Temperature and Healing in Treatment of Gingival Enlargement

Gingival Enlargement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016064
• Other study ID #: OMU KAEK 2012/167
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: December 1, 2013

Study information

• Verified date: July 2019
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2013
• Est. primary completion date: May 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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. .

Related Conditions & MeSH terms

• Gingival Enlargement
• Gingival Hyperplasia
• Gingival Hypertrophy
• Gingival Overgrowth
• Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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