Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
21. juni 2017 opdateret af: GlaxoSmithKline
A Clinical Study to Evaluate the Efficacy of Pre-procedural and Pre-surgical Rinsing With an Antimicrobial Agent in Reducing Bacteria in Dental Aerosols and in the Oral Cavity
The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the mouth 3 days post implant surgery.
The study will be conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL) Eastman Dental Institute.
Participants will be those who require a single and simple surgical implant to be placed, and will be recruited from new patient referrals within the Eastman Dental Hospital
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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London, Det Forenede Kongerige, WC1X 8LD
- GSK Investigational Site
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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 64 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged between 18-64 years old.
- Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general and mental health with, in the opinion of the investigator or medically qualified designee:
- No clinically significant and relevant abnormalities in medical history or upon oral examination.
- Absence of any condition that could affect the participant's safety or well being or their ability to understand and follow study procedures and requirements.
- Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception
Dental Health
- Good overall oral health in the opinion of investigator.
- A minimum of 20 permanent teeth.
- Requiring a single and simple implant (single tooth replacement with no bone augmentation required for implant placement).
- Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Exclusion Criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- Use of antibiotics within 14 days prior to the Baseline visit or Implant surgery visit.
- An employee of the sponsor or the study site or members of their immediate family
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Test product
Mouthwash containing 0.2% w/v Chlorhexidine digluconate
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Participants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse.
Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily.
They will then rinse their mouth thoroughly with water after brushing
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Placebo komparator: Control
Sodium fluoride toothpaste (Aquafresh Mild & Minty)
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Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily.
They will then rinse their mouth thoroughly with water after brushing
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
Tidsramme: At Day 3
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The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue.
An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube.
The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.
The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant.
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At Day 3
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)
Tidsramme: At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
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The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue.
An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube.
The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.
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At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
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Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery
Tidsramme: Up to 7 days post implant surgery
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The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue.
An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube.
The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.
The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery
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Up to 7 days post implant surgery
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Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis
Tidsramme: At Baseline
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Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol.
Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery.
After 30 minutes, the settle plates lids were replaced.
This was repeated during the dental prophylaxis procedure using 5 fresh settle plates.
All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days.
The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation
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At Baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. februar 2015
Primær færdiggørelse (Faktiske)
1. juni 2015
Studieafslutning (Faktiske)
29. februar 2016
Datoer for studieregistrering
Først indsendt
15. december 2014
Først indsendt, der opfyldte QC-kriterier
15. december 2014
Først opslået (Skøn)
18. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202200
- 2014-003222-40 (EudraCT nummer)
- RH02604 (Anden identifikator: GSK)
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