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NCT Number: NCT04016064

Temperature and Healing in Treatment of Gingival Enlargement

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.

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Key information

Conditions

Gingival Enlargement Body Temperature Changes Gingival Diseases Gingival Hyperplasia Gingival Overgrowth Heat Stress Disorders Hyperthermia Mouth Diseases Pathological Conditions, Signs and Symptoms Periodontal Diseases Signs and Symptoms Stomatognathic Diseases Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. .

Treatment and study plan

Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery

Procedure
  • 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 outcomes

  1. Epithelization

    Time frame: Epithelization was evaluated at postoperative 7th day

    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 outcomes

  1. Gingival temperature

    Time frame: The gingival temperature was measured during surgical procedures

    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.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2019
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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