Diode laser surgery versus scalpel surgery in the treatment of fibrous hyperplasia: a randomized clinical trial

Abstract

Fibrous hyperplasia is treated by surgical incision using a scalpel, together with removal of the source of chronic trauma. However, scalpel techniques do not provide the haemostasis that is necessary when dealing with highly vascular tissues. Diode laser surgery can be used in the management of oral tissues due to its high absorption by water and haemoglobin, and has provided good results in both periodontal surgery and oral lesions. The aim of the present study was to compare the effects of diode laser surgery to those of the conventional technique in patients with fibrous hyperplasia. A randomized clinical trial was performed in which surgical and postoperative evaluations were analyzed. On comparison of the laser-treated (study group) patients to those treated with a scalpel (control group), significant differences were observed in the duration of surgery and the use of analgesic medications. Over a 3-week period, clinical healing of the postoperative wound was significantly faster in the control group as compared to the study group. In conclusion, diode laser surgery proved to be more effective and less invasive when compared to scalpel surgery in the management of fibrous hyperplasia. However, wound healing proved to be faster when using scalpel surgery.

Fibrous hyperplasia is a chronic low-grade irritation occurring as a consequence of ill-fitting dentures. Fibrous hyperplasia is frequently the result of the resorption of the alveolar ridge in such a way that the denture moves further into the vestibular mucosa, leading to fibrous hyperplasia that proliferates over the flange. Additionally, parafunctional habits can also induce a focal fibrous hyperplasia.

Fibrous hyperplasia is a frequent oral lesion that affects 5–16.7% of the population. It commonly appears as a small-sized, painless lesion with a fibrous to flaccid consistency that is pale to erythematous in colour, and can be found in any part of the oral cavity. Fibrous hyperplasia occurs as a result of chronic irritation, and when the source of trauma is removed, the lesion commonly decreases in size or regresses.

Conventionally, fibrous hyperplasia is treated by surgical excision using a scalpel, together with the removal of chronic traumatic factors. Scalpels have been used for many years due to their ease of use, accuracy, and minimal damage to the surrounding tissues. However, haemostasis of the surgical wound can be difficult, especially for patients with haemorrhagic disorders or those on anti-thrombotic therapy, without a suturing of the wound borders. In the management of fibrous hyperplasia, haemostatic problems can be controlled by the use of electrocautery, which provides enhanced haemostasis by sealing the blood vessels before cutting. However, the cutting performance can be reduced by muscle fasciculation, while wound healing is delayed by the extensive thermal damage caused when compared to scalpel surgery. It is important to consider that a significant loss of sulcus depth and/or full elimination of the vestibule can occur in cases induced by ill-fitting dentures when suturing is performed on the wound borders.

Surgical laser systems have been applied in the treatment of oral lesions. The main types are: (1) potassium–titanium–phosphorous (KTP), (2) neodymium–yttrium–aluminium–garnet (Nd:YAG), (3) carbon dioxide (CO 2 ), and (4) diode lasers with semiconductors. Diode laser systems are portable, compact, and cost-effective when compared to other high-power lasers. Diode lasers have a wavelength of between 805 and 980 nm, which can be used in continuous or pulsed mode, depending on the clinical requirement, using an optical fibre with or without contact. Diode laser surgery is often used in the management of oral tissues due to the high absorption by water and haemoglobin, and has provided sound results in periodontal surgery, tissue alterations related to orthodontic treatment, and oral lesions.

Considering that (1) diode laser surgery appears to be a good option for the treatment of oral diseases, including fibrous hyperplasia, (2) only a few clinical studies have been published, and (3) the conventional treatment using scalpels can lead to clinical complications, the aim of the present study was to compare the effects of diode laser surgery with conventional techniques using scalpels.

Patients and methods

Patients and study design

Patients were recruited consecutively from the oral medicine clinic of the study university in Belo Horizonte, Brazil, from February to October 2013. The cases included 38 patients with fibrous hyperplasia caused either by dentures or by parafunctional habits. The sample size was calculated based on dependent variables (postoperative pain and postoperative functional alterations) and analyzed considering a 95% confidence interval (CI). The parameters used to perform the sample size calculation were identified from studies with a similar design published in the literature. Limited-sized lesions with a flaccid to fibrous consistency that were sessile or had a pedicle, that were pale to erythematous in colour, and that were associated with dentures or parafunctional habits, were included in this study. Dentures were removed 2 weeks prior to treatment to eliminate inflammation and/or chronic pain. Patients currently using anti-inflammatory or analgesic medications were excluded. The lesions were measured in their largest diameter with a millimetre rule. A randomized clinical trial was carried out and patients were divided into two groups. A computer-generated list of random numbers was used to allocate subjects to the groups, considering a randomization ratio of 1:1 (Microsoft Office Excel software, 2007). This study was approved by the human research ethics committee of the study institution and was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement. Patients signed a statement of informed consent prior to their inclusion in this study.

Surgical procedures

The control group (conventional technique using a scalpel) consisted of 19 patients. For these patients, infiltrative anaesthesia with 2% lidocaine and adrenaline at 1:100,000 (DFL Indústria e Comércio S.A., Rio de Janeiro, Brazil) was applied. Following this, the fibrous hyperplasia was removed through incisions made using a number 15C surgical blade, with the aid of mosquito forceps to provide a slight traction of the lesions. The surgical procedures were performed under conditions of continuous bleeding, which was controlled by applying a pressure dressing. Continuous suturing of the wound borders was performed to control the bleeding and did not lead to a decrease in the buccal vestibule ( Fig. 1 ).

Fig. 1
Clinical aspects of fibrous hyperplasia following scalpel surgery. (A) Fibrous hyperplasia caused by dentures, with a mucosa-like colour and measuring 40 mm in largest diameter. (B) Postoperative aspect of the wound after 7 days with continuous sutures; an ulcer of 30 mm covered by a pseudomembrane can be observed. (C) Postoperative aspect of the wound after 21 days. (D) Complete healing of the wound observed after 28 days; a significant mucosal scar is present.

The study group (diode laser technique) consisted of 17 patients. For these patients, topical anaesthesia alone was first applied to the lesions (EMLA; AstraZeneca do Brasil Ltda, São Paulo, Brazil). Infiltrative anaesthesia with 2% lidocaine and adrenaline at 1:100,000 (DFL Indústria e Comércio S.A.) was applied if the patient complained of any kind of pain. Slight traction of the lesion using mosquito forceps was performed to facilitate the application of the diode laser incision. Suturing was not performed ( Fig. 2 ). While the laser was in use, an assistant was asked to hold the suction tip near the region of the surgery. Protective glasses were worn by both the professionals and the patient.

Fig. 2
Clinical aspects of fibrous hyperplasia following diode laser surgery. (A) Fibrous hyperplasia induced by dentures, with a mucosa-like colour and measuring 30 mm in largest diameter. (B) Immediate post-surgical aspect of the wound treated with diode laser surgery; excellent haemostasis can be observed. (C) The 30-mm surgical specimen was sent for histopathological analysis. (D) Postoperative aspect of the wound after 7 days; an ulcer of 30 mm in size covered by a pseudomembrane can be observed. (E) Postoperative aspect of the wound after 15 days; an accelerated wound healing process can be observed. (F) Complete healing of the wound after 21 days; there has been no decrease in vestibule after clinical healing and a minimal mucosal scar is present.

Surgical specimens obtained from both groups were fixed in 10% buffered formalin and sent for histopathological analysis.

Laser parameters

Laser irradiation was performed using an 808 nm diode laser (Thera Lase Surgery; DMC Ltda, São Carlos, Brazil), with an optical fibre of 600 μm, at a potency of 2.0–3.5 W (average 2.96 W) in continuous-wave mode.

Surgical and postoperative evaluations

The following parameters were assessed for both surgical techniques: (1) type of anaesthesia, (2) duration of surgery, (3) bleeding, (4) oedema, (5) secondary infection, (6) postoperative pain, (7) analgesic use, (8) postoperative functional alterations, i.e., alterations in eating and speech, (9) clinical healing, and (10) patient satisfaction.

The patients were asked to rate the degree of pain and postoperative functional alterations (discomfort during eating and speech) on separate 10-cm horizontal visual analogue scales (VAS). The left endpoint of the pain scale was designated as ‘no pain’, while the right endpoint was marked as ‘worst pain imaginable’. The end-points of the scales for the degree of discomfort during eating and speech were marked as ‘no discomfort’ on the left side and ‘worst discomfort imaginable’ on the right side. The patients were asked to mark the position between the two endpoints that best described their personal perception of the degree of pain and discomfort during eating and speech that they had experienced on postoperative days 1 and 7. The mark placed by the patient was measured to the nearest centimetre; thus the scores for the degree of pain and functional complications were between 0 and 10. A single operator recorded these scores on postoperative days 1 and 7.

All patients were instructed to use the same analgesic medication containing paracetamol (750 mg, four times/day) if needed to alleviate the pain, and analgesic usage was subsequently analyzed. In addition, the patients were asked whether or not oedema was present. Secondary infection was investigated by assessing the presence or absence of local exudation and fever. Bleeding during the postoperative period was recorded as present or absent. Clinical healing of the postoperative wounds was assessed at the weekly follow-ups; these were measured with a millimetre ruler in their largest diameter until they had healed completely. The duration of surgery was measured in minutes with a digital chronometer.

Patient satisfaction with the treatment was evaluated after complete clinical healing of the postsurgical wounds, with complete epithelialization. A VAS was applied to establish the degree of satisfaction: 0 = totally unsatisfied and 10 = totally satisfied.

Postsurgical care

During the postsurgical period, all patients practised special oral hygiene care and avoided hot, hard, and/or acid foods. Patients were instructed not to ingest any form of analgesic medication during the postsurgical period, except in the case of unbearable pain.

Statistical analysis

The data analysis was performed using SPSS for Windows, version 17.0 (SPSS Inc., Chicago, IL, USA); this analysis included descriptive statistics and association tests for comparisons between the two groups. The Shapiro–Wilk test was used to evaluate the distribution of numerical variables (normal or non-normal), following which parametric or non-parametric tests, as appropriate, were applied. The Mann–Whitney U -test was used to compare numerical variables, while the χ 2 test or Fisher’s exact test was applied for categorical variables. The Student’s t -test was used to compare the duration of surgery due to the normal distribution of the data. The time to healing (in days) of the postoperative wounds was displayed by means of the Kaplan–Meier method. The results of the Kaplan–Meier plots were compared by applying the log rank test. The level of significance for statistical differences was set at P ≤ 0.05.

Results

A total of 38 patients agreed to participate in this trial. However, the lesions of two patients regressed after removing their dentures and a further two patients did not participate in all postoperative stages. Therefore, 34 patients were analyzed in this study ( Fig. 3 ); 27 (79.4%) were females and seven (20.6%) were males, and they ranged in age from 12 to 80 years (mean 58.1 years). The fibrous hyperplasia was caused by dentures in 26 of the patients (76.5%); focal fibrous hyperplasia was found in eight patients (23.5%). The size of the fibrous hyperplasia ranged from 5 to 90 mm (mean 31.47 mm) in the study group ( Fig. 2 ), and from 8 to 60 mm (mean 24.18 mm) in the control group ( Fig. 1 ). No statistically significant difference in the sizes of the lesions was found when comparing the two groups ( P = 0.06).

Fig. 3
Study flow diagram.

The duration of surgery was shorter in the study group, but these patients reported more oedema. More analgesic medicine was consumed by patients in the control group, but the time to clinical healing of the postoperative wounds was shorter in this group. These differences were statistically significant ( Table 1 ). Clinical healing of the postoperative wounds was statistically faster in the control group in the third week. No significant differences between the two groups were found regarding subjective pain, postoperative functional alterations (eating and speech), bleeding, and type of anaesthesia ( Table 1 ). No secondary infection was observed in either group, and all patients in both groups reported total satisfaction with the treatment. Additionally, the time to healing was compared between the groups, demonstrating that less time was required for healing of the postoperative wounds in the control group ( Table 1 , Fig. 4 ).

Table 1
Summary and statistical analysis of the parameters evaluated in the study and control groups.
Parameters Study group Control group P -value
Anaesthesia, n (%)
Topical 4 (12%) 0 0.10 *
Infiltrative 13 (38%) 17 (50%)
Duration of surgery, min (mean ± SD) 5.4 ± 3.6 7.8 ± 3.2 0.04
Oedema, n (%)
Oedema 12 (71%) 6 (35%) 0.03
No oedema 5 (29%) 11 (65%)
Pain
Pain day 1 (range; median) 0–9; 0 0–8; 2 0.38 §
Pain day 7 (range; median) 0–6; 0 0–7; 0 0.42 §
Analgesic usage, n (%)
Yes 6 (35%) 13 (76%) 0.01
No 11 (65%) 4 (24%)
Eating
Eating day 1 (range; median) 0–9; 0 0–8; 0 0.79 §
Eating day 7 (range; median) 0–7; 0 0–6; 0 0.60 §
Speech
Speech day 1 (range; median) 0–1; 1 0–9; 0 0.47 §
Speech day 7 (range; median) 0–5; 0 0–6; 0 0.22 §
Clinical healing of the postoperative wound, days (mean ± SD) 24.29 ± 4.37 21.41 ± 1.69 0.01
Size of the postoperative wound, mm
Week 1 (range; median) 5–90; 20 5–50; 20 0.54 §
Week 2 (range; median) 0–70; 10 0–30; 10 0.06 §
Week 3 (range; median) 0–50; 0 0–10; 0 0.01 §
Week 4 (range; median) 0–20; 0 0 0.31 §
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Jan 17, 2018 | Posted by in Oral and Maxillofacial Surgery | Comments Off on Diode laser surgery versus scalpel surgery in the treatment of fibrous hyperplasia: a randomized clinical trial
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