Temperature and Healing in Treatment of Gingival Enlargement
Primary Purpose
Gingival Enlargement
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Gingival Enlargement focused on measuring gingival enlargement, Er:YAG, Nd:YAG, electrosurgery
Eligibility Criteria
Inclusion Criteria:
- systemically healthy individuals
- the existence of at least 20 functioning teeth, the existence of chronic inflammatory gingival enlargement in anterior quadrants.
Exclusion Criteria:
- pregnancy/lactation
- drug use, previous periodontal therapy within 6 months
- previous antibiotic use within 6 months, smoking
- the existence of attachment/bone loss. .
Sites / Locations
- Gaziosmanpasa University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
group 1;
group 2
group 3
Arm Description
Er:YAG laser
Nd:YAG laser
Electrosurgery
Outcomes
Primary Outcome Measures
Epithelization
Wound surface epithelization in the healing process was evaluated with a staining solution (Mira-2-tone, GMBH & Co., Duisburg, Germany). (O. Ozcelik et al., 2008)
Secondary Outcome Measures
Gingival temperature
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.
Full Information
NCT ID
NCT04016064
First Posted
July 8, 2019
Last Updated
July 10, 2019
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT04016064
Brief Title
Temperature and Healing in Treatment of Gingival Enlargement
Official Title
Evaluation of Temperature and Healing in Treatment of Gingival Enlargement Using Different Gingivectomy Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
May 1, 2013 (Actual)
Study Completion Date
December 1, 2013 (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
Aim: Gingival enlargement is a common clinical condition which requires surgical approaches to alleviating these enlargement areas. The aim of this study was to investigate epithelization, gingival temperature, inflammation and pain levels in post-operative healing process in 4 different gingivectomy techniques including Er:YAG laser, Nd:YAG laser, electrosurgery and conventional gingivectomy in treatment of chronic inflammatory gingival enlargements.
Material and Method: A split-mouth designed study was conducted on 37 systemically healthy patients consisting of 19 females and 18 males, who had gingival enlargement areas on the left and right of maxillary and mandibular anterior regions. Gingival crevicular fluid (GCF) samples were collected, clinical periodontal parameters and gingival temperature levels were recorded at baseline and in the postoperative period. The gingival temperature was measured during surgical procedures. Gingival temperature and epithelization levels in 3rd, 7th, 10th and 15th days; GCF levels in 15th, 30th, and 90th days and pain levels in 2nd and 8th hours and between 1st-7th days of post-operative healing process were evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Enlargement
Keywords
gingival enlargement, Er:YAG, Nd:YAG, electrosurgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The present study was designed as a controlled clinical study with a randomized design. The study protocol was approved by the local ethical committee of Clinical Studies of Ondokuz Mayis University. The study population consisted of 37 participants (19 women, age 23.10±2.78, 18 men age 21.11±2.63).
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1;
Arm Type
Other
Arm Description
Er:YAG laser
Arm Title
group 2
Arm Type
Other
Arm Description
Nd:YAG laser
Arm Title
group 3
Arm Type
Other
Arm Description
Electrosurgery
Intervention Type
Procedure
Intervention Name(s)
Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery
Intervention Description
Er: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) 200 mj, 10 Hz, 2 Watt and VLP (long pulse, 1000 μs); 1.3 mm diameter, 8 mm long cylindrical, a sapphire tip was used with air cooling and water irrigation.
Nd: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) was applied at 4 watts, 50 Hz, 300 μm microfiber tip and SP (short pulse: 180 μs) settings.
Electrosurgical (Servotome Classic System, High Frequency Surgical Equipment, Satelec, France).
Conventional surgical method was applied with hand instruments and gingivectomy knives.
Primary Outcome Measure Information:
Title
Epithelization
Description
Wound surface epithelization in the healing process was evaluated with a staining solution (Mira-2-tone, GMBH & Co., Duisburg, Germany). (O. Ozcelik et al., 2008)
Time Frame
Epithelization was evaluated at postoperative 7th day
Secondary Outcome Measure Information:
Title
Gingival temperature
Description
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
The gingival temperature was measured during surgical procedures
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 in anterior quadrants.
Exclusion Criteria:
pregnancy/lactation
drug use, previous periodontal therapy within 6 months
previous antibiotic use within 6 months, smoking
the existence of attachment/bone loss. .
Facility Information:
Facility Name
Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Temperature and Healing in Treatment of Gingival Enlargement
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