Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques
Primary Purpose
Gingival Enlargement
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Resective Gingival Surgery
Sponsored by
About this trial
This is an interventional screening trial for Gingival Enlargement
Eligibility Criteria
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
Sites / Locations
- Tokat Gaziosmanpasa University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Group A
Group B
Group C
Group D
Arm Description
Conventional Gingivectomy:Technique is performed with conventional surgical instruments.
Diode Laser Assisted Gingivectomy: Technique is performed with using diode laser.
Er:YAG Laser Assisted Gingivectomy: Technique is performed with using Er:YAG laser.
Negative Control Group
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04304391
First Posted
March 6, 2020
Last Updated
March 10, 2020
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT04304391
Brief Title
Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Enlargement
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Conventional Gingivectomy:Technique is performed with conventional surgical instruments.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Diode Laser Assisted Gingivectomy: Technique is performed with using diode laser.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Er:YAG Laser Assisted Gingivectomy: Technique is performed with using Er:YAG laser.
Arm Title
Group D
Arm Type
No Intervention
Arm Description
Negative Control Group
Intervention Type
Procedure
Intervention Name(s)
Resective Gingival Surgery
Intervention Description
Gingivectomy and gingivoplasty:Resective gingival surgical procedured
Primary Outcome Measure Information:
Title
Evaluation of Gingival Temperature
Description
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.
Time Frame
6 months
Title
Evaluation of Gingival Epithelization
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluation of Gingival Pain Levels: Visual Analog Scale
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Tokat Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques
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