Department of Clinical Sciences and Translational Medicine, University of Rome 'Tor Vergata', Italy.
Department of Dentistry, UNSBC, Tirana, Albania.
Eur J Orthod. 2020 Jan 27;42(1):78-85. doi: 10.1093/ejo/cjz032.
To compare the use of diode laser with conventional surgery evaluating the effectiveness of gingivectomy as an adjunct to non-surgical periodontal treatment in the management of gingival enlargement (GE) during orthodontic treatment.
Prospective three-arm parallel group randomized clinical trial with 1:1:1 allocation ratio.
Sixty subjects (33 males and 27 females), with a mean age of 14.4 ± 1.9 years, were selected according to inclusion criteria: overgrown gingivae on the labial side of the anterior teeth secondary to fixed appliance therapy, six maxillary anterior teeth present, and healthy non-smokers patients. Patients were enrolled in the study and randomly assigned to three groups by a computer-generated randomization list and by a block size of 4. The allocation information was concealed in opaque and sealed envelopes by the statistician. In the first group, all subjects underwent a conventional scalpel gingivectomy of the maxillary anterior sextant. In the second group, all subjects were treated using laser-assisted gingivectomy; while subjects assigned to the third group underwent only non-surgical periodontal treatment and served as control group (CG). The observer who performed all the measurements was blinded to the group assignment. Blinding was obtained by eliminating from the elaboration file every reference to patient group assignment. Intergroup comparisons of changes in the periodontal parameters were conducted at 1, 3, and 6 months using ANOVA with repeated measures and Tukey's post hoc tests. The significance level was set at P <0.05.
After 1 month, the TGs showed a significant improvement of all periodontal parameters when compared with the CG. No statistically significant differences were observed between the two TGs. At the 3-month observation, a relapse occurred in the TGs, while the CG showed the greater improvement of soft tissue health. In the 6-month versus 3-month evaluation, no significant differences between the three groups were found for any periodontal measurements. In the long-term evaluation (6 months versus baseline), a significant greater reduction of pockets were found in the TGs when compared with the CG.
The adjunct use of both scalpel gingivectomy and laser gingivectomy was more effective in controlling gingival inflammation than non-surgical periodontal treatment alone at 1, 3 and 6 months. In the control group, greater improvement in the periodontal parameters were observed within 3 months, depending on a self-care approach for the management of GE.
This study was a short-term study (6-month follow-up).
ClinicalTrials.gov (registration number: NCT03514316).
比较二极管激光与传统手术在正畸治疗中辅助牙龈切除术治疗牙龈肥大（GE）的效果。
前瞻性三臂平行组随机临床试验，分配比例为 1:1:1。
根据纳入标准选择 60 名受试者（33 名男性和 27 名女性），平均年龄 14.4±1.9 岁：固定矫治器治疗后唇侧前牙过度生长的牙龈，有 6 颗上颌前牙，以及健康的不吸烟者。患者入组后，通过计算机生成的随机列表和 4 个块大小进行随机分组。统计学家将分配信息隐藏在不透明且密封的信封中。第一组所有患者行上颌前牙六区常规手术刀牙龈切除术。第二组所有患者行激光辅助牙龈切除术；第三组仅行非手术牙周治疗，作为对照组（CG）。所有测量均由一位观察者进行，观察者对分组情况不知情。通过从文件中消除每个患者分组的参考来实现盲法。使用重复测量方差分析和 Tukey 事后检验对各组间牙周参数的变化进行组间比较。显著性水平设为 P<0.05。
治疗 1 个月后，TG 组的所有牙周参数均明显改善，与 CG 组相比差异有统计学意义。两组 TG 之间无统计学差异。在 3 个月的观察中，TG 组出现复发，而 CG 组软组织健康状况改善更大。6 个月与 3 个月评估时，三组间任何牙周测量均无显著差异。在长期评估（6 个月与基线相比）时，TG 组的牙周袋深度减少显著大于 CG 组。
与单纯非手术牙周治疗相比，在 1、3 和 6 个月时，联合使用手术刀牙龈切除术和激光牙龈切除术辅助治疗更能有效控制牙龈炎症。在对照组中，由于采用自我护理方法来管理 GE，在 3 个月内观察到牙周参数有更大的改善。
本研究为短期研究（6 个月随访）。
ClinicalTrials.gov（注册号：NCT03514316）。
