Scalpel Versus Laser Gingivectomy in Orthodontic Patients in the Management of Periodontal Health
Condition: Orthodontic Appliance Complication; Gingival Overgrowth
MeSH terms: Gingival Overgrowth
Study type: Interventional

Summary: 
      Patients undergoing orthodontic treatment with fixed appliances usually develop gingival
      enlargement (GE). Its development is usually attribute to chronic inflammation, and may cause
      both esthetic and functional problems for the patient. In many cases, the gingival
      hyperplasia demands periodontal surgery in order to increase the length of the crown during
      or after the orthodontic treatment. Previously conventional surgical procedures were
      performed using a scalpel under local anaesthesia for these procedures. Lately the use of
      laser has been proposed. The majority of the studies comparing laser gingivectomy with
      scalpel gingivectomy show some limits: they are not randomized, they are not prospective, and
      they have no control group. The primary objective of the present investigation was to conduct
      a randomized controlled trial (RCT) evaluating the effectiveness of diode laser gingivectomy
      versus scalpel gingivectomy in the management of periodontal health among patients receiving
      fixed orthodontic appliance therapy, compared with a non surgical control group.
    

Detailed description: 
      Gingival enlargement (GE) is one of the most common soft tissue problems in patients
      undergoing orthodontic fixed treatment, particularly when spaces are rapidly closed and oral
      hygiene is poor. The mechanism by which GE occurs during orthodontic treatment is not fully
      understood. The initiation and development of periodontal disease depend on a dynamic
      equilibrium between the microbial challenge and the host's immune-inflammatory responses. The
      presence of fixed appliances influences plaque accumulation around the retentive components
      attached to the teeth and the colonization of important periodontopathic bacteria. Chronic
      inflammation of the soft tissues is caused by a significant increase in edema and
      inflammatory cells that can influence the sub-gingival ecosystem by creating an appropriate
      anaerobic environment, leading to a shift in the composition of the microflora. When gingival
      tissues are enlarged, varying from mild enlargement of isolated interdental papillae to
      segmental or uniform and marked enlargement affecting one or both jaws, the tooth surfaces
      become difficult to access, inhibiting good oral hygiene and resulting in more inflammation
      and bleeding because enlarged gingival tissues. In artificially deeper periodontal pockets,
      the root surfaces are contaminated with an accumulation of plaque and calculus, as well as
      infiltration of bacteria and bacterial endotoxins into cementum. Complete removal of these
      harmful substances is essential for the healing of periodontal tissue. However, nonsurgical
      periodontal treatment (including oral hygiene instruction, scaling, root planing, and
      prophylaxis) is not always effective when GE is extensive and self-care is compromised. When
      GE further impedes the maintenance of oral hygiene (thereby resulting in further damage to
      periodontal tissues), causes aesthetic and functional problems, and compromises orthodontic
      tooth movement, it is necessary to provide additional surgery treatment such as gingivectomy,
      in order to correct gingival border contours. Gingivectomy can be performed by conventional
      scalpels, electrosurgery, chemosurgery, and laser. Preservation of biologic width is the
      therapeutic endpoint of all these procedures. 3 mm of tooth structure above the osseous crest
      is considered safe to prevent any attachment loss. The conventional surgery performed by a
      small scalpel has been considered the most common method because of its ease of use,
      accuracy, and minimal damage to tissues. However, scalpels do not provide a good hemostasis,
      which is important on highly perfused tissues such as in the oral cavity. The advent of diode
      lasers highly absorbable by melanin and hemoglobin allows soft-tissue manipulations providing
      sound results in periodontal surgery, tissue alterations related to orthodontic treatment,
      and oral lesions. The diode laser separates and coagulates at the same time, facilitating
      immediate hemostasis and resulting in minimal bleeding. Healing is rapid and there is reduced
      potential for infection. The diode laser has an affinity for only soft tissue, thereby
      preventing damage to the surrounding bone and enamel. Therefore, using diode lasers might be
      advantageous because of better control, potentially lower pain and inflammation, and improved
      wound healing. In literature, no studies directly compared conventional scalpel surgery
      versus diode laser-assisted surgery in orthodontic patients with GE. Moreover, the majority
      of the studies comparing laser gingivectomy with scalpel gingivectomy show some limits: they
      are not randomized, they are not prospective, and they have no control group. Therefore, the
      aim of the present study was to compare the use of the 810nm diode laser with conventional
      surgery and to evaluate the effectiveness of gingivectomy as an adjunct to nonsurgical
      periodontal treatment in the management of GE during orthodontic treatment. The Consolidated
      Standards of Reporting Trials (CONSORT) checklist was used as a guideline for conducting and
      reporting this trial. The present Randomized Clinical Trial was designed as a prospective
      three-arm parallel group randomized clinical trial with 1:1:1 allocation ratio. The study was
      approved by the Ethics Committee at the University of Rome "Tor Vergata", (protocol number
      206/17), and informed consent was obtained from the patients' parents. A total of 60 (33
      Males; 27 Females) subjects, with a mean age of 14.4 ± 1.9 years (range 11.7-19.8 years),
      undergoing orthodontic treatment at the Department of Orthodontic of the University of Rome
      "Tor Vergata" were recruited for the study. Gingival overgrowth diagnosis was defined as
      presence of quadratic anterior teeth (crown width/length ratio ≤0.85), gingival margin
      located incisal to the tooth cervical convexity and presence of mean Probing Pocket Depths
      (PPD) ≥ 4mm coronal to the cement-enamel junction (CEJ) at three buccal points around each
      tooth of the anterior segment (mesial, mid-point, distal). Crown Width (CW) and Clinical
      Crown Length (CCL) were measured pre-operatively with a digital caliper: CCL, measured as the
      distance between incisal edge and gingival margin along the tooth long axis; CW measured at
      the point between incisal and middle third of CCL. All subjects received ongoing nonsurgical
      periodontal treatment and instructions on oral hygiene. After the conventional management
      approach for gingival enlargement, patients with persistent gingival overgrowth were enrolled
      in the study and blindly assigned to three groups. In the first group (TG1), all subjects
      underwent a conventional scalpel gingivectomy of the maxillary anterior sextant. In the
      second group (TG2), all subjects were treated using laser-assisted gingivectomy; while
      subjects assigned to the third group underwent only nonsurgical periodontal treatment and
      served as the control group (CG). Both TGs were consecutively treated by one clinician. The
      PPDs were recorded to determine the biologic width and to assess how much tissue could be
      contoured without involving osseous surgery, using a North Carolina periodontal probe.
      Remembering that there exists a 3.0 mm biologic zone, the maximum amount of tissue removal
      could be calculated. The periodontal probe was placed apically to the alveolar crest, and the
      marginal gingival level was measured. An explorer was used to mark reference spots of the
      biologic zone, serving as the visual finishing point. At baseline (before surgery) all
      patients of the three groups underwent a full periodontal screening. Their oral hygiene and
      gingival inflammation were assessed using CCL, PPD, Plaque Index (PI) and Gingival Index (GI)
      at three buccal points around each tooth of the anterior segment (mesial, mid-point, distal).
      All measures were repeated at 1, 3 and 6 months post-surgery or nonsurgical periodontal
      treatment. Overall patient data were calculated as mean value by averaging measurements in
      all sites of six upper anterior teeth. A sample size for this trial was calculated according
      to the method proposed by Whitehead et al. For a standardized effect size of 1 (a clinically
      relevant change of 0.75 mm with a combined SD of 0.68 mm derived from Mavroggianis et al.)
      for the primary outcome variable PPD at 3 months, a sample size of 17 subjects per group was
      required for a type I error rate of 5% and a power of 80%. To account for potential dropouts,
      20 subjects per group were recruited. Allocation of patients to the three groups was
      determined by a computer-generated randomization list using Rv.0.1 software and by a block
      size of 4. Then, the allocation information (randomization results) was concealed in opaque
      and sealed envelopes by the statistician. The observer who performed all the measurements was
      blinded to the group assignment. The study was blinded in regard to the statistical analysis:
      blinding was obtained by eliminating from the elaboration file every reference to patient
      group assignment. Reliability of the periodontal assessments was conducted among 10 patients
      throughout the study. Exploratory statistics revealed that all periodontal variables were
      normally distributed (Kolmogorov-Smirnov test) with equality of variances (Levene's test).
      All statistical computations were performed with SPSS software (Statistical Package for the
      Social Sciences, SPSS, Version 12, Chicago, IL, USA).
    

Intervention name(s): Scalpel Gingivectomy; Laser Gingivectomy; Nonsurgical periodontal treatment
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The patients were anesthetized in the area around the teeth which were to undergo the procedure with local anesthesia (Drug: 2% lidocaine and 1:80,000 adrenaline). Initially, the Periodontal Probing Depth was measured and when sufficient anesthesia was achieved, biologic width calculation was done by the trans-gingival probing method. Once the amount of gingival tissue to be excised was demarcated, an external bevel incision was performed by using a scalpel blade (Device: scalpel blade No.15) and the gingival tissue was excised. Left out tissue tags and any beads of granulations tissue were removed to attain a smooth surface.; In the Laser Gingivectomy group, the procedure was performed by using a 810 nm diode laser (Device: 810 nm FOX III diode laser) . Though a local anesthetic gel is sufficient considering that the procedure is minimally invasive, the area was adequately anesthetized with 2% lidocaine and 1:80,000 adrenaline. The laser unit, comprising of a 300 μm disposable tip, was used in a contact mode with a setting of 1 to 1.5 watts in continuous mode along the demarcated area with a paint brush like strokes progressing slowly to remove the gingival tissue and expose adequate amount of tooth structure. High-volume suction was used to evacuate the laser plume and charred odor; In all subjects of the Control Group a full-mouth periodontal debridement was performed at baseline, 1 and 3 months with an ultrasonic scaler. Chlorhexidine prophylaxis (0.05% chlorhexidine gluconate) was also administered twice a day for 2 weeks after the periodontal treatment. Oral-hygiene instructions were reinforced again.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a prospective three-arm parallel group randomized clinical trial with 1:1:1 allocation ratio
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingival overgrowth; diode laser gingivectomy; scalpel gingivectomy; orthodontic treatment