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

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ClinicalTrials.gov Identifier: NCT03514316
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea Noviello, University of Rome Tor Vergata

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.

Condition or disease Intervention/treatment Phase
Orthodontic Appliance Complication Gingival Overgrowth Procedure: Scalpel Gingivectomy Procedure: Laser Gingivectomy Procedure: Nonsurgical periodontal treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Scalpel Versus Laser Gingivectomy in the Management of Periodontal Health During Orthodontic Treatment: a Randomized Controlled Clinical Trial
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Active Comparator: Scalpel Gingivectomy
Patients treated with Scalpel Gingivectomy on the labial side of the anterior maxillary teeth
Procedure: Scalpel Gingivectomy
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.

Active Comparator: Laser Gingivectomy
Patients treated with Laser Gingivectomy on the labial side of the anterior maxillary teeth
Procedure: Laser Gingivectomy
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

Active Comparator: Nonsurgical periodontal treatment
Patients treated with a full-mouth periodontal debridement
Procedure: Nonsurgical periodontal treatment
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.




Primary Outcome Measures :
  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. [ 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.



Secondary Outcome Measures :
  1. Increased Clinical Crown Length (CCL) after Scalpel Gingivectomy vs Laser Gingivectomy [ Time Frame: 6 months ]

    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.




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Ages Eligible for Study:   11 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514316


Locations
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Italy
Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata".
Roma, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
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Principal Investigator: Andrea Noviello Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrea Noviello, Post graduate Student, Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT03514316     History of Changes
Other Study ID Numbers: 206/17
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Noviello, University of Rome Tor Vergata:
gingival overgrowth
diode laser gingivectomy
scalpel gingivectomy
orthodontic treatment
Additional relevant MeSH terms:
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Gingival Overgrowth
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases