Comparative study between nail retraining with gauze bandaging and the nail remodeling with acrylics as a conservative treatment for stage I and IIa onychocryptosis

Onychocryptosis is one of the most prevalent onychopathies, being a frequent reason for consultation in podiatric clinical practice. Conservative treatments are the first therapeutic choice, with nail remodeling using clotrimazole gel emerging as an alternative, although its medium‐term effectiveness is unknown. The objective of this study was therefore to compare the efficacy of the technique of nail retraining using gauze bandaging with that of nail remodeling for the conservative treatment of stage I and IIA onychocryptosis.

nail plate. 1 In addition, various other factors have been observed, such as a pronated foot, deviation of the first metatarsal segment, 2 or the use of certain drugs such as oral retinoids 3,4 among others. 5,6 In stages I or IIa of the pathology, conservative treatments are effective at reducing painful processes, 7 and are now the first therapeutic choice, depending on the diagnosis, severity of the condition, prognosis, and physical condition of the patient. More severe stages of the pathology, such as IIb, III, or IV, require surgical treatment for their definitive resolution, 1 that consists in the elimination of the affected nail plate and their germinal matrix. 8 The purpose of conservative treatments is to retrain nail growth to prevent the new nail from injuring periungual tissue. These conservative treatments range from simply cutting off the affected portion of nail, 9 the gradual separation of the nail plate with tape, 10 dental floss, 11 cotton, or gauze, 12 application of plastic or metallic plates with molecular memory toward horizontality, 13 to remodeling the nail plate with resins. 14 Nonetheless, the effectiveness of these treatments is restricted since, at 2-3 months, there is around 8.2%-28% recurrence 12 depending on the expertise of the professional who applies it, and strict adherence to the treatment on the part of the patient is necessary due to the very many subsequent visits that are required. Recurrences of the deformity are frequent and require surgical treatment as a definitive solution.
A novel treatment has emerged in recent years with the use of a 1% clotrimazole gel. An acrylic prosthesis in the shape of the original nail plate is applied in order to preserve the lateral fold where the lesion appears. The advantages of this treatment over previous treatments are as follows: its ease of application in a single-phase format, no mixing is required, no handling of toxic components is involved (as instead is the case for some acrylics that are accompanied by cyanoacrylate), it is cheaper than plastic or metallic orthonyxia, and no anesthesia is required (as would be the case with a tube or cannula). There have as yet been no studies to support its effectiveness. The present study is based on the hypothesis that the result of reconstruction with the gel nail will be better in terms of pain, the presence of inflammation or infection, patient satisfaction, and recurrence. Its objective was to evaluate the efficacy of clotrimazole gel treatment by comparing it with the standard conservative treatment of spiculectomy and gauze as control.

| Participants
The sample consisted of 20 patients (16 women and 4 men, mean age 24.8 ± 5.7 years) with onychocryptosis. The study was carried out at the University of Valencia and the Aquilesia Podiatric Centre. The patients participated voluntarily in the study, signing their informed consent. The study complied with the requirements of the Helsinki declaration, being approved by the Bioethics and Biosafety committee (ID: 198A//2020) and registered at Clini calTr ials.gov with the number NCT05214586. The inclusion criterion for participation in the study was as follows: (1) stage I or IIA onychocryptosis of the hallux according to the Mozena classification. 15 The exclusion criteria were as follows: patients who (1) did not allow clinical follow-up of the evolution of the pathology, (2) presented deforming nail pathologies, or (3) had undergone surgery for onychocryptosis.

| Temporal period
Sample selection was carried out in February 2022 by consecutive inclusion of the patients who attended for consultation. A randomization process was carried out by order of visit, with the first 10 patients (mean age 24.8 ± 4.5) undergoing the nail retraining technique with gauze bandaging, and the following 10 (mean age 25.6 ± 6.8) the nail remodeling technique.

| Procedure
The

| Follow-up
The follow-up of the two groups of subjects was carried out in April and May 2022, 3 months after the first visit. The subjects were informed that they were not to cut their nails by themselves during the period. In the case of appearance of symptoms associated with onychocryptosis, the subjects had to contact the researcher as soon as possible. They would be given an appointment for consultation to proceed to a new spiculectomy and perform the conservative technique corresponding to their study group. In this follow-up, a new VAS measurement of the pain was made, as well as noting any inflammatory or infectious symptoms. Patient satisfaction with the treatment performed was assessed on a scale from 0 to 10.

| Statistical analysis
The variables were recurrence, inflammation, or infection after the intervention (Yes/No). A chi-squared test was used for the comparison of these variables. The quantitative variables were pain after the intervention and degree of patient satisfaction. First, the Shapiro-Wilk test was performed to determine the fit of the data to normality. The data did not present a normal distribution (p = 0.023), so that a Mann-Whitney U-test was performed. The pre-and postintervention frequencies were compared using a chi-squared test.

| RE SULTS
In each of the two groups (retraining and remodeling), seven patients presented stage I onychocryptosis and three patients stage  (Table 1).
Before the intervention, the patients in the retraining group presented pain of 6.7 ± 1.9 compared with 6.8 ± 1.6 in the remodeling group, with there being no significant difference between the two (p = 0.900). After the 3-month follow-up period, seven patients in the retraining group presented recurrence of onychocryptosis, while only one patient in the remodeling group presented recurrence, the difference between the two being statistically significant (p = 0.006, Table 2). The patients in the retraining group presented more inflammation than the remodeling group (p = 0.019, Table 2).
There was a greater degree of satisfaction in the remodeling group than in the retraining group (8.6 ± 1.2 vs. 4.7 ± 2.11, p < 0.001).
Pain in the remodeling group was significantly less than in the retraining group (p = 0.001, Table 3). The hypothesis of this study was that the technique of nail remodeling is more effective than that of nail retraining with gauze bandaging. An inferential analysis made it possible to verify that there are indeed significant differences between the two techniques since there were more cases of recurrence observed at the follow-up visit in the nail retraining group than in the remodeling group. An explanation could be that in nail retraining the gauze bandaging is expelled as the days go by, while the remodeling gel has longer durability and, if it is to be removed, this must be done by the podiatry professional. In our case, the 1% clotrimazole contained in the treatment is not a possible treatment for onychomycosis due the difficult trans-nail drug delivery, 23 but a method to protect the prosthesis from fungi.
Some authors put the recurrence rate of nail remodeling at between 8.2% 22 and 21.74%, compared with 91.67% in the retraining group. 7 Hence, one observes that the recurrence rate of these studies is very similar to that of the present study, which is around 10%.
The pre-intervention inflammation, pain, and infection correspond to the usual clinical picture accompanying onychocryptosis of stage I and IIA according to the Mozena classification. After the intervention, inflammation is present in just 10% of the subjects in the nail remodeling group compared with 60% in the retraining group.
Therefore, the symptomatology after follow-up is more pronounced in the retraining group, which could be related to the possible appearance of recurrence. This reduction in symptoms at 3 months is consistent with other authors, who found a reduction in pain in the first week after the application of the gel nail. 22

TA B L E 3
Results of the degree of satisfaction and pain (overall and by groups)