Diode Laser-Assisted Frenectomy with Hyaluronic Acid

This study was a prospective, examiner-blind, randomized, and controlled clinical trial. The local ethics committee approved the study protocol (Approval 2019/220). The clinical phases of the study were performed at the Department of the Periodontology Clinic between August 2019 and May 2021. The conducted research followed the ethical principles outlined in the Declaration of Helsinki. G-Power (version 3.1; Informer Tech Inc., Germany) was used to determine the number of research participants [19 (link)]. It was determined that each group must have a minimum of 16 individuals to achieve 95% power at a 5% significance level. To accommodate potential dropouts and non-compliance, 96 participants were recruited. The randomization sequence was generated using an online computer-based tool (www.random.org). The allocation of participants was independently conducted by individuals designated as OD, ensuring the concealment of allocation. Ninety-six pediatric patients (females, 50 and males, 46) aged 8–14 years were randomly divided into four groups: (1) conventional labial frenectomy with 0.6% topically administered HA (CFH, n = 24); (2) conventional labial frenectomy with placebo gel (CFP, n = 24); (3) labial frenectomy performed by diode laser with 0.6% topically administered HA (DLH, n = 24); and (4) labial frenectomy performed by diode laser with placebo gel (n = 24; Fig. 1).Fig. 1

CONSORT diagram of the flow chart

Systemically healthy and non-medicated individuals (for at least 6 months) with gingival (n = 31; 32.29%), papillary (n = 39; 40.62%), and papillary penetrating (n = 26; 27.08%) labial frenulum attachments were included in the study. The parents signed a written informed consent form for their children’s participation in this study, and the children were given a brief description of the process. The study included frenectomy treatments performed by researchers SSAD and CA. The researchers performed frenectomy treatments on the children without knowing which group they belonged to (placebo or HA). Another researcher, other than the surgeon, performed control and postoperative measurements for each patient.
All the patients underwent dental treatment and initial periodontal therapy and followed the oral hygiene instructions. Before the labial frenectomy procedure, 10% lidocaine was topically applied to all the patients to reduce the pain before administering local anesthesia (Avixa İlaç San. Tic Ltd. Şti., Başakşehir, İstanbul, Turkey). Local infiltration anesthesia with 4% articaine, including epinephrine (epinephrine:articaine, 1:100,000), was applied to the vestibular oral mucosa and right and left regions of the frenulum (Ultracaine D-S Fort Ampul, Avixa İlaç San. Başakşehir, İstanbul, Turkey). The usage protocol for the diode laser was initiated after a waiting time of around 10 min.
The diode laser used in this study was the BIOLASE Epic10™ (BIOLASE INC., CA, USA). The laser interface was set to the “Frenectomy” mode. The features of the frenectomy mode are shown in Table 1. Frenectomy was performed using a 940-nm indium gallium arsenide phosphide (InGaAsP) semiconductor diode laser. The laser was operated in pulseCP2 wave mode at a power of 1.0 watt (W), and a 400-μm diameter optical fiber tip was used (Fig. 2). After the patient and operator wore protective glasses, the environmental safety measures were taken before carrying out the frenectomy procedure following the guidelines in Table 2.Fig. 2

The frenectomy procedure stages utilizing the diode laser. a The Epic 10 diode laser. b Surgical procedure of the diode laser assisted-frenectomy. c The application of 0.6% HA gel as a demonstration for parents

Table 2

Parameters for the 940-nm diode laser

BIOLASE Epic 10™ diode soft tissue laser
Intrinsic parameters
Laser classification	IV
Medium	InGaAs semiconductor diode
Wavelength	940 ± 10 nm
Max power output	10 W
Power accuracy	± 20%
Power modes	Continuous, pulse modulation
Delivery system	The flexible optic fiber
Energy distribution	Quasi-flattop
Energy delivery	Non-initiated
Fiber tips diameter	200, 300, and 400 μm
Pulse duration	0.01–20 ms
Pulse interval	0.04–20 ms
Pulse repetition rate	Up to 20 kHz
Spot size (for surgical handpiece)	400 μm (maximum in contact mode)
Nominal ocular hazard distance	2.71 m
Maximum permissible exposure	30 W/m2
Beam divergence	7–22° per side angle
Aiming beam	Max. 1 mW, 625–670 nm, class 2
Standard fiber cable length	5 feet (1.5 m)
Adjustable parameters
Frenectomy operating mode	Pulse mode
Used power	1.0 W
Irradiation mode	The activation occurs once the pedal is pressed and the targeted tissue is contacted.
Used optic fiber tip diameter	400 μm/7
Pulse duration	1 ms
Pulse interval	1 ms
Peak power	2.0 W
Average power	1.0 W
Beam divergence	8° per side
Speed of movement	2 mm/sec
Calculated parameters
Total energy	60 J
Power density	⁓ 796 W/cm2
Average power density	100 W/cm2
Peak power density	200 W/cm2
Spot area at tissue	0.00126 cm2
Spot diameter at tissue	⁓ 0.04 cm
Tip area	0.005024 cm2
% on time	50%
Energy density	⁓ 1500 J/cm2

Using brushing movements, the laser was applied to the upper and lower parts of the frenulum near the hemostat. Moreover, the remaining muscular attachments of the periosteum were removed to eliminate the periosteal adhesion. The remaining ablated tissue was cleared using a moistened gauze with a sterile saline solution [2 (link), 13 (link)]. The average time taken for the procedure with the diode laser was 60 s. After the surgical procedure, the participants were instructed on how to apply the HA gel. The patients in the 0.6% HA group were given seven blister disposable packages containing 0.6% HA (Aftamed Shield Gel, Aktident, Üsküdar, İstanbul, TURKEY). The participants in the HA group were instructed to apply HA Gel to the wound area thrice a day for 1 min after opening a new blister pack and refrain from eating or drinking for 10–15 min [4 (link)] (Fig. 2).
In conventional techniques, the upper lip is extended, and a straight hemostat is attached to the frenulum into the depth of the vestibular fold. Triangular-shaped incisions were made above and below the hemostat using a no. 15 scalpel (HM0240, Beybi, Ümraniye, İstanbul, Turkey) until the labial frenulum was released from the soft tissue. Muscle fiber dissection was performed on the submucosa of the lateral walls after excision of the frenulum with curved forceps to detach them from the periosteum. A 4/0 silk suture was used for primary wound closure (DOGSAN, Beşiktaş, İstanbul, Turkey). After surgical frenectomy was performed, the patients and their parents were advised to be cautious and avoid the exposure to mechanical trauma, flossing, and chewing movements. Gentle tooth brushing was permitted using a surgical toothbrush (Surgical Mega Soft, Curaprox, Kriens, Switzerland). The interrupted sutures were removed 1 week after surgery [1 (link), 2 (link), 13 (link)] (Fig. 3).Fig. 3

The application of 0.6% HA gel as a demonstration for parents after carrying out the classic frenectomy procedure

The Silness–Löe plaque index (PI), gingival index (GI), pocket depth (PD), bleeding on probing (BOP), keratinized gingival width (KGW), attached gingival width (AGW), and attached gingival thickness (AGT) were measured using a Williams periodontal sond (122-006, HuFriedy, Chic, IL, USA). They were recorded prior to the labial frenectomy operations and at 1 and 3 months after the operations [2 (link), 13 (link)].
The VAS was used to evaluate the pain and discomfort levels of the patients, with scores between 0 and 10, where the score of “0” indicated no pain and discomfort and the score of “10” indicated severe pain and discomfort. The participants were requested to complete the questionnaire once daily for 1 week following the operation [2 (link), 4 (link), 13 (link), 20 (link)].
Statistical analyses were performed using SPSS for Windows software package (version 20.0). For descriptive statistics, the mean ± standard deviation and median (minimum–maximum) were used for the quantitative variables, while the number of patients (percentage) was used for the qualitative variables. To determine whether there was a difference between the two categories of the qualitative and quantitative variables, Mann-Whitney U test was used as the normal distribution hypothesis was not provided. Repeated-measures analysis of variance (ANOVA) and two-way repeated-measures analysis of variance were used to examine the change in variables with repeated measures over time and between groups. A significance level of 0.05 was set for statistical analyses.