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Soft Tissue Wound Healing Following Different Gingivectomy Techniques

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ClinicalTrials.gov Identifier: NCT03435068
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Berceste Guler, T.C. Dumlupınar Üniversitesi

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
Gingival Overgrowth Device: Ceramic rotary bur Device: Diode laser Device: Scalpel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : April 1, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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).




Primary Outcome Measures :
  1. Postoperative wound healing change [ 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. ]
    After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization


Secondary Outcome Measures :
  1. Postoperative pain [ 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 ]
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms

  2. Postoperative erythema [ 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 ]
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms

  3. Postoperative burning [ 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 ]
    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms



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

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): NCT03435068


Sponsors and Collaborators
T.C. Dumlupınar Üniversitesi
Investigators
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Study Director: Ahu Uraz, PhD Dr Gazi University
Publications:
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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: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Berceste Guler, T.C. Dumlupınar Üniversitesi:
rotary
diode laser
gingivectomy
wound healing
Additional relevant MeSH terms:
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Gingival Overgrowth
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases