Soft Tissue Wound Healing Following Different Gingivectomy Techniques

NCT ID: NCT03435068

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2017-11-30

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.

Conditions

Gingival Overgrowth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ceramic rotary bur

Intervention Type: DEVICE

Gingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur

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.

Group Type: EXPERIMENTAL

Diode laser

Intervention Type: DEVICE

The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power were used in the study.

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

Group Type: ACTIVE_COMPARATOR

Scalpel

Intervention Type: DEVICE

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

Interventions

Ceramic rotary bur

Gingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur

Intervention Type: 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.

Intervention Type: DEVICE

Scalpel

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

Intervention Type: DEVICE

Other Intervention Names

Meisenger ceramic rotary bur; SiroLase Advance &Xtend

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

T.C. Dumlupınar Üniversitesi

OTHER

Sponsor Role: lead

Responsible Party

Berceste Guler

Assist .Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahu Uraz, PhD Dr

Role: STUDY_DIRECTOR

Gazi University

References

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.

Reference Type: BACKGROUND

PMID: 19485829 (View on PubMed)

Tomasi C, Schander K, Dahlen G, Wennstrom 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. doi: 10.1902/jop.2006.77.1.111.

Reference Type: BACKGROUND

PMID: 16579711 (View on PubMed)

Favia G, Tempesta A, Limongelli L, Suppressa P, Sabba 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.

Reference Type: BACKGROUND

PMID: 26360009 (View on PubMed)

Other Identifiers

2015-KAEK-86/05-39

Identifier Type: -

Identifier Source: org_study_id