- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514316
Scalpel Versus Laser Gingivectomy in Orthodontic Patients in the Management of Periodontal Health
Scalpel Versus Laser Gingivectomy in the Management of Periodontal Health During Orthodontic Treatment: a Randomized Controlled Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Roma, Italy, 00133
- Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata".
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- overgrown gingivae on the labial side of the anterior teeth secondary to fixed appliance therapy,
- six maxillary anterior teeth present,
- healthy nonsmokers patients.
Exclusion Criteria:
- patients with poor oral hygiene;
- patients with mucogingival infection;
- patients taking medications that may cause drug-associated gingival enlargement (eg. calcium channel blockers, anticonvulsants, or immunosuppressants)
- patients currently pregnant or lactating;
- patients with any medical condition affecting wound healing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Scalpel Gingivectomy
Patients treated with Scalpel Gingivectomy on the labial side of the anterior maxillary teeth
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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.
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Active Comparator: Laser Gingivectomy
Patients treated with Laser Gingivectomy on the labial side of the anterior maxillary teeth
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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
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Active Comparator: Nonsurgical periodontal treatment
Patients treated with a full-mouth periodontal debridement
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing Pocket Depth Changes after Scalpel Gingivectomy vs Laser Gingivectomy compared with a Control Group receiving non surgical periodontal treatment only at 3 time points respect to baseline.
Time Frame: 6 months
|
The primary outcome is the reduction of the Pocket Depth. The objective is to evaluate the change in the Pocket Depth induced by Scalpel Gingivectomy or Laser Gingivectomy, compared with a nonsurgical periodontal treatment group at 3 time points respect to baseline: 1 month, 3 months and 6 months. Probing Pocket Depths (PPDs) were recorded at baseline to determine the biologic width and to assess how much tissue could be contoured without involving osseous surgery, using a North Carolina periodontal probe; Scalpel Gingivectomy or Laser Gingivectomy were performed in the treated groups. In the non surgical periodontal treatment group, full-mouth periodontal debridement was performed at baseline, 1 and 3 months with an ultrasonic scaler. Overall patient data were calculated as mean value by averaging measurements in all sites of six upper anterior teeth. |
6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased Clinical Crown Length (CCL) after Scalpel Gingivectomy vs Laser Gingivectomy
Time Frame: 6 months
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The secondary outcome is the increase of the CCL, measured as the distance between incisal edge and gingival margin along the tooth long axis. The objective is to evaluate the change in the CCL induced by Scalpel Gingivectomy or Laser Gingivectomy, compared with a nonsurgical periodontal treatment group. All measures were repeated at 1, 3 and 6 months post-surgery or full-mouth periodontal debridement. Overall patient data were calculated as mean value by averaging measurements of six upper anterior teeth. |
6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea Noviello, Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy
Publications and helpful links
General Publications
- Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- To TN, Rabie AB, Wong RW, McGrath CP. The adjunct effectiveness of diode laser gingivectomy in maintaining periodontal health during orthodontic treatment. Angle Orthod. 2013 Jan;83(1):43-7. doi: 10.2319/012612-66.1. Epub 2012 May 16.
- Silva CO, Soumaille JM, Marson FC, Progiante PS, Tatakis DN. Aesthetic crown lengthening: periodontal and patient-centred outcomes. J Clin Periodontol. 2015 Dec;42(12):1126-34. doi: 10.1111/jcpe.12482. Epub 2015 Dec 23.
- Mavrogiannis M, Ellis JS, Seymour RA, Thomason JM. The efficacy of three different surgical techniques in the management of drug-induced gingival overgrowth. J Clin Periodontol. 2006 Sep;33(9):677-82. doi: 10.1111/j.1600-051X.2006.00968.x. Epub 2006 Jul 20.
- Farista S, Kalakonda B, Koppolu P, Baroudi K, Elkhatat E, Dhaifullah E. Comparing Laser and Scalpel for Soft Tissue Crown Lengthening: A Clinical Study. Glob J Health Sci. 2016 Oct 1;8(10):55795. doi: 10.5539/gjhs.v8n10p73.
- Volchansky A, Cleaton-Jones P. Clinical crown height (length)--a review of published measurements. J Clin Periodontol. 2001 Dec;28(12):1085-90. doi: 10.1034/j.1600-051x.2001.281201.x.
- Mavrogiannis M, Ellis JS, Thomason JM, Seymour RA. The management of drug-induced gingival overgrowth. J Clin Periodontol. 2006 Jun;33(6):434-9. doi: 10.1111/j.1600-051X.2006.00930.x.
- McGuire MK, Scheyer ET. Laser-assisted flapless crown lengthening: a case series. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):357-64.
- Ize-Iyamu IN, Saheeb BD, Edetanlen BE. Comparing the 810nm diode laser with conventional surgery in orthodontic soft tissue procedures. Ghana Med J. 2013 Sep;47(3):107-11.
- Gong Y, Lu J, Ding X. Clinical, microbiologic, and immunologic factors of orthodontic treatment-induced gingival enlargement. Am J Orthod Dentofacial Orthop. 2011 Jul;140(1):58-64. doi: 10.1016/j.ajodo.2010.02.033.
- Zanatta FB, Ardenghi TM, Antoniazzi RP, Pinto TM, Rosing CK. Association between gingivitis and anterior gingival enlargement in subjects undergoing fixed orthodontic treatment. Dental Press J Orthod. 2014 May-Jun;19(3):59-66. doi: 10.1590/2176-9451.19.3.059-066.oar.
- Lione R, Pavoni C, Noviello A, Clementini M, Danesi C, Cozza P. Conventional versus laser gingivectomy in the management of gingival enlargement during orthodontic treatment: a randomized controlled trial. Eur J Orthod. 2020 Jan 27;42(1):78-85. doi: 10.1093/ejo/cjz032.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 206/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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