Temperature and Healing in Treatment of Gingival Enlargement

NCT04016064 | Completed DMC

• 1 other identifier: OMU KAEK 2012/167
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Enlargement

Keywords

gingival enlargement, Er:YAG, Nd:YAG, electrosurgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gingival temperature

  The gingival temperature was measured during surgical procedures

Study Arms (3)

group 1;

OTHER

Er:YAG laser

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

group 2

OTHER

Nd:YAG laser

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

group 3

OTHER

Electrosurgery

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

Interventions

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

1. 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. 2. 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. 3. Electrosurgical (Servotome Classic System, High Frequency Surgical Equipment, Satelec, France). 4. Conventional surgical method was applied with hand instruments and gingivectomy knives.

group 1;; group 2; group 3

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 in anterior quadrants.

You may not qualify if:

• pregnancy/lactation
• drug use, previous periodontal therapy within 6 months
• previous antibiotic use within 6 months, smoking
• the existence of attachment/bone loss. .

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Hyperplasia; Hyperthermia

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)