- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04311905
Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues
16. marts 2020 opdateret af: Hend Hamdy Ismail, Ain Shams University
Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues (A Randomized Clinical Trial )
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo.
Egypt.
24 eligible patients were selected and included in the study to compare healing ability of diode laser activated irrigation versus conventional root canal treatment using CBCT
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Sample size is 24 , 24 Patients were randomly distributed in 2 groups , one group of patients received laser activated irrigation LAI during root canal treatment and the other group received no treatment just conventional RCT.
• Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not receive a laser activated irrigation Group A LAI :Disinfection were done by using 5 ml of 2.5% sodium hypochlorite irrigation for 1 minute.
Irrigation will be performed with a 30-gauge needle side vented The irrigation needles were introduced passively up to 2 mm away the working length.
After irrigation Laser treatment will be performed with a diode laser, at a wavelength of 980 nm with a repeated pulse mode using a pulse duration of 5sec per canal and a pulse interval of 0.2 ms.
The laser irradiation were delivered for 1 minute into the canal up to 1 mm short of the working length, with circling movements from the apical part moving towards the coronal part Group B : received mock laser intervention , conventional Root canal treatment with 2.5% sodium hypochlorite CBCT was taken pre-operative and another one was taken after 12 month , both volumetric and linear measurements were calculated
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Cairo, Egypten
- Endodontic department - Faculty of Dentistry Ainshams 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 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adult patients age between 18-50 years
- Medically free patients.
- Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
- Preoperative Pain
- Sensitivity to percussion
- Periapical radiographic X-ray showing periapical lesion with no gutta percha in canal
- Occlusal contact with opposing teeth
Exclusion Criteria:
- Pregnant females.
- Patients having a significant systemic disorder or history of drug abuse
- Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
- Patients having bruxism or clenching
Teeth having:
- No occlusal contact
- No sensitivity to percussion
- Greater than grade I mobility.
- Pocket depth greater than 5mm.
- No possible restorability
- Procedural errors
- Previous Root canal treatment
- Open apex
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Laser activated irrigation LAI
Diode Laser activated irrigation
|
Diode laser activated irrigation
Andre navne:
|
Placebo komparator: conventional root canal treatment
mock LAI , conventional root canal treatment 2.5% sodium hypochlorite
|
mock Laser activated irrigation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Assess post-operative healing using CBCT in a period of 12 month when Laser activated irrigation was used during root canal treatment
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Maram Obeid, PhD, Ainshams university
- Studiestol: Ehab Hassanien, PhD, Ainshams 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. juli 2017
Primær færdiggørelse (Faktiske)
1. juli 2019
Studieafslutning (Faktiske)
1. januar 2020
Datoer for studieregistrering
Først indsendt
7. marts 2020
Først indsendt, der opfyldte QC-kriterier
16. marts 2020
Først opslået (Faktiske)
17. marts 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- END 16-15D
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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