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Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft

6. september 2016 oppdatert av: Neda Moslemi, Tehran University of Medical Sciences

The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft: A Randomized Controlled Clinical Trial

The aim of this randomized split-mouth design clinical trial is to clinically evaluate the effectiveness of diode laser in the healing of donor site of palate in free gingival graft.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Free gingival graft is the most predictable and successful method for increasing the width of keratinized tissue around teeth/dental implants and vestibular deepening. However, patient discomfort during the healing time is a major disadvantage of this procedure. Several methods have been introduced to accelerate the healing time and reduction of patient's pain during first days after surgery. Low-level lasers have shown promising results in biostimulation of cell growth and differentiation in cultures. However, there are lack of well designed double blind placebo controlled randomized controlled clinical studies evaluating the effects of Low-level laser therapy in acceleration of wound healing and pain relief of patients undergoing free gingival grafts.

Studietype

Intervensjonell

Registrering (Faktiske)

12

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • lack of keratinized tissue around teeth (bilateral)

Exclusion Criteria:

  • patients with systemic diseases
  • non-cooperative patients
  • smokers
  • poor oral hygiene
  • root surface restorations or active caries

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: low-level laser therapy
Low-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site
Stråling: Low-level laser therapy
Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds
Andre navn:
  • low-level laser
Placebo komparator: Turned-off laser
The same protocol is applied in te donor site, unless the laser is remained off.
Stråling: Turned-off laser
Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.
Andre navn:
  • Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
degree of epithelialization
Tidsramme: At day 7

3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling

  • Complete epithelialization: bubble was not seen
  • Partial epithelialization: bubbles were seen in lesser than half of donor site
  • No epithelialization: bubble were seen in more than half of donor site
At day 7
degree of epithelialization
Tidsramme: At day 14

3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling

  • Complete epithelialization: bubble was not seen
  • Partial epithelialization: bubbles were seen in lesser than half of donor site
  • No epithelialization: bubble were seen in more than half of donor site
At day 14
degree of epithelialization
Tidsramme: At day 21

3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling

  • Complete epithelialization: bubble was not seen
  • Partial epithelialization: bubbles were seen in lesser than half of donor site
  • No epithelialization: bubble were seen in more than half of donor site
At day 21

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual analogue scale (VAS) pain score
Tidsramme: at day 1
ask from patient about numbers of tablet consumption,record VAS analysis
at day 1
Visual analogue scale (VAS) pain score
Tidsramme: at day 2
ask from patient about numbers of tablet consumption,record VAS analysis
at day 2
Visual analogue scale (VAS) pain score
Tidsramme: at day 3
ask from patient about numbers of tablet consumption,record VAS analysis
at day 3
Visual analogue scale (VAS) pain score
Tidsramme: at day 4
ask from patient about numbers of tablet consumption,record VAS analysis
at day 4
Visual analogue scale (VAS) pain score
Tidsramme: at day 5
ask from patient about numbers of tablet consumption,record VAS analysis
at day 5
Visual analogue scale (VAS) pain score
Tidsramme: at day 6
ask from patient about numbers of tablet consumption,record VAS analysis
at day 6
Visual analogue scale (VAS) pain score
Tidsramme: at day 7
ask from patient about numbers of tablet consumption,record VAS analysis
at day 7
Visual analogue scale (VAS) pain score
Tidsramme: at day 14
ask from patient about numbers of tablet consumption,record VAS analysis
at day 14
Clinical healing
Tidsramme: at day 1
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 1
Clinical healing
Tidsramme: at day 2
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 2
Clinical healing
Tidsramme: at day 7
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 7
Clinical healing
Tidsramme: at day 14
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 14
Clinical healing
Tidsramme: at day 21
Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.
at day 21

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tehran University of Medical Sciences

Etterforskere

  • Studieleder: Neda Moslemi, Laser Research Center of Dentistry, Tehran University of Medical Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2012

Primær fullføring (Faktiske)

1. august 2012

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

15. desember 2012

Først innsendt som oppfylte QC-kriteriene

6. september 2016

Først lagt ut (Anslag)

12. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. september 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 91-01-97-16886

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Gingival resesjon

Kliniske studier på Low-level laser therapy

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