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Temperature and Healing in Treatment of Gingival Enlargement

10. juli 2019 opdateret af: mehmet murat taskan, Tokat Gaziosmanpasa University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kalkun
      • Tokat, Kalkun, 60100
        • Gaziosmanpasa University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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. .

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: group 1;
Er:YAG laser
Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery
  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.
Andet: group 2
Nd:YAG laser
Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery
  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.
Andet: group 3
Electrosurgery
Procedure: Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery
  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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Epithelization
Tidsramme: 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)
Epithelization was evaluated at postoperative 7th day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gingival temperature
Tidsramme: 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.
The gingival temperature was measured during surgical procedures

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tokat Gaziosmanpasa University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2012

Primær færdiggørelse (Faktiske)

1. maj 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

8. juli 2019

Først indsendt, der opfyldte QC-kriterier

10. juli 2019

Først opslået (Faktiske)

11. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OMU KAEK 2012/167

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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