Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques

NCT04304391 | Completed DMC

• 1 other identifier: TOGUGKARA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Enlargement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Evaluation of Gingival Pain Levels: Visual Analog Scale

  6 months

Study Arms (4)

Group A

EXPERIMENTAL

Conventional Gingivectomy:Technique is performed with conventional surgical instruments.

Procedure: Resective Gingival Surgery

Group B

EXPERIMENTAL

Diode Laser Assisted Gingivectomy: Technique is performed with using diode laser.

Procedure: Resective Gingival Surgery

Group C

EXPERIMENTAL

Er:YAG Laser Assisted Gingivectomy: Technique is performed with using Er:YAG laser.

Procedure: Resective Gingival Surgery

Group D

NO INTERVENTION

Negative Control Group

Interventions

Resective Gingival Surgery PROCEDURE

Gingivectomy and gingivoplasty:Resective gingival surgical procedured

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• systemically healthy individuals
• the existence of at least 20 functioning teeth,
• the existence of chronic inflammatory gingival enlargement

You may not qualify if:

• pregnancy/lactation,
• drug use,
• previous periodontal therapy within 6 months

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Hyperplasia

Condition Hierarchy (Ancestors)

Gingival Overgrowth; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 11, 2020
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 15, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

TU (1)