Soft Tissue Wound Healing Following Different Gingivectomy Techniques

Sponsor
T.C. Dumlupınar Üniversitesi (Other)
Overall Status
Completed
CT.gov ID
NCT03435068
Collaborator
(none)
45
3
20

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ceramic rotary bur
  • Device: Diode laser
  • Device: Scalpel
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The trial is parallel-designed, controlled, prospective clinical study.The trial is parallel-designed, controlled, prospective clinical study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Evaluation of Soft Tissue Wound Healing Following Different Gingivectomy Applications: A Prospective Randomized Clinical Trial
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Nov 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ceramic rotary bur

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.

Device: Ceramic rotary bur
Gingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur
Other Names:
  • Meisenger ceramic rotary bur
  • Experimental: Diode laser

    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.

    Device: Diode laser
    The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power were used in the study.
    Other Names:
  • SiroLase Advance &Xtend
  • Active Comparator: Scalpel

    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

    Device: Scalpel
    Scalpel surgery were performed as control group (conventioanl group).

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative wound healing change [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.]

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

    Secondary Outcome Measures

    1. Postoperative pain [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]

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

    2. Postoperative erythema [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]

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

    3. Postoperative burning [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]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • T.C. Dumlupınar Üniversitesi

    Investigators

    • Study Director: Ahu Uraz, PhD Dr, Gazi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Berceste Guler, Assist .Prof, T.C. Dumlupınar Üniversitesi
    ClinicalTrials.gov Identifier:
    NCT03435068
    Other Study ID Numbers:
    • 2015-KAEK-86/05-39
    First Posted:
    Feb 15, 2018
    Last Update Posted:
    Feb 15, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Berceste Guler, Assist .Prof, T.C. Dumlupınar Üniversitesi
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2018