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Diode Laser Therapy As An Adjunct To Scaling And Root Planing

19. januar 2017 opdateret af: Veena H.R, KLE Society's Institute of Dental Sciences

Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study

Laser therapy has been proposed as a novel treatment option in controlling subgingival microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis (CP).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy.

The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

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

30 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
  • Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm

Exclusion Criteria:

  • Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
  • Subjects on antibiotics or immunosuppressants.
  • Chronic smokers, alcoholics, smokeless tobacco users.
  • Subjects with acute illnesses/acute intraoral lesions.
  • Pregnant women
  • Subjects who had undergone extensive restorative dental treatment.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Ultrasonic Scaling, Root planing
Ultrasonic Scaling and Root planing at day 0 and at 1 week.
Procedure: Ultrasonic Scaling and root planing
Procedure of scaling and root planing at day 0 and at 1 week
Eksperimentel: 980 nm diode Laser irradiation
Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.
Procedure: Ultrasonic Scaling and root planing
Procedure of scaling and root planing at day 0 and at 1 week
Procedure: 980 nm diode laser irradiation
Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in levels of P.gingivalis
Tidsramme: 14 weeks
Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.
14 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in gingival index
Tidsramme: 14 weeks
Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups
14 weeks
Change in plaque index
Tidsramme: 14 weeks
Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks
14 weeks
Change in probing pocket depth
Tidsramme: 14 weeks
Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks
14 weeks
Change in clinical attachment level
Tidsramme: 14 weeks
Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks
14 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

KLE Society's Institute of Dental Sciences

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

1. marts 2013

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Faktiske)

1. september 2013

Datoer for studieregistrering

Først indsendt

7. januar 2017

Først indsendt, der opfyldte QC-kriterier

19. januar 2017

Først opslået (Skøn)

23. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KLESocietyIDS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk paradentose

Kliniske forsøg med Ultrasonic Scaling and root planing

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mauritania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner