Clinical trial NCT04304391: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Enlargement
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: Evaluation of Gingival Temperature
timeFrame: 6 months
measure: Evaluation of Gingival Epithelization
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of Gingival Pain Levels: Visual Analog Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
Study officials:
References: