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Soft Tissue Wound Healing Following Different Gingivectomy Techniques

Primary Purpose

Gingival Overgrowth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ceramic rotary bur
Diode laser
Scalpel
Sponsored by
T.C. Dumlupınar Üniversitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Overgrowth focused on measuring rotary, diode laser, gingivectomy, wound healing

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The criteria for inclusion in the study were as follows:

  • systemically healthy individuals
  • nonsmokers
  • horizontal and vertical gingival overgrowth indexes with a "score 1" or "score 2"
  • mean bleeding on probing and mean plaque index value < 20% (indicating good oral hygiene)
  • no clinical attachment loss and
  • a minimum of four teeth at each surgical site.

Exclusion Criteria:

The exclusion criteria were as follows:

  • systemic disease that could influence the outcome of the treatment, -pregnancy and/or lactation,
  • allergy,
  • conditions requiring antibiotic prophylaxis and anti-inflammatory medications, -acute or untreated periodontitis
  • the use of an analgesic before the surgical procedure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Ceramic rotary bur

    Diode laser

    Scalpel

    Arm Description

    For the ceramic bur group(Meisenger gingivectomies, ceramic rotary burs were used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.

    In the laser group (LG), a diode laser was applied to the operation sites in accordance with the manufacturer's guidelines (2.8 W continuous wave mode, wavelength 980 nm). The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power. The laser never made contact with the gingival tissue. The practice distance did not affect the laser spot size, which was 0.5 cm-1 cm. Smoke associated with the laser application was aspirated from the surgical site.

    In the scalpel group following the local anesthetic administration, the gingivectomy was performed with a #15 scalpel. Subsequent to the operation, the borderline of gingiva was determined via the use of a pointer dental tweezers, and excessive gingival tissue was then removed with Gracey curettes

    Outcomes

    Primary Outcome Measures

    Postoperative wound healing change
    After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization

    Secondary Outcome Measures

    Postoperative pain
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms
    Postoperative erythema
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms
    Postoperative burning
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms

    Full Information

    First Posted
    February 4, 2018
    Last Updated
    February 9, 2018
    Sponsor
    T.C. Dumlupınar Üniversitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03435068
    Brief Title
    Soft Tissue Wound Healing Following Different Gingivectomy Techniques
    Official Title
    The Evaluation of Soft Tissue Wound Healing Following Different Gingivectomy Applications: A Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    September 30, 2017 (Actual)
    Study Completion Date
    November 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    T.C. Dumlupınar Üniversitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to evaluate the degree of clinical discomfort and the issues experienced by patients and to use a software image program to compare wound healing during the 2-week period following gingivectomy performed with different techniques.
    Detailed Description
    Horizontal and vertical gingival overgrowth indexes were evaluated before and after surgery during each follow-up controls. The vertical distance of gingival tissue was measured from the gingival margin to the cement-enamel junction (gingival overgrowth [GO] index). Horizontal gingival values were also recorded between the tooth surfaces and the papillary tissue surface at the interdental contact point as buccolingual aspect (mesiobuccal [MB] index). Postoperative Evaluations The postoperative parameters, including pain, burning, edema, vascularization, erythema, epithelization, bleeding and carbonization, were recorded at 1, 3, 5, 7, and 14 days postoperatively. Postoperative pain, burning, erythema, vascularization, and edema were assessed via the visual analogue scale (VAS). The VAS is a 100-mm horizontal-line scale that is used to quantify subjective symptoms such as pain, burning, erythema, vascularization, and edema. In the present study, researchers used a standard VAS on which patients drew a vertical sign along a 10-cm scale from 0 (no pain) to 10 (highest degree of pain). Bleeding and carbonization during the postoperative period were assessed as either present or absent. Patients evaluated their postoperative pain, burning, and bleeding values. The same researcher evaluated erythema, vascularization, edema, and epithelization values. Evaluation of Surgical Wound Area After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization. A blinded researcher who used a standard digital camera to take standard magnification photographs assessed the operation area, consisting of the epithelium. The researcher examined all photographs with the assistance of an image-analyzing software program. The mesio-distal width of the maxillary right central tooth was recorded for each patient, and photographs were calibrated via the reference values. In the areas subjected to hydrogen peroxide application and experiencing tissue reaction, there was a lack of an epithelial layer in the wound area. The wound surface areas of foamy fields on the all of the groups' photographs were recorded on days 1, 3, 5, 7, and 14 following the gingivectomies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Overgrowth
    Keywords
    rotary, diode laser, gingivectomy, wound healing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The trial is parallel-designed, controlled, prospective clinical study.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ceramic rotary bur
    Arm Type
    Experimental
    Arm Description
    For the ceramic bur group(Meisenger gingivectomies, ceramic rotary burs were used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.
    Arm Title
    Diode laser
    Arm Type
    Experimental
    Arm Description
    In the laser group (LG), a diode laser was applied to the operation sites in accordance with the manufacturer's guidelines (2.8 W continuous wave mode, wavelength 980 nm). The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power. The laser never made contact with the gingival tissue. The practice distance did not affect the laser spot size, which was 0.5 cm-1 cm. Smoke associated with the laser application was aspirated from the surgical site.
    Arm Title
    Scalpel
    Arm Type
    Active Comparator
    Arm Description
    In the scalpel group following the local anesthetic administration, the gingivectomy was performed with a #15 scalpel. Subsequent to the operation, the borderline of gingiva was determined via the use of a pointer dental tweezers, and excessive gingival tissue was then removed with Gracey curettes
    Intervention Type
    Device
    Intervention Name(s)
    Ceramic rotary bur
    Other Intervention Name(s)
    Meisenger ceramic rotary bur
    Intervention Description
    Gingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur
    Intervention Type
    Device
    Intervention Name(s)
    Diode laser
    Other Intervention Name(s)
    SiroLase Advance &Xtend
    Intervention Description
    The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power were used in the study.
    Intervention Type
    Device
    Intervention Name(s)
    Scalpel
    Intervention Description
    Scalpel surgery were performed as control group (conventioanl group).
    Primary Outcome Measure Information:
    Title
    Postoperative wound healing change
    Description
    After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization
    Time Frame
    The wound surface areas of foamy fields on the all of the groups' photographs were recorded change between 1st day and 14th day following the gingivectomies.
    Secondary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms
    Time Frame
    Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies
    Title
    Postoperative erythema
    Description
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms
    Time Frame
    Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies
    Title
    Postoperative burning
    Description
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms
    Time Frame
    Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The criteria for inclusion in the study were as follows: systemically healthy individuals nonsmokers horizontal and vertical gingival overgrowth indexes with a "score 1" or "score 2" mean bleeding on probing and mean plaque index value < 20% (indicating good oral hygiene) no clinical attachment loss and a minimum of four teeth at each surgical site. Exclusion Criteria: The exclusion criteria were as follows: systemic disease that could influence the outcome of the treatment, -pregnancy and/or lactation, allergy, conditions requiring antibiotic prophylaxis and anti-inflammatory medications, -acute or untreated periodontitis the use of an analgesic before the surgical procedure.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahu Uraz, PhD Dr
    Organizational Affiliation
    Gazi University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19485829
    Citation
    Giannelli M, Bani D, Tani A, Pini A, Margheri M, Zecchi-Orlandini S, Tonelli P, Formigli L. In vitro evaluation of the effects of low-intensity Nd:YAG laser irradiation on the inflammatory reaction elicited by bacterial lipopolysaccharide adherent to titanium dental implants. J Periodontol. 2009 Jun;80(6):977-84. doi: 10.1902/jop.2009.080648.
    Results Reference
    background
    PubMed Identifier
    16579711
    Citation
    Tomasi C, Schander K, Dahlen G, Wennstrom JL. Short-term clinical and microbiologic effects of pocket debridement with an Er:YAG laser during periodontal maintenance. J Periodontol. 2006 Jan;77(1):111-8. doi: 10.1902/jop.2006.77.1.111.
    Results Reference
    background
    PubMed Identifier
    26360009
    Citation
    Favia G, Tempesta A, Limongelli L, Suppressa P, Sabba C, Maiorano E. Diode laser treatment and clinical management of multiple oral lesions in patients with hereditary haemorrhagic telangiectasia. Br J Oral Maxillofac Surg. 2016 May;54(4):379-83. doi: 10.1016/j.bjoms.2015.08.260. Epub 2015 Sep 8.
    Results Reference
    background

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    Soft Tissue Wound Healing Following Different Gingivectomy Techniques

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