The success of our lip fixation device-assisted LSGB technique depends on several critical procedural steps. First and foremost, precise device positioning is critical. Orient the major axis of the oval pressure ring perpendicular to the vermilion border, and align the vertical incision (5-7 mm in length) parallel to the major axis of the pressure plate to ensure optimal surgical exposure and effective compression-induced hemostasis. Conversely, aligning the incision along the minor axis of the pressure plate compromises...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Blade	Shanghai jinghuan medicial	20212020337
Gauze	Winner medical Co., Ltd	20140001
Lip Fixation Device	Cnstrong	9CM-large	Material Specifications 18Cr" (18% Chromium stainless steel) Disinfection method: High-pressure steam sterilization
Needle holder	Geister Medical Co., Ltd.	20121010135
Scalpel handle	Shanghai Medical Devices (Group) Co., Ltd. Surgical Instrument Factory	20121010945
Scandonest	Septodont	86978859000048	containing 2% (w/v) mepivacaine hydrochloride and epinephrine at a concentration of 1:100,000
Small dissecting scissors	Alcon Laboratories, Inc.	20172041227
Sterile cotton balls	Qingdao Aibaze Medical Co., Ltd.	20150153
Sterile fenestrated surgical drape	Nanchang Tongda Medical Devices Co., Ltd.	20202140426
Suture	Hangzhou huawei medical supples Co.,LTD	20142020178
Syringe (1 mL)	Shandong Weigao Group Medical Polymer Products Co., Ltd.	20163141593
Tissue forceps	Shanghai Medical Devices (Group) Co., Ltd. Surgical Instrument Factory	20051010331
Type III Povidone-Iodine Solution	Winner medical Co., Ltd	20150209	0.45%–0.55% iodine, 0.09%–0.11% chlorhexidine gluconate; alcohol-free