Clinical trial NCT03435068: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Overgrowth
Keywords: rotary
diode laser
gingivectomy
wound healing
Lead sponsor: T.C. Dumlupınar Üniversitesi
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial is parallel-designed, controlled, prospective clinical study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative wound healing change
timeFrame: 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 outcomes:
measure: Postoperative pain
timeFrame: 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
measure: Postoperative erythema
timeFrame: 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
measure: Postoperative burning
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Ahu Uraz, PhD Dr
role: STUDY_DIRECTOR
References:
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