Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques

Gingival Enlargement Clinical Trial

Official title:

The Determination of the Operative Temperature Levels Using Er:YAG Laser and Diode Laser Supported Resective Gingival Surgery and the Clinical and Biochemical Evaluation of it's Effect on Postoperative Imflammation, Epithelization and Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04304391
• Other study ID #: TOGUGKARA
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: March 2020
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: The aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including Er:YAG laser, diod laser, and conventional techniques.

Method: This study was conducted on 32 female, 13 male, a total of 45 individuals (study group patients) with an indication of resective gingival surgery in the anterior region of the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative control group patients) with a healthy gingiva. Clinical periodontal parameters, gingival crevicular fluid (GCF) KGF-2 and VEGF-A levels and gingival temperature levels were recorded before the investigation and during operations with 3 different techniques, gingival temperature was measured. Gingival temperature and epithelization levels in 3, 7, 14 and 21 days; GCF KGF-2 and VEGF-A levels in 14 and 21 days and pain levels between 1-7 days of post-operative healing process were evaluated. Preoperative anxiety and postoperative satisfaction were evaluated through questionnaires

Description:

Objective: The aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including Er:YAG laser, diod laser, and conventional techniques commonly used in resective gingival surgeries in terms of preoperative anxiety, postoperative satisfaction, epithelization, gingival temperature, inflammation and pain levels in post-operative healing process.

Method: This study was conducted on 32 female, 13 male, a total of 45 individuals (study group patients) with an indication of resective gingival surgery in the anterior region of the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative control group patients) with a healthy gingiva. Clinical periodontal parameters, gingival crevicular fluid (GCF) KGF-2 and VEGF-A levels and gingival temperature levels were recorded before the investigation and during operations with 3 different techniques, gingival temperature was measured. Gingival temperature and epithelization levels in 3, 7, 14 and 21 days; GCF KGF-2 and VEGF-A levels in 14 and 21 days and pain levels between 1-7 days of post-operative healing process were evaluated. Preoperative anxiety and postoperative satisfaction were evaluated through questionnaires

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 15, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• systemically healthy individuals

• the existence of at least 20 functioning teeth,

• the existence of chronic inflammatory gingival enlargement

Exclusion Criteria:

• pregnancy/lactation,

• drug use,

• previous periodontal therapy within 6 months

Related Conditions & MeSH terms

• Gingival Enlargement
• Gingival Hyperplasia
• Gingival Hypertrophy
• Gingival Overgrowth

Intervention

Procedure:
• Resective Gingival Surgery
Gingivectomy and gingivoplasty:Resective gingival surgical procedured

Locations

Country	Name	City	State
Turkey	Tokat Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Gingival Temperature	Operative and post operative gingival temperature levels of the application region measured and recorded with using a noncontact infrared thermometer. The temperature measurement during the process was performed by an infrared thermometer (Optris GMBH, Manuel LS, Berlin, Germany). The device had a measurement and recording range from -35 ° C to 900 ° C, optical resolution 75: 1, thermal resolution 0.1 ° C, waveband range 8-14, USB interface and graphical software program.	6 months
Primary	Evaluation of Gingival Epithelization	Epithelization levels of resection region were measured and evaluated with using Image J software. Wound surface epithelization in the healing process was evaluated with a staining solution (Mira-2-tone, GMBH & Co., Duisburg, Germany). The treatment area was isolated. The solution carrier was applied with cotton pellets. The excess solution was removed by air-water spray. The standardized photographs were taken and transferred to the java based analysis program (Image J 1.31o, National Institutes of Health, Bethesda, MD, USA). The dark stained areas were calculated in the computer environment	6 months
Secondary	Evaluation of Gingival Pain Levels: Visual Analog Scale	Pain levels were evaluated with Visual Analog Scale in post operative process.A visual analogue scale (VAS) was used to evaluate pain after surgeries. Patients were asked to mark the pain levels at the levels from 0 (no pain) to 10 (the most severe pain) on the scale	6 months