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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Test product
Mouthwash containing 0.2% w/v Chlorhexidine digluconate
Intervention: 0.2% w/v Chlorhexidine digluconate (Drug)
Test product
Mouthwash containing 0.2% w/v Chlorhexidine digluconate
Intervention: Sodium fluoride toothpaste (Aquafresh Mild & Minty) (Drug)
Control
Sodium fluoride toothpaste (Aquafresh Mild & Minty)
Intervention: Sodium fluoride toothpaste (Aquafresh Mild & Minty) (Drug)
Outcomes
Primary Outcomes
Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
Time Frame: At Day 3
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.
Secondary Outcomes
- 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)(At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7)
- Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery(Up to 7 days post implant surgery)
- Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis(At Baseline)