Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Impact of E-Cigarette Smoking on Healing Response to Non-Surgical Periodontal Therapy

28. juni 2026 opdateret af: Ain Shams University

Impact of E-Cigarette Smoking on Healing Response to Non-Surgical Periodontal Therapy in the Management of Stage II Periodontitis (A Randomized Controlled Clinical Study With Biochemical Assessment )

the goal of this clinical trial is to compare the effect of vaping vs traditional smoking on non surgical periodontal therapy . the main question it aims to answer is what is the impact of traditional smoking and vaping on periodontal health and how do IL-1B and IL-20 serve as mediators in the inflammatory processes linked to periodontal disease?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

the goal of this clinical trial is to compare the effect of vaping vs traditional smoking on non surgical periodontal therapy . the main question it aims to answer is what is the impact of traditional smoking and vaping on periodontal health and how do IL-1B and IL-20 serve as mediators in the inflammatory processes linked to periodontal disease? .A randomized controlled clinical trial will be conducted on patients with periodontitis stage II . participants will be allocated to one of three groups: traditional smokers , vapers and non-smokers . the randomization process will ensure unbiased distribution of participants across the groups . periodontal health will be evaluated through clinical assesment ( probing depth as primary outcome, clinical attachemt level, bleeding on probing and GI ) then cytokine levels (IL-1B , IL-20) will be assessed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

117

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Egypten
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypten, 11566
        • faculty of dentistry , Ain shams 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

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • pts aged 20-40 years
  • pts with stage II periodontitis
  • systemically healthy with no chronic diseases
  • no current use of medication
  • participants have the same socioeconomic status
  • participants must be able to understand and comply with the study protocol and give informed consent

Exclusion Criteria:

  • pts with severe systemic diseases
  • recent use of immunosuppressants or medications that affect oral health
  • history of illicit drug use within the past 12 months
  • periodontal surgery or scaling within the last 6 months
  • participants in another clinical trial
  • vulnerable individuals as children and pregnant

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: traditional smokers
patients with stage II periodotitis who are conventional cigarette smokers and recieved non surgical periodontal therapy
Procedure: non surgical periodontal therapy
participants in all groups will recieve non surgical periodontal therapy including scaling and root planning performed using ultrasonic and hand instruments at baseline. oral hygiene instructions will be provided. periodontal parameters and GCF samples will be collected at baseline and follow up visit.
Aktiv komparator: e-cigarette smokers
pts with stage II periodontitis who are on e-cigarette smoking and recieved non surgical periodontal therapy
Procedure: non surgical periodontal therapy
participants in all groups will recieve non surgical periodontal therapy including scaling and root planning performed using ultrasonic and hand instruments at baseline. oral hygiene instructions will be provided. periodontal parameters and GCF samples will be collected at baseline and follow up visit.
Aktiv komparator: non smokers
pts with stage II periodontitis who are non smokers and recieved non surgical periodontal therapy
Procedure: non surgical periodontal therapy
participants in all groups will recieve non surgical periodontal therapy including scaling and root planning performed using ultrasonic and hand instruments at baseline. oral hygiene instructions will be provided. periodontal parameters and GCF samples will be collected at baseline and follow up visit.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
probing depth (PD)
Tidsramme: baseline and 2 months follow up
assessment of periodontal probing depth measured in millimeters using a UNC -15 periodontal probe. PD will be measured from the gingival margin to the base of the periodontal pocket at six sites per tooth
baseline and 2 months follow up
clinical attachment loss
Tidsramme: baseline and 2 months follow up after non surgical periodontal surgery
assessment of CAL measured in millimeters using a UNC-15 periodontal probe. CAL will be measured from (CEJ) to the base of the pocket at 6 sites per tooth
baseline and 2 months follow up after non surgical periodontal surgery
plaque index
Tidsramme: baseline and 2 months follow up after NSPT
assessment of plaque accumulation using plaque index ( Silness and Loe plaque index )
baseline and 2 months follow up after NSPT
bleeding on probing
Tidsramme: baseline and 2 months follow up after NSPT
assessment of gingival bleeding following periodontal probing and recorded as the percentage of bleeding sites.
baseline and 2 months follow up after NSPT

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
interleukin-1B level in GCF
Tidsramme: baseline and 2 months after NSPT
assessment of IL-1B level in GCF using ( ELISA ). results will be expressed according to assay manufacturer's instructions
baseline and 2 months after NSPT
IL-20 level in GCF
Tidsramme: baseline and 2 month after NSPT
assessment of IL-20 levels in GCF samples using (ELISA ). results will be expressed according to assay manufacturer's instructions
baseline and 2 month after NSPT

Samarbejdspartnere og efterforskere

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

Sponsor

Ain Shams University

Efterforskere

  • Ledende efterforsker: Mohamed M Al Bahrawy, Assoc. pro, faculty of dentistry ,Ain shams university

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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)

13. oktober 2025

Primær færdiggørelse (Faktiske)

21. december 2025

Studieafslutning (Faktiske)

4. marts 2026

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

20. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1449 (CSL Behring)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD will not be shared to protect participant confidentiality and due to ethical considerations. only summarized and deidentified data will be published

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 Paradentose

Kliniske forsøg med non surgical periodontal therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cambodia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner