Temperature and Healing in Treatment of Gingival Enlargement

Evaluation of Temperature and Healing in Treatment of Gingival Enlargement Using Different Gingivectomy Techniques

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.

Study Overview

• Status: Completed
• Conditions: Gingival Enlargement
• Intervention / Treatment: Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey, 60100
    • Gaziosmanpasa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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. .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group 1; Er:YAG laser	Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery; 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.
Other: group 2; Nd:YAG laser	Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery; 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.
Other: group 3; Electrosurgery	Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Epithelization was evaluated at postoperative 7th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The gingival temperature was measured during surgical procedures

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: gingival enlargement, Er:YAG, Nd:YAG, electrosurgery
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Gingival Diseases; Hypertrophy; Gingival Hyperplasia; Gingival Hypertrophy; Gingival Overgrowth
• Other Study ID Numbers: OMU KAEK 2012/167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No