Dermatology: Practical and Conceptual Original Article | Dermatol Pract Concept. 2023;13(2):e2023083 1 Evaluation of Flexibility and Thickness of Cleft Lip Scars After Treatment with Microneedling Technique: a Cohort Trial Mohamad Alghazzawi1, Yasser Almodalal2 1 Department of Oral and maxillofacial surgery, University of Damascus Dental School, Damascus, Syria 2 Oral and maxillofacial surgery, University of Damascus Dental School, Damascus, Syria Key words: cleft lip, scar, scar management, scar treatment, microneedling Citation: Alghazzawi M, Almodalal Y. Evaluation of Flexibility and Thickness of Cleft Lip Scars After Treatment with Microneedling Technique: a Cohort Trial. Dermatol Pract Concept. 2023;13(2):e2023083. DOI: https://doi.org/10.5826/dpc.1302a83 Accepted: September 20, 2022; Published: April 2023 Copyright: ©2023 Alghazzawi et al. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (BY-NC-4.0), https://creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original authors and source are credited. Funding: None. Competing Interests: None. Authorship: All authors have contributed significantly to this publication. Corresponding Author: Mohamad Alghazzawi, PhD student, Department of Oral and maxillofacial surgery, University of Damascus Dental School, Damascus, Syria. E-mail: d.ghazawy86@gmail.com Mobile: +963988359129 Introduction: The early surgical treatment of the cleft lip led to a postoperative scar formation which may affect the physiological and psychological aspects of the patient. Objectives: Evaluating the improvement rate of thescar flexibility and thickness of the cleft lip scar after treatment with the microneedling. Methods: Sixteen patients (12 females and 4 males), aged 16-30 years who had a cleft lip scare were included in the current study. All patients suffered from a visible defective scar in the upper cleft lip. All patients were treated with a microneedling pen device combined with topical application of oil-based hyaluronic acid. The procedure was performed in 4 sessions with 3-week intervals between sessions. The scars were assessed by the patient and an external observer using the Patient and Observer Scar Assessment Scale. Results: Thickness of the scar was improved according to the patient and observer opinions (67.28% and 61.55% respectively). Flexibility was improved according to the patient observer opinion (65.57% and 60.25% respectively). Conclusions: Microneedling treatment can be considered as an effective method for the treatment of the defective scars resulting from the cleft lip plastic surgery. The microneedling technique is a simple, easy, safe, non-invasive, and low-cost procedure. ABSTRACT 2 Original Article | Dermatol Pract Concept. 2023;13(2):e2023083 Introduction The cleft lip is a congenital development defect caused by the lack of connection of the upper lip tissues during the embryonic period [1]. The cleft lip defect has an influence on the normal facial appearance and functions such as feeding and speech, which affect the child psychosocial development negatively [2]. The surgical treatment of the cleft lip allows to secure continuity of the lip tissues. It is usually performed at the age of 2 to 6 months. There are many surgical tech- niques for the primary repair of cleft lip. Unfortunately, these techniques are associated with a postoperative scar formation [3]. The scar often undergoes contracture and hypertrophy, due to the repeated movements related to facial expressions and basic life activities, which adversely affect the postoper- ative wound healing process [4]. The scar tends to be raised above the skin surface and is hyperpigmented more than the normal skin [5]. The scar tissue leads to the creation of some secondary deformities, such as deformed philtrum, Cupid’s bow asymmetry, tight upper lip, whistle deformity, and ir- regularities in the function of orbicularis oris muscle [6,7]. The scar of the upper lip may restrict the growth and devel- opment of the maxilla, leading to a skeletal Class III maloc- clusion [8]. A mature cutaneous scar usually consists of a large amount of collagen fibers (80%-90% type I, the rest type III) [9]. The collagen fibers within the scar are arranged in bun- dles parallel to the surface of the skin. On the other hand, the collagen fibers in the normal skin are arranged in a nonpar- allel ‘‘basket-weave’’ orientation [10]. The basement mem- brane of the epidermis that develops over the scar tissue is flatter than the normal skin tissue because the scar does not contain the rete pegs that penetrate the dermis [9]. In addi- tion, the cutaneous scar does not contain dermal appendages such as hair follicles, sebaceous glands, and stem cells [5,11]. The extracellular matrix (ECM) of the scar tissue contains less elastin than normal skin, resulting in decreased elasticity in the scar [12]. Clinically and cosmetically, a favorable scar has an im- perceptible fine line and is parallel to skin creases and folds, similar in color and contour to the surrounding skin, and within the level of the skin [13]. Many methods were proposed for treating the scar of cleft lip including surgery, steroids injection, botulinum toxin Type A injection, silicone gel sheeting, fractional ablative la- sers, and microneedling [14,15]. The microneedling procedure is also called the Percuta- neous Needle Collagen Induction Technique (PCI). The PCI was firstly introduced by Orentreich and Orentreich [16] who used the needles in order to stimulate the production of collagen in the treatment of depressed scars and wrinkles. The mechanism of action is mainly based on the rupture and removal of the damaged subepidermal collagen followed by substitution for new collagen and elastin fibers. The microneedling treatment stimulates collagen produc- tion without removing the epidermis, and the tissue regener- ation time is commonly shorter than the ablative techniques, which substantially reduces the risk of adverse effects when benchmarked. As well, the skin becomes more resistant and thicker [15]. Objectives The current study aimed to evaluate the efficacy of micronee- dling in improving the flexibility and thickness of the cleft lip scar as one of the conservative techniques in the manage- ment of postoperative scars. Methods Trial Design This study was a cohort study. The current trial was achieved at the Department of Maxillofacial Surgery at the Faculty of Dentistry, Damascus university, Syria between August 2019 and September 2021. Ethical approval was obtained from the Local Ethics Research Committee at the Uni- versity of Damascus, Dental School (Reference Number: 25223102017-DEN). Participants and Eligibility Criteria The sample consisted of 18 scars in 16 patients (14 unilateral clefts, 2 bilateral clefts). The distribution was as following: 2 males (3 scars) and 14 females (15 scars) of cleft lip and palate patients who completed their lip repair surgeries. The age of patients ranged from 16-35 years. All patients had a visible defective scar and the desire to perform cosmetic pro- cedures in order to improve the general appearance of the lip. All individuals were able to follow the stages of treatment. Microneedling Intervention The automated microneedling tchnique was performed us- ing an automated micro needling Dermapen (Beijing HYE Technology Co) which is considered an advanced technology for vertical pricking of the skin through several needles that puncture the skin with an automatic percussion function. The device consists of a handpiece, equipped with an electric motor and a head consisting of 12 needles, 33 gauges are attached to a disposable rod (Figure 1). The needles move up and down from 0.25 mm to 2.5 mm entering depth. The speed of movements ranges from 1 to 7 pricks per second. The entry depth and speed are ad- justed depending on the scare area via private keys. Original Article | Dermatol Pract Concept. 2023;13(2):e2023083 3 The treatment was divided into 4 sessions with an in- terval of 3 weeks. The surface of scar was cleaned well with 0.10 ml Hexamidine solution, then a local anesthetic cream (EMLA) was applied for 20 minutes. After that an oil-based hyaluronic substance with a concentration of 3.5% and formulated from a mixture of hyaluronic acid of non-cross-linked biotechnological origin was applied to the skin surface. The dermapen was applied to the scar with a prick depth of 2-2.5 mm and speed of 5 pricks per second, depending on the device instructions for the treatment of scars. Finally, the surface of the scar was cleaned with a piece of sterilized gauze soaked in saline solution and a steri-strip bandage was applied (Figures 2 and 3). Additional images for clinical cases were treated in the current study have been included in Figures 4 and 5. All patients were informed that a redness can be seen af- ter treatment and may last for 2-3 days after the procedure. All of them were also asked to apply a cold compress to the workplace for the first couple of hours. Outcome Assessment The thickness and flexibility of the cleft scar were assessed before treatment and one month after the last treatment ses- sion by both the patient and three external observers from the Oral and Maxillofacial Surgery Residents using the Pa- tient and Observer Scar Assessment Scale (POSAS) [17]. Comparisons have been made between the baseline data (be- fore treatment) and after one month of treatment. Thickness: the distance between the surface of the scar and the adjacent skin surface. Flexibility: It is measured by the flexibility of the scar be- tween the index finger and thumb. The evaluated items consist of a 10-point scale where 1 indicates the best scar that matches the adjacent healthy skin and the number increases as the scar worsens as 10 indicates the worst scar.Figure 1. The automated microneedling Dermapen. Figure 2. (A) Topical anesthesia; (B) Application of hyaluronic acid; (C) The microneedling process; (D) Steri-strip dressing. 4 Original Article | Dermatol Pract Concept. 2023;13(2):e2023083 Figure 4. Clinical case 2. (A) Before treatment; (B) Immediately after microneedling; (C) After 1 month of the final microneedling process. Figure 3. Clinical case 1. (A) Before treatment; (B) Immediately after microneedling; (C) After 1 month of the final microneedling process. Figure 5. Clinical case 3. (A) Before treatment; (B) Immediately after microneedling; (C) After 1 month of the final microneedling process. Statistical Analysis All statistical analyses were performed using SPSS software (version 20; IBM)). The paired sample t-test was applied to assess the differences in the thickness and flexibility of the cleft lip scar before and after treatment with microneedling. Results The percentage of improvement for both the thickness and elasticity of the scar was assessed, according to the opinions of both the patient and the observers with the POSAS, ac- cording to the following equation: The Improvement percentage = (the amount of the im- provement after treatment / pre-operative rate) * 100 (Table 1). The thickness of the scar was improved according to the patient’s and observer’s opinions (67.28% and 61.55% respectively). Flexibility was improved according to the patient’s and observer’s opinion (65.57% and 60.25% respectively). The thickness and flexibility were improved signifi- cantly after the PCI according to the patient and outer ob- server reports (P < 0.05) (Table 2). According to the patient opinion, the mean improvement rate was 4.899 and 5.791 for thickness and flexibility of the scare respectively. Ac- cording to the observer opinion the mean improvement rate was 4.548 and 4.963 for thickness and flexibility of the scar respectively. Conclusions Aesthetics is a science, practice and experience. It is develop- ing rapidly due to the entry of new technologies and devices Original Article | Dermatol Pract Concept. 2023;13(2):e2023083 5 scare. In the current trial, the microneedling treatment and hyaluronic acid application were combined together. Lee et  al combined the microneedling treatment with a human stem cell conditioned medium [20]. The same findings were observed by Aust et al who conducted a study to evaluate the effectiveness of microneedling in improving the appearance of post-burn scars [21]. Finally, the lack of number of the patients in the current study and the short duration of the follow-up period are the main limitations of this trial. In conclusion, the cleft lip scar management should be considered as a principal element of the treatment plan in cleft patients. In the case of patients with secondary cleft lip deformities, surgical correcting methods should be consid- ered taking into account that any surgical intervention leads to new scars formation. Therefore, it is necessary to imple- ment nonsurgical methods to prevent the scar hypertrophy. Microneedling therapy can be considered an effective mo- dality for the treatment of surgical cleft lip scars in patients. Microneedling treatment is a simple and cost-effective tech- nique in the treatment of the facial scars. Damascus Dental School (Reference Number: 25223102017-DEN). References 1. Silva HPVD, Arruda TTS, Souza KSC, et  al. Risk factors and comorbidities in Brazilian patients with orofacial clefts. Braz Oral Res. 2018;32: e24. DOI: 10.1590/1807-3107bor-2018. vol32.0024. PMID: 29641641. in this field. On the other hand, aesthetics has a principal role in people social and professional life. This study was conducted to evaluate the efficacy of mi- croneedling with hyaluronic acid therapy in the management of postoperative cleft lip scars resulting from primary and secondary repair surgeries in cleft lip patients. The elastic- ity and thickness of the scar were assessed according to the opinion of the patient and external observers. In the current study, the flexibility of the scar was improved to reach as close as the surrounding natural skin with an av- erage improvement percentage of 65.57% and 60.25% for the patient and observer respectively. The same findings were observed in the thickness of scar. The level of scare (thickness) also improved to become very similar to the surrounding nat- ural skin with an average improvement percentage of 67.28% and 61.55% for patient and observer respectively. These results were similar to what was reported by Lakshmi et al who evaluated the PCI efficacy in treating the scars resulting from trauma, surgery, or cleft lip. Lakshmi et al reported that the scar improvement rate after micronee- dling was 100% [18]. This percentage was higher than the current results. This dissimilarity may be due to the involve- ment of many types of scares not only the scars resulting from postoperative clef lip scars. El-Domyati et al demonstrated that the treatment with microneedles enhances the growth of type I, III, and VII col- lagen and tropoelastin [19]. Lee et al found that the microneedling combined with other substances is effective in the enhancement of cleft lip Table 1. The descriptive values in both the thickness and elasticity of the scar. Studied Item The Resident Before After The amount of improvementa improvement percentage Thickness Patient 7.281 2.382 -4.899 67.28% Observer 7.389 2.841 -4.548 61.55% Flexibility Patient 8.831 3.040 -5.791 65.57% Observer 8.237 3.274 -4.963 60.25% a The amount of improvement = post-operative rate value – pre-operative rate value. Table 2. Comparison of the thickness and flexibility of the lip scar before and after the microneedling operation. Variable Assessor Time N Mean ± SD T-test value P valueb Thickness Patient Before 18 7.28±1.36 15.149 <0.001a After 18 2.38±1.17 Observer Before 18 7.38±0.99 23.795 <0.001a After 18 2.84±0.79 Flexibility Patient Before 18 8.83±1.58 5.57 <0.001a After 18 3.04±1.14 Observer Before 18 8.23±0.74 30.233 <0.001a After 18 3.27±0.67 a P <0.05 significant difference; b paired t test was applied SD = standard deviation. 6 Original Article | Dermatol Pract Concept. 2023;13(2):e2023083 2. Chen G, Li MX, Wang HX, et al. 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