Roberta Lione1,2, Chiara Pavoni1,2, Andrea Noviello1, Marco Clementini3, Carlotta Danesi1, Paola Cozza1,2. 1. Department of Clinical Sciences and Translational Medicine, University of Rome 'Tor Vergata', Italy. 2. Department of Dentistry, UNSBC, Tirana, Albania. 3. Department of Periodontology, Vita Salute San Raffaele University, Milan, Italy.
Abstract
OBJECTIVES: 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. TRIAL DESIGN: Prospective three-arm parallel group randomized clinical trial with 1:1:1 allocation ratio. METHODS: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. RESULTS: 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. CONCLUSIONS: 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. LIMITATIONS: This study was a short-term study (6-month follow-up). TRIAL REGISTRATION: ClinicalTrials.gov (registration number: NCT03514316).
RCT Entities:
OBJECTIVES: 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. TRIAL DESIGN: Prospective three-arm parallel group randomized clinical trial with 1:1:1 allocation ratio. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. LIMITATIONS: This study was a short-term study (6-month follow-up). TRIAL REGISTRATION: ClinicalTrials.gov (registration number: NCT03514316).