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Completed

NCT Number: NCT04304391

Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques

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

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Key information

Conditions

Gingival Enlargement Gingival Diseases Gingival Hyperplasia Gingival Overgrowth Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resective Gingival Surgery

Procedure

Gingivectomy and gingivoplasty:Resective gingival surgical procedured

Primary outcomes

  1. Evaluation of Gingival Temperature

    Time frame: 6 months

    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.

  2. Evaluation of Gingival Epithelization

    Time frame: 6 months

    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

Secondary outcomes

  1. Evaluation of Gingival Pain Levels: Visual Analog Scale

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2020
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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