Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques

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

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

Study Overview

• Status: Completed
• Conditions: Gingival Enlargement
• Intervention / Treatment: Procedure: Resective Gingival Surgery

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey, 60100
    • Tokat Gaziosmanpasa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Conventional Gingivectomy:Technique is performed with conventional surgical instruments.	Procedure: Resective Gingival Surgery; Gingivectomy and gingivoplasty:Resective gingival surgical procedured
Experimental: Group B; Diode Laser Assisted Gingivectomy: Technique is performed with using diode laser.	Procedure: Resective Gingival Surgery; Gingivectomy and gingivoplasty:Resective gingival surgical procedured
Experimental: Group C; Er:YAG Laser Assisted Gingivectomy: Technique is performed with using Er:YAG laser.	Procedure: Resective Gingival Surgery; Gingivectomy and gingivoplasty:Resective gingival surgical procedured
No Intervention: Group D; Negative Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 15, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingival Hyperplasia; Gingival Hypertrophy; Gingival Overgrowth
• Other Study ID Numbers: TOGUGKARA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No