1. Consultant, Smile Plus Dental Care Pvt Ltd, Kathmandu, Nepal.
2. Lecturer, Department of Oral & Maxillofacial Surgery, Sir Salimullah Medical College, Dhaka.
3. Associate Professor, Department of Oral Maxillofacial Surgery, Bangabandhu Sheikh Mujib Medical University, Dhaka.
4. Professor, Department of Oral & Maxillofacial Surgery, Bangabandhu Sheikh Mujib Medical University, Dhaka.

* Correspondence: junhasan83@gmail.com

Keywords: Sclerotherapy, Sodium Tetradecyl sulphate (STS), Benign ,Vascular Lesion

1. INTRODUCTION

A congenital lesion known as a vascular malformation usually affects the head, neck, and oral cavity. Vascular malformations are bluish, compressible, and non-pulsatile [1]. Vascular anomalies do not spontaneously disappear and do not present with clinically distinct symptoms. Depending on the type, location, and depth of the lesion as well as the patient’s health, they could be treated with laser therapy, embolization, electrocauterization, steroid administration, surgical removal, or sclerotherapy [2]. Among the many substances used in sclerotherapy, sodium tetradecyl sulfate is known to cause thrombosis and extravascular inflammation, which leads to the ischemic necrosis of blood vessels [3]. Based on the blood vessel that is associated to the lesion, these malformations can be divided into arterial, arteriovenous, venous, capillary, and lymphatic malformations.  The majority of the time, an intraoral lesion is asymptomatic, but it never goes away on its own and, if left untreated, can cause bleeding, pain, tissue necrosis, secondary infection, or aesthetic abnormalities [4]. Doppler ultrasound is advised for assessment, and computed tomography or MRI are the finest add-ons. Vascular lesions typically manifest as chronic mild intermittent bleeding, which frequently happens in response to minor mouth trauma like brushing or the eruption of new teeth. There may also be changes in the color or temperature of the face, asymmetry, auditory bruit, palpable thrill, discolored mucosa, and persistent or recurrent oral infections [5]. Life-threatening circumstances like bleeding, high output cardiac failure, and ischemia necrosis brought on by the “steal phenomenon” can make them more difficult [6]. The most often utilized treatment for vascular abnormalities is surgical removal. However, the need for less intrusive procedures has led to the development of sclerotherapy, which is particularly helpful in cases involving significant anatomical features or minor lesions [7]. Sclerosants including sodium tetradecyl sulfate, ethanolamine oleate, ethibloc, and bleomycin are utilized to treat the condition [8]. These substances frequently stimulate the vascular endothelial intima, produce extravasation of inflammatory responses, and ultimately result in vascular fibrosis and blockage [9]. If vascular malformations begin to produce clinical signs or unpleasant physical symptoms, therapeutic intervention is necessary [10]. The surgical approach, intralesional steroids, laser, cryotherapy, and sclerotherapy are the most often used treatments for minor lesions [11]. For bigger lesions, radiation therapy, systemic corticosteroids, interferon, and embolization are employed. Surgery is kept as a last resort due to the risks of intraoperative and postoperative hemorrhage as well as postoperative scars [12]. Furthermore, functional and physical constraints frequently preclude a full surgical resection [13]. Intralesional steroids may suppress the adrenal glands and weight gain as well as produce atrophy and necrosis [14]. Laser therapy is an expensive procedure that might cause skin atrophy, temporary hyperpigmentation, mild skin depression, scarring, or permanent hyperpigmentation. Scarring and hyperpigmentation can potentially be side effects of cryotherapy [15]. Sclerotherapy is a minimally invasive, safe, effective method for treating benign vascular lesions because there is no risk of bleeding. This non-invasive technique is simple to use, cost-effective, and can be repeated as often as necessary [16,17]. Even if sclerotherapy only partially shrinks the lesion, it offers ideal preparation for subsequent surgery to remove the remaining lesion with less hemorrhage. The best adjuvant to following surgery is sclerosing. Sclerosing agents have been made from a variety of chemicals, including ethanol, STS, and bleomycin [18]. Absolute ethanol is known to be the most effective sclerosant [19]. The primary method for treating deeper lesions, according to [20], is therapy with 100% ethanol. A number of adverse consequences, including tissue necrosis, hypertension, pulmonary embolisms, and hemolysis, have been linked to 100% ethanol, according to previous investigations. However, STS 3% is currently utilized to treat vascular malformations and is connected to reduced problems, adverse effects, and recurrence of lesions [21]. Additionally, based on further research, STS may be recommended for the treatment of lesions for which extensive coverage is required, particularly in pediatric instances where ethanol doses are constrained. Additionally, STS has been shown to be a less neurotoxic chemical with less post-procedure edema. The purpose of the current study was to assess the effectiveness of 3% sodium tetradecyl sulphate (STS) sclerotherapy in the treatment of benign oral and perioral vascular lesions. There are many patients with benign vascular lesions in Bangladesh but so far there is no established method to manage these patients properly. Surgical therapy, systemic and intralesional corticosteroids, intralesional injection of sclerosing agents and interferon, laser, embolization, cryotherapy, and radiation therapy have all been proposed as treatments for benign vascular lesions [22]. Such a wide range of treatment options demonstrates that no single method is completely satisfactory in the treatment of vascular lesions. Sclerotherapy, an alternative to surgery can induce regression of vascular lesions and is now becoming the first choice of treatment for vascular lesions due to its numerous advantages, including less invasiveness and the ability to repeat this procedure as often as necessary. Various sclerosing agents have been used to see their effectiveness in the management of vascular lesions. Each has advantages and disadvantages. Several research findings have shown that absolute ethanol can cause tissue necrosis, hypertension, pulmonary embolisms, and hemolysis. STS 3%, on the other hand, is currently used in the treatment of VMs and has been linked to lesser side effects, fewer repetition of lesions, and reduced complications [23].Based on the efficacy of 3% STS in the treatment of venous malformations in the oral cavity and perioral lesions, this drug will be chosen as the treatment of choice in this study. This study observed the efficacy of Sclerotherapy with 3% sodium tetradecyl sulphate (STS) in the treatment of benign oral and perioral vascular lesions. To assess the effectiveness of sclerotherapy with 3%sodium tetradecyl sulphate on the basis of clinical improvement. To evaluate the regression of the lesion by its size after Sclerotherapy with 3% sodium tetradecyl sulphate (STS).To observe the complications (swelling, pain, ulceration, tissue necrosis, nerve damage, anaphylaxis) after administrating 3% sodium tetradecyl  sulphate (STS).

2. MATERIALS & METHOD

This is a Quasi Experimental study performed at Oral and Maxillofacial Surgery Department, Bangabandhu Sheikh Mujib Medical University (BSMMU) Dhaka, Bangladesh Study population includes Patients with oral and perioral vascular benign lesion. Study samples consist of patient diagnosed with oral and peri oral benign vascular lesions attending outdoor clinic of Oral and Maxillofacial Surgery Department, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. The following equation is used to calculate the sample size:

Here,

n= sample size

u=1.96 (confidence interval 95%)

v=0.84 (table value)

π=75% or 0.75

πo= 50% or 0.5 [24]

so

   = 29

Here calculative sample size is 29. To compensate drop out, inadequate data, laboratory findings and ineligible information, the sample size will be increased to 35. So total sample size will be 35. A method known as “purposive sampling technique” was employed, in which the researcher used their own judgment to select individuals of the population to take part in the study. Each subject who met the inclusion criteria was chosen until the necessary sample size was reached. Instruments and materials used1.3ml disposal plastic syringe,2.26gauge needle or hypodermic needle, 3.3% Sodium 3ml tetradecyl sulphate and Measuring scale or Measuring Tape. By causing the most endothelium damage possible with the least amount of thrombus development, STS causes the lesion to fibrose, which causes it to shrink. Obliteration of the vascular lumen may or may not be permanent. A sclerosing agent is injection of sodium tetradecyl sulfate. An intravenous infusion can result in thrombus development and intima irritation. The injected vein is typically blocked by this. Vein obliteration can be partial or total and may or may not be permanent as a result of the subsequent growth of fibrous tissue. Proper counseling was done. Informed written consent was obtained to include them in the study and for the injection. The lesions were photographed. The intralesional injection of 3% Sodium Tetradecyl Sulphate (STS) was administered. The dose was altered based on the location, size, and patient weight of patients. The medication was injected directly into the lesion after being confirmed by aspiration with a 26G needle. The injection continued until there was a modest elevation of the lesion. On the seventh day, the patients were observed, and it was suggested that they notify if there were any difficulties. For the second and subsequent procedures, patients were instructed to return after a 2-week break. Four weeks following the final session of serotherapy, the impact of sclerotherapy was examined. Up to 6 months of additional follow-up with the patients were conducted to look for any problems or recurrences. At every follow-up appointment, pictures were taken to show how the injections had worked. Different typed of data were collected through interview, clinical examination and laboratory investigation. All participants’ complete medical histories were recorded on the History sheet. A pre-designed data entry sheet was used to record the pertinent information gleaned from the clinical examination and medical history. Data from laboratory reports was also carefully recorded in the data sheet. With the proper tools and techniques, computer-based statistical analysis was performed. Using SPSS 26 for data processing and analysis (Statistical program for Social Sciences). The statistically significant difference between the two groups was examined using the Chi-square test and the Independent Sample T-test. Statistical significance was defined as a P-value 0.05. On a table, graph, and diagram, the compiled information was displayed as number of patients and percentages.

3. RESULTS & DISCUSSION

Figure 01: Age distribution of patients

 Figure 01 illustrates the age distribution of the study patients. Among 35 patients, mean age was 23.17 (±16.13) years. Minimum age was 4, whereas maximum age was 63 years.  Most of the patients, 15 (42.85%) belong to age group between 11 to 20 years and 8 (22.86%) patients belong to age group between 0 to 10 years, 5 (14.28%) patients belong to age group between 21 to 30 years. 2 (5.71%) patients belong to each age group between 31 to 40, 51 to 60 and more than 60 years group. Only 1 (2.86%) patient is from 41 to 50 age group.

Figure 02: Distribution of patients by their gender (N=35)

The distribution of sex among the patients is seen in Figure 2. 26 (74%) of the patients were female, whereas 9 (26%) were male. The ratio of men to women was 1:2.89. Male and female gender distribution did not differ much. (p = 0.775).

Figure 03: Distribution of patients by lesion Site

Most common site of AV malformation ware Tongue and Buccal mucosa. Maximum 11 patients (31.43%) were presented with lesion involving Buccal mucosa and 11patients (31.43%) had lesions on Tongue. Lesion involving Lower lip ware 5 (14.29%), Soft palate was 3 (8.57%) and Upper lip was 5 (14.29%).

Table 01: Onset time of the lesion

Onset time	(Number of Patients-35)	Percentage (%)
At Birth	3	8.57%,
Less than 10 years	5	14.29%
From 11 to 20 years	15	42.86%,
More than 20 years	12	34.29%

 Table 02 shows that, Maximum 15 (42.86%) patient reported the onset of their AV malformation between 11 to 20 years. 12 patient (34.29%) have their lesion after 20 years of age. 5 patients developed the lesion Before 10 years but after birth and only 3 patients (8.57%) got their lesion at birth.

Table 02: Distribution of the patients by the Primary size of lesions (mm*mm) (n=35)

	Primary size of lesions
mm*mm	mm²	Number of Patients (n)	Percentage (%)
10*10	100	8	22.86
10*15	150	1	2.86
10*20	200	3	8.57
15*20	300	2	5.71
20*20	400	6	17.14
20*30	600	10	28.57
30*30	900	3	8.57
30*40	1200	2	5.71
mean±sd	447.14 ± 310.35	35	100

 The primary sizes of the lesion were measured in length*width in mm. Lesion area was calculated in mm². Table 5 shows that the main lesion’s average size was 447.14 mm² with standard deviation of 310.35 and ranged from 100 to 1200 mm². Most of the patients (10, 28.57%) had lesion sized 600 mm². 8 patients (22.86%) smaller sized lesion of 100 mm². 400 mm² sized lesion was observed in 6 patients (17.14%). 3 (8.57%) patients were presented with 200 and 900 mm² sized lesions. 2 patient (5.71%) were documented with larger sized lesion of about 1200 mm². only one patient (2.86%) presented with 150 mm² sized lesion.

Table 03: Number of Sessions of injection

Number of Session	Number of Patients (n)	Percentage (%)
1	9	25.71
2	16	45.71
3	8	22.86
4	2	5.71
Total	35	100

Table 03 shows that highest 4 sessions were needed to complete the treatment. But only 2 patients (5.71%) needed 4 sessions of injection. However, most of the patients were treated with 2 sessions only which was 16 (454.71%) in number. 8 patients (22.86%) were needed 3 sessions for cure and 9 patients (25.71) needed only a single session for cure.

Table 04: Size of lesion during treatment

Size of lesion during treatment (mm²)
	Primary	1st Follow up (4 weeks)	Final Follow up (6 Months)
n	35	35	35
Min	100	30	2
Max	1200	800	30
Mean	447.14	228.28	9.88	p < .00001
SD	310.35	190.47	6.53

The f-ratio value is 37.83885. The p-value is < .00001. The result is significant at p < .05. Table 04 shows the treatment outcome by Comparing of lesion size during stages of treatment. Mean pre-treatment primary lesion size was 447.14 mm² (±310.35). After 10-week follow-up of first injection mean size of the lesion was 228.28 mm² (±190.47) and after final follow up the mean size of the lesion at the completion of the treatment was 9.88 mm² (±6.53

Table 05: Pairwise comparison between treatment sessions.

Pairwise comparison	means	Tukey’s HSD	p
Primary	447.14	218.86	0.00009
1st F/U	228.29
1st F/U	228.29	218.40	0.00010
Final F/U	9.89
Primary	447.14	437.26	0.00000
Final F/U	9.89

The result is significant at p < .05, Pairwise comparison showed that, the difference of lesion size between pretreatment and follow up sessions were significantly different. The differences were statistically significant in all observations. (p< .00001).

Table 06: Respond to treatment

Result                               Number of Patients (n=35)              Percentage %
Excellent	23	65.71%,
Good	10	28.57%
Average	1	2.86%
Poor	1	2.86%

Thirty-five participants participated in this trial. 21 (or 65.71%) of those received excellent results, a3 (28.57%) had good result and only 1 (2.86%) had Average and 1 (2.86%) had poor result. Where, lesion extinguished 100% and symmetrical appearance obtained was graded as Excellent. Definitive (75%) reduction obtained was graded as good response and slight reduction obtained was called Average (50%). Poor response (25% or less) was graded when lesion unchanged or worse.

Table 07: Relation of the size to treatment outcome

Primary Size of lesion	Excellent (n=23)		Good (n=10)		Average (n=1)		Poor (n=1)		N=35
(mm²)	n	%	n	%	n	%	n	%	P value
100	8	34.78	0	0	0	0	0	0
150	1	4.35	0	0	0	0	0	0
200	3	13.04	0	0	0	0	0	0
300	2	8.70	0	0	0	0	0	0
400	6	26.08	0	0	0	0	0	0
600	3	13.04	7	70	0	0	0	0
900	0	0	2	20	1	100	0	0
1200	0	0	1	10	0	0	1	100
Mean	276.08		720		900		1200		< .00001
SD	177.014		209.761		0		0

The f-ratio value is 56.72569. The p-value is < .00001. The result is significant at p < .05. Table 9 shows the relation between primary sizes of lesion to treatment outcomes. The mean (±SD) of the lesion’s primary size was 276.08 (±177.014) mm² who had got excellent retort result. Mean (±SD) primary size of the lesion was 720 (±209.761) mm² who had good outcome. One patient having primary lesion of 900 mm² had average outcome and one patient having primary lesion of 1200 mm² got poor retort. The ANOVA test revealed significant variations in the mean size of the lesions for each outcome.

Table 08: Side effects observed

Side effect	(n)	Percentage (%)
No side effect	15	42.86
Minor complications	20	57.14
Major complications	0	–

Table 08 shows that no side effects were reported in 15 patients (42.86%) and minor side effects were observed in 20 (57.14%) patients. However, no serious or significant side effects were noticed. Minor complications include Induration, Swelling, Pain, Cutaneous or Mucosal blistering, ulceration, ecchymosis, tissue necrosis. Major complications include Anaphylaxis, Systemic embolization of Sclerosant resulting in Thrombophlebitis and /or Thromboembolism, Renal toxicity, Nerve damage, Skin injury.

DISCUSSION

Vascular Malformation is a lesion related to abnormality in the embryonic development and is thus considered a structural anomaly [25]. They are the collection of abnormal vessels with irregular features such as diameter, ramification and density with normal endothelium [26]. They are caused by disturbance in the late stages of angiogenesis. These lesions are often classified as Capillary Malformations, Venous Malformations, Lymphatic Malformations, Arterio-venous Malformations (AVM) and Arterio-venous Fistula (AVF). Vascular malformations are present at birth, may manifest at any time during life and grow proportionately with the individual. According to [27] suggested that vascular malformations have a tendency for re-canalization and recurrence. In such cases, Sclerotherapy may be better than multiple surgical treatments because cosmetic and functional problems following surgical treatment should be carefully considered. Sodium tetradecyl sulphate, 3 % STS [28] has been widely used as sclerosing agent since 1946. In this conducted study among 35 patients, mean age was 23.17 (±16.13) years. Minimum age was 4, whereas maximum age was 63 years.  9 (26%) patients were male and 26 (74%) were female patients. Male: female ratio was 1:2.89. An author [29] showed in their study that, approximately 51% of Vascular Malformation occurs in the head and neck region and male to female ratio is 1:1 in their study. A study conducted [30] on 27 patients reported age range of Benign Vascular Lesions was 11 to 67 years, mean 46.29 and male to female ration was 1:1.4. A author [31], reported 112 cases of vascular malformations of the head and neck ranging from age 1-77 years, mean 27 and male to female ratio was 1:1.5. An author [32] reported patients with cranio facial cavernus malformations ranging from 50 to 47 years, mean= 22 years and male to female ratio was 1:2 In this study most common site of AV malformation ware Tongue and Buccal mucosa, 11 patients (31.43%). Maximum 15 (42.86%) patient reported the onset of their AV malformation between 11 to 20 years. The mean primary size of the lesion was 447.14 mm² with standard deviation of 310.35 and ranged from 100 to 1200 mm². Most of the patients (10, 28.57%) had lesion sized 600 mm². Most of the patients were treated with 2 sessions only which was 16 (454.71%). however, highest 4 sessions were needed to complete the treatment. The conclusions for this study in which the best results were obtained with low volume lesions. A researcher [33] mentioned that permanent obliteration is easier to achieve in small-diameter vessels than in widely dilated channels. A case study reported [34] also mentioned that Sclerotherapy is most effective when the vascular spaces are small or when blood flow is slow. Therefore, it is advisable to begin Sclerotherapy as early as possible once the diagnosis made. In this study mean pre-treatment primary lesion size was 447.14 mm² (±310.35). After 10-week follow-up of first injection mean size of the lesion was 228.28 mm² (±190.47) and after final follow up at the end of the treatment mean size of the lesion was 9.88 mm² (±6.53). Pairwise comparison showed that, the difference of lesion size between pretreatment and follow up sessions were significantly different. Out of 35 patients 21 (65.71%) had excellent result, a3 (28.57%) had good result and only 1 (2.86%) had Average and 1 (2.86%) had poor result. Smaller sized lesion showed better prognosis. A study [35] also observed same response to vascular lesions. Best response was demonstrated clearly in VnM smaller than 2.5 cm due to the fact that the efficacy of the sclerosis depends on the caliber of the feeder vessels and the blood flow. Alternatively, the lower efficacy of sclerotherapy of larger caliber or faster flow lesions was seen as a result of less sclerosant agent making contact with the endothelial cells of the lesional walls [36]. The mean (±SD) primary size of the lesion was 276.08 (±177.014) mm² who had got excellent recovery result. Mean (±SD) primary size of the lesion was 720 (±209.761) mm² who had good outcome. Where, lesion extinguished 100% and symmetrical appearance obtained was graded as Excellent. Definitive (75%) reduction obtained was graded as good response and slight reduction obtained was called Average (50%). Poor response (25% or less) was graded when lesion unchanged or worse. A study [37] used 3 % STS foam to treat 12 patients who had VnM in the head and neck. They found that a single treatment may be adequate for small lesions, but the injections may be safely repeated until a satisfactory result is obtained in large lesions. An author [38] treated a case of a vascular lesion on the ventral surface of the tongue by intralesional injection with 1 ml of 3% sodium tetradecyl sulfate. The lesion regressed completely in a single injection. A study [39] reported two cases that were treated by injecting 1 % STS in the venous malformation of the tongue and left buccal mucosa. After the injection, the lesions were regressed remarkably. Similarly, [40] reported 90–100 % regression in the size of lesions by direct intralesional injection of 3 % STS without radiological guidance into VnM and lymphatic malformations.3% STS is safe for treatment of such cases and usually the volume of 3% STS required is 1/4th the lesion size, i.e., 0.5 ml of 3% STS for each 2 cm of lesion size. Henceforth if the volume of the lesion is small, less amount of sclerosing agent will be injected. Furthermore Choi B. et al. in 2016 highlighted the manufacturer’s instructions of 3% STS. It was revealed that at an instance 0.5–2.0 mL of 3 % STS can be safely injected into a lesion per one dose. In this present reported case, the same protocol was followed. This present study showed no side effects in 15 patients (42.86%) and minor side effects were observed in 20 (57.14%) patients. No severe or major side effects were observed. However, the injection rate and amount must be carefully controlled. Soft-tissue swelling generally increases in the region of thermal formation immediately after the injections. Subsequently, necrosis and inflammation induced by the sclerosis subsides with fibrous tissue formation, culminating in progressive reduction in the lesion size. The complete clinical effect of the therapy may not be evident for several months. Patients and their families must be informed about these expected side effects and outcomes so the patient has realistic expectations. An author [41] encountered no complications during the sclero therapeutic session in his study carried out on a series of 8 patients. Although marked swelling and pain were the most common complication (55%) immediately after the treatment. Hematuria was seen twice in one patient (10) immediately after the procedure. The advantages of sclerotherapy are that it is an easily available, simple, non-invasive, economical, safe, reliable and effective drug with minimal side effects, Causes minimal discomfort to the patient, negligible blood loss. Moreover, there is no requirement of local anesthesia or postoperative dressings or any specific care. The patient can resume his daily activities immediately. The side effects encountered in all patients were pain and edema after injection. Four patients had superficial ulceration which healed without scarring. One patient had ecchymosis followed by tissue necrosis (Nicaolau syndrome) which healed after a month. Contraindications of sclerotherapy are uncontrolled diabetic patients, in areas of secondary infection and pregnant women. Perhaps, our failure to statistically support correlation of all the parameters with the outcome of the sclerotherapy can be ascribed to small size of our samples. Interpretation of the findings must also take into account the fact that Vascular Anomalies evolve and that some patients in this study will require further Sclerotherapy. However, effect of sclerotherapy with 3% Sodium tetradecyl sulphate in the treatment of vascular lesions is satisfactory.

4. CONCLUSIONS

Interpretation of the findings shows that Vascular Anomalies evolve and that some patients in this study will require further Sclerotherapy. However, effect of sclerotherapy with 3% Sodium tetradecyl sulphate in the treatment of vascular lesions is satisfactory.  This study concludes that as an alternative treatment option for managing oral and peri-oral vascular lesions, sclerotherapy with direct intralesional injection of 3 % STS solution is minimally invasive, safe, and effective therapy that can be done in an office procedure. Smaller lesions have a more favorable response with minor complications. Careful planning, case selection, and evaluation are essential to minimizing unwarranted risks and issues. Furthermore, studies on large number of patients are warranted to confirm the efficacy of STS over other sclerotic agents.  Long term follow-up results need to observe.

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