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OpenTrials
Completed

NCT Number: NCT03435068

Soft Tissue Wound Healing Following Different Gingivectomy Techniques

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ceramic rotary bur

Device

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

Diode laser

Device

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

Scalpel

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

T.C. Dumlupınar Üniversitesi

Other

Registry information

Official study title

The Evaluation of Soft Tissue Wound Healing Following Different Gingivectomy Applications: A Prospective Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2018
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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