Soft Tissue Wound Healing Following Different Gingivectomy Techniques

Gingival Overgrowth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435068
• Other study ID #: 2015-KAEK-86/05-39
• Status: Completed
• Phase: N/A
• First received: February 4, 2018
• Last updated: February 9, 2018
• Start date: April 1, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: February 2018
• Source: T.C. Dumlupinar Üniversitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Overgrowth

Intervention

Device:
• Ceramic rotary bur
Gingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur
• Diode laser
The fiber optic laser tip had a 320-µm diameter with a 2.8 W output power were used in the study.
• Scalpel
Scalpel surgery were performed as control group (conventioanl group).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
T.C. Dumlupinar Üniversitesi

References & Publications (3)

Favia G, Tempesta A, Limongelli L, Suppressa P, Sabbà 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. — View 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. — View Citation

Tomasi C, Schander K, Dahlén G, Wennström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative wound healing change	After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization	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	Postoperative pain	The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms	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
Secondary	Postoperative erythema	The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms	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
Secondary	Postoperative burning	The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms	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