Soft Tissue Wound Healing Following Different Gingivectomy Techniques

NCT03435068 | Completed

• 1 other identifier: 2015-KAEK-86/05-39
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Overgrowth

Keywords

rotary; diode laser; gingivectomy; wound healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative pain

  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

• Postoperative erythema

  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

• Postoperative burning

  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

Study Arms (3)

Ceramic rotary bur

EXPERIMENTAL

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

Diode laser

EXPERIMENTAL

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

Scalpel

ACTIVE COMPARATOR

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

Interventions

Ceramic rotary bur DEVICE

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

Also known as: Meisenger ceramic rotary bur

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.

Also known as: SiroLase Advance &Xtend

Diode laser

Scalpel DEVICE

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

Scalpel

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• T.C. Dumlupınar Üniversitesi: lead

Related Publications (3)

• 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.

  PMID: 19485829 BACKGROUND

• 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.

  PMID: 16579711 BACKGROUND

• 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.

  PMID: 26360009 BACKGROUND

MeSH Terms

Conditions

Gingival Overgrowth

Interventions

Lasers, Semiconductor; Laser Therapy

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ahu Uraz, PhD Dr

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist .Prof

Model Details: The trial is parallel-designed, controlled, prospective clinical study.

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 15, 2018
• Study Start: April 1, 2016
• Primary Completion: September 30, 2017
• Study Completion: November 30, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share