Scalpel Versus Laser Gingivectomy in Orthodontic Patients in the Management of Periodontal Health

NCT03514316 | Completed

• 1 other identifier: 206/17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Appliance Complication; Gingival Overgrowth

Keywords

gingival overgrowth; diode laser gingivectomy; scalpel gingivectomy; orthodontic treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (1)

• Increased Clinical Crown Length (CCL) after Scalpel Gingivectomy vs Laser Gingivectomy

  6 months

Study Arms (3)

Scalpel Gingivectomy

ACTIVE COMPARATOR

Patients treated with Scalpel Gingivectomy on the labial side of the anterior maxillary teeth

Procedure: Scalpel Gingivectomy

Laser Gingivectomy

ACTIVE COMPARATOR

Patients treated with Laser Gingivectomy on the labial side of the anterior maxillary teeth

Procedure: Laser Gingivectomy

Nonsurgical periodontal treatment

ACTIVE COMPARATOR

Patients treated with a full-mouth periodontal debridement

Procedure: Nonsurgical periodontal treatment

Interventions

Scalpel Gingivectomy PROCEDURE

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.

Scalpel Gingivectomy

Laser Gingivectomy PROCEDURE

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

Laser Gingivectomy

Nonsurgical periodontal treatment PROCEDURE

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.

Nonsurgical periodontal treatment

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• overgrown gingivae on the labial side of the anterior teeth secondary to fixed appliance therapy,
• six maxillary anterior teeth present,
• healthy nonsmokers patients.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata".

Roma, 00133, Italy

Location

Related Publications (12)

• 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.

  PMID: 22591260 BACKGROUND

• 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.

  PMID: 26613260 BACKGROUND

• 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.

  PMID: 16856895 BACKGROUND

• 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.

  PMID: 27302447 BACKGROUND

• 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.

  PMID: 11737504 BACKGROUND

• 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.

  PMID: 16677333 BACKGROUND

• McGuire MK, Scheyer ET. Laser-assisted flapless crown lengthening: a case series. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):357-64.

  PMID: 21837301 BACKGROUND

• 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.

  PMID: 24391225 BACKGROUND

• 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.

  PMID: 21724088 BACKGROUND

• 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.

  PMID: 25162567 BACKGROUND

• 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.

  PMID: 26092476 BACKGROUND

• 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.

  PMID: 31111882 DERIVED

MeSH Terms

Conditions

Gingival Overgrowth

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Noviello

  Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate Student, Department of Orthodontics, Department of Clinical Sciences and Translational Medicine

Model Details: a prospective three-arm parallel group randomized clinical trial with 1:1:1 allocation ratio

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 2, 2018
• Study Start: February 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

IT (1)